[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"New Zealand\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":686},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,370,0,25,[9,49,76,100,129,154,177,208,236,260,287,312,334,356,385,412,443,466,491,518,566,602,623,643,665],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100594352","phase-2-a-study-to-assess-the-efficacy-safety-and-tolerability-of-imvt-1402-as-treatment-for-adult-participants-with-graves-disease-100594352",false,"NCT07018323","A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease","A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease","Inclusion Criteria:\n\n* Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.\n* Male or female participants aged ≥ 18 years.\n* Participants with diagnosis of GD who are hyperthyroid despite ATD treatment.\n* Other, more specific inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.\n* Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.\n* Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and\u002For are planning corrective surgery\u002Firradiation or medical therapy for TED during study participation.\n* Additional exclusion criteria are defined in the protocol.","ALL","18 Years","75 Years",{"count":21,"type":22},210,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.",[28],"Graves' Disease",[30,31,32,33,34,35],"IMVT-1402","Graves' disease","Thyroid-Stimulating Hormone Receptor","Immunoglobulin G","Antithyroid drug","Imeroprubart","RECRUITING","2026-08-24",{"date":39,"type":40},"2026-08-25","ACTUAL",{"date":42,"type":40},"2025-06-19",{"date":44,"type":22},"2027-05",{"name":46,"class":47},"Immunovant Sciences GmbH","INDUSTRY",163,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100587506","phase-3-a-study-to-assess-the-long-term-safety-of-karxt-for-the-treatment-of-manic-episodes-in-bipolar-i-disorder-balsam-3-100587506","NCT06929273","A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)","A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)","Inclusion Criteria:\n\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  a. Participants must have completed treatment period of parent study.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania.\n  2. Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.\n  3. Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.\n  4. Participants does not require hospitalization for acute mania.\n\nExclusion Criteria:\n\n* All participants:\n\n  1\\. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS.\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  1\\. Discontinuation from any KarXT parent studies.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).\n  2. Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.\n  3. Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test.\n  4. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.\n  5. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","65 Years",{"count":58,"type":22},450,[60],"PHASE3","This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)\n\nThe primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.",[63],"Bipolar Disorder Type I With Mania",[65,66,67],"Bipolar-I disorder","Mania","Bipolar-I disorder with Mania",{"date":39,"type":40},{"date":70,"type":40},"2025-07-18",{"date":72,"type":22},"2028-06-13",{"name":74,"class":47},"Bristol-Myers Squibb",174,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100520674","bradycardia-pacemaker-with-av-interval-modulation-for-blood-pressure-treatment-100520674","NCT06059638","BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT","BACKBEAT","Inclusion Criteria:\n\n1. Patient has or is indicated for a dual-chamber pacemaker. Visit 1 can be performed within 30 days prior to a planned implant of a Medtronic Astra\u002FAzure dual-chamber pacemaker system or at any time thereafter\n2. On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug\n3. Office SBP ≥135 mmHg and \\\u003C180 mmHg\n4. Average 24-Hour aSBP ≥130 mmHg and \\\u003C170 mmHg\n\nExclusion Criteria:\n\n1. LVEF \\\u003C50%\n2. NYHA Class III-IV\n3. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months\n4. Myocardial infarction (MI) within 3 months\n5. Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months\n6. Permanent atrial fibrillation\n7. Mitral valve regurgitation greater than or equal to grade 3\n8. Aortic stenosis with a valve area less than 1.5 cm2\n9. Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)\n10. Has an existing active cardiac device or neurostimulator other than the recent Astra\u002FAzure pacemaker implant",{"count":84,"type":22},500,[86],"NA","A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra\u002FAzure pacemaker.",[89,90,91],"Hypertension","Hypertension, Systolic","Hypertension, Essential",{"date":39,"type":40},{"date":94,"type":40},"2023-12-27",{"date":96,"type":22},"2029-08",{"name":98,"class":47},"Orchestra BioMed, Inc",130,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100409600","phase-2-phase-2-trial-of-adagrasib-monotherapy-and-in-combination-with-pembrolizumab-and-a-phase-3-trial-of-adagrasib-in-combination-in-patients-with-a-kras-g12c-mutation-krystal-7-100409600","NCT04613596","Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7","A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","Inclusion Criteria:\n\n* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS\n* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\\>=50%\n* Phase 3: Presence of measurable disease per RECIST1.1\n* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:\n\n  1. No evidence of brain metastases\n  2. Untreated brain metastases not needing immediate local therapy\n  3. Previously treated brain metastases not needing immediate local therapy\n\nExclusion Criteria:\n\n* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).\n* Phase 2: Active brain metastases\n* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:\n\n  1. Any untreated brain lesions \\> 2.0 cm in size\n  2. Any brainstem lesions\n  3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \\> 10 mg of prednisone (or equivalent) prior to randomization.\n  4. Have poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy\n* Phase 3: Radiation to the lung \\> 30 Gy within 6 months prior to the first dose of study treatment",{"count":108,"type":22},626,[25,60],"The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.\n\nThe Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \\>=50% and who are candidates for first line treatment.",[112,113],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[115,116,117,113,118,119,120],"KRAS G12C","Non-small cell lung cancer","NSCLC","Adagrasib","Krazati","TPS",{"date":39,"type":40},{"date":123,"type":40},"2020-12-02",{"date":125,"type":22},"2029-10-31",{"name":127,"class":47},"Mirati Therapeutics Inc.",770,{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":153},"100529324","dinutuximab-with-chemotherapy-surgery-and-stem-cell-transplantation-for-the-treatment-of-children-with-newly-diagnosed-high-risk-neuroblastoma-100529324","NCT06172296","Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma","A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma","Inclusion Criteria:\n\n* Patients must be enrolled on APEC14B1 and have consented to testing through the Molecular Characterization Initiative (MCI), prior to enrollment on ANBL2131\n* ≤ 30 years at the time of initial diagnosis with high-risk disease\n* \\* Must have a diagnosis of neuroblastoma (NBL) or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines\n\n  * Newly diagnosed, high risk neuroblastoma (HRNBL) defined as one of the following:\n\n    * Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M and MYCN amplification\n    * Age ≥ 547 days and INRG stage M regardless of biologic features (clinical MYCN testing not required prior to enrollment)\n    * Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to stage M without systemic chemotherapy\n    * Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to stage M without systemic chemotherapy (clinical MYCN testing not required prior to enrollment)\n* Patients must have a body surface area (BSA) ≥ 0.25 m\\^2\n* No prior anti-cancer therapy except as outlined below:\n\n  * Patients initially recognized to have high-risk disease treated with topotecan\u002Fcyclophosphamide initiated on an emergent basis and within allowed timing, and with consent\n  * Patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high-risk disease but subsequently found to meet the criteria\n  * Patients who received localized emergency radiation to sites of life threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis\n* Human immunodeficiency virus (HIV) -infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* A serum creatinine based on age\u002Fsex as follows:\n\n  * 1 month to \\\u003C 6 months: Male 0.4 mg\u002FdL and female 0.4mg\u002FdL\n  * 6 months to \\\u003C 1 year: Male 0.5 mg\u002FdL and female 0.5 mg\u002FdL\n  * 1 to \\\u003C 2 years: Male 0.6 mg\u002FdL and female 0.6 mg\u002FdL\n  * 2 to \\\u003C 6 years: Male 0.8 mg\u002FdL and female 0.8 mg\u002FdL\n  * 6 to \\\u003C 10 years: Male 1 mg\u002FdL and female 1 mg\u002FdL\n  * 10 to \\\u003C 13 years: Male 1.2 mg\u002FdL and female 1.2 mg\u002FdL\n  * 13 to \\\u003C 16 years: Male 1.5 mg\u002FdL and female 1.4 mg\u002FdL\n  * ≥ 16 years: Male 1.7 mg\u002FdL and female 1.4 mg\u002FdL\n\n    * The threshold creatinine values were derived from the Schwartz formula for estimating glomerular filtration rate (GFR) utilizing child length and stature data published by the Centers for Disease Control (CDC)\n  * or a 24-hour urine creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m\\^2 or\n  * or a GFR ≥ 70 mL\u002Fmin\u002F1.73 m\\^2. GFR must be performed using direct measurement with a nuclear blood sampling method or direct small molecule clearance method (iothalamate or other molecule per institutional standard)\n\n    * Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age\n* Serum glutamic pyruvic transaminase (SGPT) (Alanine aminotransferase \\[ALT\\]) ≤ 10 x ULN\\*\n\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL\n* \\* Shortening fraction of ≥ 27% by echocardiogram, or\n\n  * Ejection fraction of ≥ 50% by echocardiogram or radionuclide angiogram\n* Ability to tolerate Peripheral Blood Stem Cell (PBSC) collection:\n\nNo known contraindication to PBSC collection. Examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and\u002For the apheresis procedure\n\nExclusion Criteria:\n\n* Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features\n* Patients ≥ 547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features\n* Patients with known bone marrow failure syndromes\n* Patients on chronic immunosuppressive medications (e.g., tacrolimus, cyclosporine, corticosteroids) for reasons other than prevention\u002Ftreatment of allergic reactions and adrenal replacement therapy are not eligible. Topical and inhaled corticosteroids are acceptable\n* Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required prior to enrollment for female patients of childbearing potential\n* Lactating females who plan to breastfeed their infants\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, food and drug administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","30 Years",{"count":138,"type":22},478,[60],"This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neuroblastoma cells, but is not present on many healthy or normal cells in the body. When dinutuximab binds to the neuroblastoma cells, it helps signal the immune system to kill the tumor cells. This helps the cells of the immune system kill the cancer cells, this is a type of immunotherapy. When chemotherapy and immunotherapy are given together, during the same treatment cycle, it is called chemoimmunotherapy. This clinical trial randomly assigns patients to receive either standard chemotherapy and surgery or chemoimmunotherapy (chemotherapy plus dinutuximab) and surgery during Induction therapy. Chemotherapy drugs administered during Induction include, cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, and doxorubicin. These drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Upon completion of 5 cycles of Induction therapy, a disease evaluation is completed to determine how well the treatment worked. If the tumor responds to therapy, patients receive a tandem transplantation with stem cell rescue. If the tumor has little improvement or worsens, patients receive chemoimmunotherapy on Extended Induction. During Extended Induction, dinutuximab is given with irinotecan, temozolomide. Patients with a good response to therapy move on to Consolidation therapy, when very high doses of chemotherapy are given at two separate points to kill any remaining cancer cells. Following, transplant, radiation therapy is given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of Induction. The final stage of therapy is Post-Consolidation. During Post-Consolidation, dinutuximab is given with isotretinoin, with the goal of maintaining the response achieved with the previous therapy. Adding dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy may be better at treating children with newly diagnosed high-risk neuroblastoma.",[142,143],"Ganglioneuroblastoma, Nodular","Neuroblastoma","2026-08-22",{"date":39,"type":40},{"date":147,"type":40},"2024-04-19",{"date":149,"type":22},"2029-12-31",{"name":151,"class":152},"National Cancer Institute (NCI)","NIH",179,{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":17,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},"100446866","phase-1-a-study-of-the-drug-selinexor-with-radiation-therapy-in-patients-with-newly-diagnosed-diffuse-intrinsic-pontine-dipg-glioma-and-high-grade-glioma-hgg-100446866","NCT05099003","A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)","A Phase 1\u002F2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG)","Inclusion Criteria:\n\n* PRE ENROLLMENT: Patients must be =\\\u003C 25 years of age at the time of enrollment on APEC14B1 part A central nervous system (CNS)\u002Fhigh grade glioma (HGG) pre-enrollment eligibility screening\n\n  * Please note:\n\n    * This required age range applies to pre-enrollment eligibility for all HGG patients. Individual treatment protocols may have different age criteria.\n    * Non-DIPG patients with tumors that do not harbor an H3K27M-mutation and are \\>= 18 years of age will not be eligible to enroll on ACNS1821 (Step 1).\n* PRE ENROLLMENT: Patient is suspected of having localized, newly diagnosed HGG, excluding metastatic disease, OR patient has an institutional diagnosis of DIPG\n\n  * Please note: there are specific radiographic criteria for DIPG patient enrollment on ACNS1821 (Step 1)\n  * As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.\n* PRE ENROLLMENT:\n\n  * For patients with non-pontine tumors: Patients and\u002For their parents or legal guardians must have signed informed consent for eligibility screening on APEC14B1 Part A.\n  * For patients with DIPG: Patients and\u002For their parents or legal guardians must have signed informed consent for ACNS1821.\n  * Note: As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.\n* PRE ENROLLMENT:\n\n  * For patients with non-pontine tumors only, the specimens obtained at the time of diagnostic biopsy or surgery must be submitted through APEC14B1 ASAP, preferably within 5 calendar days of definitive surgery\n* STEP 1: Patients must be \\>= 12 months and =\\\u003C 21 years of age at the time of enrollment\n* STEP 1: Patients must have newly-diagnosed DIPG or HGG (including DMG).\n* STEP 1: Stratum DIPG (Closed with Amendment #4)\n\n  * As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.\n  * Patients with newly-diagnosed typical DIPG, defined as tumors with a pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons on at least 1 axial T2 weighted image, are eligible. No histologic confirmation is required.\n  * Patients with pontine tumors that do not meet radiographic criteria for typical DIPG (e.g., focal tumors or those involving less than 2\u002F3 of the pontine cross-sectional area with or without extrapontine extension) are eligible if the tumors are biopsied and proven to be high-grade gliomas (such as anaplastic astrocytoma, glioblastoma, high-grade glioma not otherwise specified \\[NOS\\], and\u002For H3 K27M-mutant) by institutional diagnosis.\n* STEP 1: Stratum DMG (with H3 K27M mutation) (Closed with Amendment #4)\n\n  * As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.\n  * Patients must have newly-diagnosed non-pontine H3 K27M-mutant HGG without BRAF V600 or IDH1 mutations as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1\n  * Note: Patients need not have either measurable or evaluable disease, i.e., DMG patients may have complete resection of their tumor prior to enrollment. Primary spinal tumors are eligible for enrollment. For rare H3 K27M-mutant HGG in non-midline structures (e.g., cerebral hemispheres), these patients will be considered part of Stratum DMG.\n* STEP 1: Stratum HGG (without H3 K27M mutation)\n\n  * Patients must have newly-diagnosed non-pontine H3 K27M-wild type HGG without BRAF V600 or IDH1 mutations as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1\n  * Please note:\n\n    * Patients who fall in this category and who are \\>= 18 years of age are not eligible due to another standard-of-care regimen (radiation\u002Ftemozolomide) that is available\n    * Patients need not have either measurable or evaluable disease, i.e., HGG patients may have complete resection of their tumor prior to enrollment. Primary spinal tumors are eligible for enrollment\n* STEP 1: Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* STEP 1: Peripheral absolute neutrophil count (ANC) \\>= 1000\u002FuL (within 7 days prior to step 1 enrollment)\n* STEP 1: Platelet count \\>= 100,000\u002FuL (transfusion independent) (within 7 days prior to step 1 enrollment)\n* STEP 1: Hemoglobin \\>= 8.0 g\u002FdL (may receive red blood cell \\[RBC\\] transfusions) (within 7 days prior to step 1 enrollment)\n* STEP 1: Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 (within 7 days prior to step 1 enrollment) or\n\nA serum creatinine based on age\u002Fsex as follows (within 7 days prior to step 1 enrollment):\n\n* Age \u002F Maximum Serum Creatinine (mg\u002FdL)\n\n  * 1 to \\\u003C 2 years \u002F male: 0.6; female: 0.6\n  * 2 to \\\u003C 6 years \u002F male: 0.8; female: 0.8\n  * 6 to \\\u003C 10 years \u002F male: 1; female: 1\n  * 10 to \\\u003C 13 years \u002F male: 1.2; female: 1.2\n  * 13 to \\\u003C 16 years \u002F male: 1.5; female: 1.4\n  * \\>= 16 years \u002F male: 1.7; female: 1.4\n\n    * STEP 1: Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) for age\n    * STEP 1: Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 135 U\u002FL. For the purpose of this study, the ULN for SGPT is 45 U\u002FL.\n    * STEP 1: Serum amylase =\\\u003C 1.5 x ULN\n    * STEP 1: Serum lipase =\\\u003C 1.5 x ULN\n    * STEP 1: No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \\> 94% if there is clinical indication for determination.\n    * STEP 1: Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled.\n    * STEP 1: Patients must be enrolled and protocol therapy must begin no later than 31 days after the date of radiographic diagnosis (in the case of non-biopsied DIPG patients only) or definitive surgery, whichever is the later date (Day 0).\n\nFor patients who have a biopsy followed by resection, the date of resection will be considered the date of definitive diagnostic surgery. If a biopsy only was performed, the biopsy date will be considered the date of definitive diagnostic surgery.\n\nExclusion Criteria:\n\n* STEP 1: Patients must not have received any prior therapy for their central nervous system (CNS) malignancy except for surgery and steroid medications.\n* STEP 1: Patients who are currently receiving another investigational drug are not eligible.\n* STEP 1: Patients who are currently receiving other anti-cancer agents are not eligible.\n* STEP 1: Patients \\>=18 years of age who have H3 K27M-wild type HGG.\n* STEP 1: Patients who have an uncontrolled infection.\n* STEP 1: Patients who have received a prior solid organ transplantation.\n* STEP 1: Patients with grade \\> 1 extrapyramidal movement disorder.\n* STEP 1: Patients with known macular degeneration, uncontrolled glaucoma, or cataracts.\n* STEP 1: Patients with metastatic disease are not eligible; MRI of spine with and without contrast must be performed if metastatic disease is suspected by the treating physician.\n* STEP 1: Patients with gliomatosis cerebri type 1 or 2 are not eligible, with the exception of H3 K27M-mutant bithalamic tumors.\n* STEP 1: Patients who are not able to receive protocol specified radiation therapy.\n* STEP 1:\n\n  * Female patients who are pregnant are ineligible since there is yet no available information regarding human fetal or teratogenic toxicities.\n  * Lactating females are not eligible unless they have agreed not to breastfeed their infants. It is not known whether selinexor is excreted in human milk.\n  * Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained.\n  * Sexually active patients of reproductive potential are not eligible unless they have agreed to use two effective methods of birth control (including a medically accepted barrier method of contraception, e.g., male or female condom) for the duration of their study participation and for 90 days after the last dose of selinexor. Abstinence is an acceptable method of birth control.","12 Months","21 Years",{"count":164,"type":22},132,[166,25],"PHASE1","This phase I\u002FII trial tests the safety, side effects, and best dose of selinexor given in combination with standard radiation therapy in treating children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) or high-grade glioma (HGG) with a genetic change called H3 K27M mutation. It also tests whether combination of selinexor and standard radiation therapy works to shrink tumors in this patient population. Glioma is a type of cancer that occurs in the brain or spine. Glioma is considered high risk (or high-grade) when it is growing and spreading quickly. The term, risk, refers to the chance of the cancer coming back after treatment. DIPG is a subtype of HGG that grows in the pons (a part of the brainstem that controls functions like breathing, swallowing, speaking, and eye movements). This trial has two parts. The only difference in treatment between the two parts is that some subjects treated in Part 1 may receive a different dose of selinexor than the subjects treated in Part 2. In Part 1 (also called the Dose-Finding Phase), investigators want to determine the dose of selinexor that can be given without causing side effects that are too severe. This dose is called the maximum tolerated dose (MTD). In Part 2 (also called the Efficacy Phase), investigators want to find out how effective the MTD of selinexor is against HGG or DIPG. Selinexor blocks a protein called CRM1, which may help keep cancer cells from growing and may kill them. It is a type of small molecule inhibitor called selective inhibitors of nuclear export (SINE). Radiation therapy uses high energy to kill tumor cells and shrink tumors. The combination of selinexor and radiation therapy may be effective in treating patients with newly-diagnosed DIPG and H3 K27M-Mutant HGG.",[169],"Malignant Glioma",{"date":39,"type":40},{"date":172,"type":40},"2022-05-31",{"date":174,"type":22},"2027-06-30",{"name":151,"class":152},127,{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":17,"minAge":184,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":207},"100652673","phase-3-open-label-phase-3b-study-to-evaluate-the-long-term-efficacy-and-safety-of-lerodalcibep-in-children-and-adolescents-6-to-17-years-of-age-with-heterozygous-familial-hypercholesterolemia-on-stable-diet-and-oral-lipid-lowering-therapy-100652673","NCT07775339","Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents With Familial Hypercholesterolemia","Open Label Phase 3b Study to Evaluate the Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents, 6 to 17 Years of Age, With Heterozygous Familial Hypercholesterolemia (LIBerate-Kids OLE)","Inclusion Criteria:\n\n1. Provision of written and signed informed consent\u002Fassent of the LIB003-016 trial prior to any study-specific procedure;\n2. Completion of the LIB003-008 study having received the last dose of study drug at Week 20 and completed the Week 24 visit;\n3. Male or female, 6 to 17 years of age (defined as from 6 to less than 18 years of age), at the first Screening Visit of the LIB003-008 study;\n4. Weight of \\>18 kg (40 lbs) and BMI \\\u003C17 and \\>42 kg\u002Fm2;\n5. On stable diet and lipid-lowering oral drug therapy (statins, ezetimibe, bile-acid sequestrants) or combinations thereof (excluded oral lipid-lowering agents are include mipomersen, lomitapide, and gemfibrozil);\n\nExclusion Criteria:\n\n1. History of any prior or active clinical condition or acute and\u002For unstable systemic disease compromising patient inclusion, at the discretion of the Investigator, which in the Investigator's opinion, would not be suitable for the study from a patient safety consideration or could interfere with the results of the study;\n2. Females of childbearing potential who are sexually active, not using or unwilling to use a highly effective form of contraception during the study and until 60 days after last dose of study drug, pregnant or breastfeeding, or who have a positive urine pregnancy test at the last Screening Visit;\n3. Patients who cannot be available for Protocol-required study visits or procedures, to the best of the patient's and Investigator's knowledge;\n4. A history, during the LIB003-008 study of prescription drug abuse, illicit drug use, or alcohol abuse according to medical history;\n5. Have any other finding which, in the opinion of the Investigator, would compromise the patient's safety or participation in the study;","6 Years","17 Years",{"count":187,"type":22},150,[60],"The goal is to assess the long term efficacy (LDL cholesterol reduction) and safety over 3 years of lerodalcibep (Lerochol) SC 300 mg QM administered by auto-injector (AI)\u002Fpre-filled pen (PFP) in male and female pediatric patients 6 to 17 years of age, with inherited high cholesterol (HeFH) on a stable diet and maximally tolerated oral LDL C lowering drug therapy such as statins who completed the 24 week placebo controlled base trial.\n\nThe main question\\[s\\] it aims to answer are:\n\nHow effective is Lerochol in maintaining LDL cholesterol reductions over years? How well is it tolerated and are there any safety concerns?\n\nParticipants will visit the clinic every month for 3 months and then home dosed with clinic visits every 3 months. They will undergo periodic physical exams, height and weight measurements, answer questions, have blood drawn from a vein in their arm, have blood pressure measurements, EKC heart tests, and receive monthly injections lasting about 5 seconds in their arms or abdomen with an autoinjector.",[191],"Heterozygous Familial Hypercholesterolemia (HeFH)",[193,194,195,196,197],"PCSK9 inhibitor","LDL-C","HeFH","lerodalcibep","pediatric","NOT_YET_RECRUITING","2026-08-21",{"date":39,"type":40},{"date":202,"type":22},"2027-01-20",{"date":204,"type":22},"2031-12-31",{"name":206,"class":47},"LIB Therapeutics LLC",5,{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":17,"minAge":215,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":23,"phases":218,"briefSummary":219,"conditions":220,"keywords":223,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":235},"100611500","phase-3-a-study-of-orforglipron-ly3502970-on-cardiovascular-outcomes-in-adults-with-atherosclerotic-cardiovascular-disease-andor-chronic-kidney-disease-attain-outcomes-100611500","NCT07241390","A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease (ATTAIN-Outcomes)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease","Inclusion Criteria:\n\n* Have established ASCVD and\u002For CKD\n\nExclusion Criteria:\n\n* Have type 1 diabetes\n* Have had a major heart condition within 60 days prior to screening\n* Have New York Heart Association Functional Classification Class IV heart failure","50 Years",{"count":217,"type":22},7140,[60],"The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and\u002For chronic kidney disease (CKD). Participation in the study will last about 5 years.",[221,222],"Atherosclerosis Cardiovascular Disease","Chronic Kidney Disease",[224,225,226,227],"Heart Disease","Kidney Disease","Outcomes","Stroke",{"date":37,"type":40},{"date":230,"type":40},"2025-12-01",{"date":232,"type":22},"2031-08",{"name":234,"class":47},"Eli Lilly and Company",567,{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":247,"conditions":248,"keywords":250,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":252,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":259},"100592970","phase-3-a-phase-iii-study-of-azd0780-on-major-adverse-cv-events-in-patients-with-a-history-of-ascvd-events-or-at-high-risk-for-a-first-event-100592970","NCT07000357","A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event","A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event","AZURE-Outcomes","Inclusion Criteria:\n\n* Meets one of the following:\n\n  1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening\n\n     Additional risk factors based on the level of the LDL-C and timing of MI or stroke:\n\n     o Participants with an LDL-C ≥ 75 mg\u002FdL (≥ 1.9 mmol\u002FL) need to have at least one of the other additional risk factors (i to viii) below.\n\n     ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD\n  2. Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg\u002FdL (≥ 2.6 mmol\u002FL), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii):\n\n  (i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases:\n  1. Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin\u002Fcreatinine ratio ≥ 30 mg\u002Fg) and\u002For persistent eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening\n  2. Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist\n  3. Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist\n  4. ABI \\\u003C 0.9 or \\> 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance\n\n     For (ii) and (iii), participants need to have at least one of the additional risk factors below:\n\n  \u003C!-- -->\n\n  1. CKD with eGFR x mL\u002Fmin\u002F1.73 m2\n  2. Current tobacco use\n  3. Age ≥ 65\n  4. T2DM (if included on the less significant atherosclerosis criterion iii)\n* Participants should receive a background lipid lowering regimen anticipated to achieve at least a \\~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and\u002For bempedoic acid).\n\nParticipants must achieve a stable background lipid lowering therapy \\> 28 days before screening.\n\nExclusion criteria:\n\n* Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.\n* Any revascularisation procedure planned within the next 3 months.\n* Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.\n* Calculated eGFR \\\u003C 15 mL \u002Fmin\u002F1.73 m2 at screening.\n* Any laboratory values with the following deviations at screening:\n\n  * AST or ALT \\> 3 × ULN\n  * TBL \\> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \\\u003C 1.5 × ULN)\n  * Fasting triglycerides ≥ 400 mg\u002FdL (≥ 4.52 mmol\u002FL).\n  * Creatine kinase \\> 5 × ULN\n  * Urine albumin\u002Fcreatinine ratio ≥ 500 mg\u002Fg\n* Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.\n* Inadequately treated hypothyroidism defined as TSH \\> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.\n* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.\n* Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.\n* Use of PCSK9 inhibitors: evolocumab\u002Falirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.",{"count":245,"type":22},15100,[60],"The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.",[249],"Cardiovascular Disease",[251],"Atherosclerotic Cardiovascular Disease",{"date":37,"type":40},{"date":254,"type":40},"2025-06-04",{"date":256,"type":22},"2029-10-26",{"name":258,"class":47},"AstraZeneca",1452,{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":275,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":286},"100568362","phase-1-phase-1-study-to-evaluate-safety-and-antiviral-activity-of-pbgene-hbv-in-adult-patients-with-chronic-hepatitis-b-100568362","NCT06680232","Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B","A Phase 1, Open-Label, First-in-Human, Dose Escalation (Part 1) and Expansion (Part 2) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of PBGENE-HBV in Participants With Chronic Hepatitis B (ELIMINATE-B)","ELIMINATE-B","Key Inclusion Criteria:\n\n* Male or women of non-child bearing potential\n* BMI 18.0 to 35.0\n* Good overall health deemed by the study Investigator\n* CHB infection documented at least 12 months prior to screening\n* HBeAg-negative CHB\n* Must be virologically suppressed on current NA treatment\n\nKey Exclusion Criteria:\n\n* No history of cirrhosis of the liver\n* No current infections of Hepatitis A, D, and E, human immunodeficiency virus (type 1 and 2), and no history of or current hepatitis C. In addition, no other active infections deemed clinically relevant.\n* No signs of hepatocellular carcinoma\n* Not received an organ transplant\n* No malignancy within 5 years of screening, except for specific cancers that are cured by surgical resection (e.g., basal cell skin cancer)\n* No investigational agent received within 6 months of screening","70 Years",{"count":270,"type":22},45,[166],"This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.",[274],"HEPATITIS B CHRONIC",[274,276,277,278],"Gene Therapy","Gene Editing","PBGENE-HBV",{"date":37,"type":40},{"date":281,"type":40},"2024-11-14",{"date":283,"type":22},"2027-06",{"name":285,"class":47},"Precision BioSciences, Inc.",7,{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":136,"enrollmentInfo":294,"targetDuration":4,"studyType":23,"phases":296,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":303,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":311},"100546927","phase-3-a-study-using-risk-factors-to-determine-treatment-for-children-with-favorable-histology-wilms-tumors-fhwt-100546927","NCT06401330","A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)","Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)","Inclusion Criteria:\n\n* Patients must be enrolled on APEC14B1 and consent to Part A - Eligibility Screening prior to enrollment on AREN2231.\n* Patients must be \\\u003C 30 years old at enrollment.\n* Patients with newly diagnosed Stage I-IV Favorable Histology Wilms Tumor confirmed by central review and with a qualifying Initial Stratum Assignment on APEC14B1-REN.\n* Patients must receive a qualifying Initial Stratum Assignment on APEC14B1-REN by Day 14 post-diagnostic procedure (nephrectomy or biopsy), where that procedure is Day 0.\n\n  * Patients must enroll on AREN2231 by Day 14.\n  * Exceptions: If patient reaches Day 14 (post initial diagnostic nephrectomy or biopsy) without receiving an Initial Stratum Assignment on APEC14B1-REN, patient will not be eligible for enrollment on AREN2231 unless all required materials (reports and Case Report Forms and specimens) for an Initial Stratum Assignment arrived by Day 7, but an Initial Stratum Assignment was not completed by Day 14. In these circumstances, after obtaining appropriate protocol consent, the patient may proceed with treatment according to local institutional staging and enroll within 5 calendar days of notification of the central Initial Stratum Assignment being issued, only if the AREN2231 Initial Stratum Assignment is in agreement with any treatment already initiated. If the Initial Stratum Assignment is not in agreement with the local institution's assessment then the patient will be ineligible for AREN2231.\n* All sites must have sent or plan to send diagnostic tumor sample for molecular testing through a Clinical Laboratory Improvement Act (CLIA)-certified (or equivalent if outside of the United States \\[US\\]) laboratory that can detect Loss of Heterozygosity (LOH) of chromosome 1p AND 16q, and gain of chromosome 1q. Patients potentially eligible for mVLR must also have LOH of chromosome 11p15 included.\n\n  * Note: Patients are eligible for enrollment prior to obtaining these molecular testing results, and it is strongly recommended that patients are enrolled before these results are available. However, molecular results must be returned and uploaded to APEC14B1-REN for integration into risk stratification by the required timepoints (specific timelines vary by treatment arm). Patients who do not have molecular results available by the arm-specific timepoints may be taken off protocol therapy.\n* Patients who have an upfront nephrectomy must have at least one lymph node sampled and confirmed as a lymph node by central pathology review to be eligible.\n\n  * Note: Lymph node sampling will also be required at delayed nephrectomy. Patients who do not have a lymph node sampled and confirmed as a lymph node by central pathology review at delayed nephrectomy will be taken off protocol therapy.\n* Karnofsky performance status must be ≥ 50 for patients \\> 16 years of age and the Lansky performance status must be ≥ 50 for patients ≤ 16 years of age.\n* ONLY TO PATIENTS WHO WILL RECEIVE CHEMOTHERAPY: Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) OR direct bilirubin ≤ 3X ULN for subjects with total bilirubin levels \\> 1.5 ULN (within 7 days prior to enrollment).\n* ONLY TO PATIENTS WHO WILL RECEIVE CHEMOTHERAPY: Aspartate aminotransferase (AST\u002Fserum glutamate oxaloacetic transaminase \\[SGOT\\]) OR alanine transaminase (ALT\u002Fserum glutamic pyruvate transaminase \\[SGPT\\]) ≤ 3X ULN OR ≤ 5 X ULN for patients with liver metastases (within 7 days prior to enrollment).\n* ONLY TO PATIENTS WHO WILL RECEIVE CHEMOTHERAPY: Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% (within 7 days prior to enrollment)\n\n  * Note: This criteria only applies to patients centrally classified as Stage IV. Stage II and III patients subsequently assigned to a doxorubicin arm will be off protocol therapy if they do not meet this criteria at time of cardiac function assessment.\n* Known HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.\n\nExclusion Criteria:\n\n* Patient with a diagnosis of Stage V Bilateral Wilms Tumor.\n* Patients who in the opinion of the investigator are not able to comply with the study procedures are not eligible.\n* Patients with any uncontrolled, intercurrent illness including but not limited to symptomatic congestive heart failure.\n* Patients with Stage I FHWT with a known or suspected Wilms Tumor predisposition syndrome or condition (contralateral nephrogenic rests and\u002For unilateral multicentric tumors) are excluded from treatment on the mVLR (Nephrectomy Only) arm.\n\n  * Notes:\n\n    * In the context of the renal tumor protocols, multicentric tumors and multifocal tumors are equivalent terms, and refer to the occurrence of two or more tumors arising within one kidney.\n    * Exclusion from the Nephrectomy Only arm applies to two groups of patients:\n\n      * Patients \\\u003C 4 years with Stage I FHWT other than epithelial subtype AND\n      * Stage I patients of any age with Epithelial WT\n    * For the purpose of exclusion from the Nephrectomy Only Arm, known or suspected WT predisposition syndromes or conditions are defined as follows:\n\n      * WT Predisposition Syndromes: Beckwith Wiedemann Spectrum, Denys Drash, Trisomy 18, Idiopathic Hemihypertrophy\u002FIsolated Lateralized Overgrowth, WAGR, Simpson-Golabi-Behmel, Bohring-Opitz, or other conditions considered by treating physician to predispose to WT.\n      * WT Predisposing Conditions:\n\n        * A unilateral WT and (radiologic or pathologic) determination of contralateral nephrogenic rest(s) AND\u002FOR\n        * Unilateral multicentric WT\n* Patients treated with partial nephrectomy at initial diagnosis are excluded from mVLR (Nephrectomy Only) arm.\n* Patients with lung metastases as the only metastatic site who already had complete resection of all radiologically evident lung nodules, and have at least one nodule confirmed pathologically as tumor.\n\n  * Please note: Those with lung metastases as the only metastatic site who have complete resection of all radiologically evident lung nodules after enrollment but prior to the lung imaging following Cycle 2 of DD-4A will be inevaluable for lung assessment and subsequent stratum assignment and will, therefore, come off protocol therapy.\n* Patients with known Charcot-Marie-Tooth syndrome.\n* Patients who have had prior tumor-directed chemotherapy or radiotherapy for the current diagnosis except for therapy delivered for an emergent issue, as medically indicated.\n* Patients who will potentially require doxorubicin on this study and have previously received doxorubicin for another diagnosis.\n* Patients receiving concurrent chemotherapy for a different diagnosis.\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.\n* Lactating females who plan to breastfeed their infants.\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.",{"count":295,"type":22},1656,[60],"This phase III trial studies using risk factors in determining treatment for children with favorable tissue (histology) Wilms tumors (FHWT). Wilms Tumor is the most common type of kidney cancer in children, and FHWT is the most common subtype. Previous large clinical trials have established treatment plans that are likely to cure most children with FHWT, however some children still have their cancer come back (called relapse) and not all survive. Previous research has identified features of FHWT that are associated with higher or lower risks of relapse. The term \"risk\" refers to the chance of the cancer coming back after treatment. Using results of tumor histology tests, biology tests, and response to therapy may be able to improve treatment for children with FHWT.",[299,300,301,302],"Stage I Mixed Cell Type Kidney Wilms Tumor","Stage II Mixed Cell Type Kidney Wilms Tumor","Stage III Mixed Cell Type Kidney Wilms Tumor","Stage IV Mixed Cell Type Kidney Wilms Tumor",{"date":39,"type":40},{"date":305,"type":40},"2025-04-15",{"date":307,"type":22},"2031-02-13",{"name":309,"class":310},"Children's Oncology Group","NETWORK",169,{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":162,"enrollmentInfo":319,"targetDuration":4,"studyType":23,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":333},"100462662","phase-3-chemotherapy-for-the-treatment-of-patients-with-newly-diagnosed-very-low-risk-and-low-risk-fusion-negative-rhabdomyosarcoma-100462662","NCT05304585","Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma","A Prospective Phase 3 Study of Patients With Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma","Inclusion Criteria:\n\n* All patients must be enrolled on APEC14B1 (NCT02402244) and consented to the Molecular Characterization Initiative (Part A) prior to enrollment and treatment on ARST2032 (this trial).\n* Patients must be =\\\u003C 21 years at the time of enrollment.\n* Patients must have newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell\u002Fsclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS) (institutional FOXO1 fusion results are acceptable). RMS types included under ERMS include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2020 World Health Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and spindle cell\u002Fsclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Enrollment in APEC14B1 is required for all patients.\n\n  * All patients will be evaluated for stage and clinical group. Note that clinical group designation assigned at the time of enrollment on study remains unchanged regardless of any second-look operation that may be performed.\n\n    * Patients will be eligible for the very low-risk stratum (Regimen VA) if they have Stage 1, CG I disease.\n    * Patients will be eligible for the low-risk stratum (Regimen VAC\u002FVA) if they have Stage 1, CG II disease, Stage 2, CG I or II disease, or Stage 1, CG III (orbit only) disease.\n  * Paratesticular Tumors: Staging ipsilateral retroperitoneal lymph node sampling (SIRLNS) is required for all patients \\>= 10 years of age with paratesticular tumors who do not have gross nodal involvement on imaging.\n  * Extremity Tumors: Regional lymph node sampling is required for histologic evaluation in patients with extremity tumors.\n  * Clinically or radiographically enlarged nodes must be sampled for histologic evaluation.\n* Patients must have a Lansky (for patients =\\\u003C 16 years of age) or Karnofsky (for patients \\> 16 years of age) performance status score of \\>= 50. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing performance score.\n* Peripheral absolute neutrophil count (ANC) \\>= 750\u002FuL (within 7 days prior to enrollment).\n* Platelet count \\>= 75,000\u002FuL (transfusion independent) (within 7 days prior to enrollment).\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 or a serum creatinine (within 7 days prior to enrollment) based on age\u002Fgender as follows:\n\n  * Age: 1 month to \\\u003C 6 months; Maximum serum creatinine (mg\u002FdL): 0.4 (male) : 0.4 (female)\n  * Age: 6 months to \\\u003C 1 year; Maximum serum creatinine (mg\u002FdL): 0.5 (male) : 0.5 (female)\n  * Age: 1 to \\\u003C 2 years; Maximum serum creatinine (mg\u002FdL): 0.6 (male) : 0.6 (female)\n  * Age: 2 to \\\u003C 6 years; Maximum serum creatinine (mg\u002FdL): 0.8 (male) : 0.8 (female)\n  * Age: 6 to \\\u003C 10 years; Maximum serum creatinine (mg\u002FdL): 1 (male) : 1 (female)\n  * Age: 10 to \\\u003C 13 years; Maximum serum creatinine (mg\u002FdL): 1.2 (male) : 1.2 (female)\n  * Age: 13 to \\\u003C 16 years; Maximum serum creatinine (mg\u002FdL): 1.5 (male) : 1.4 (female)\n  * Age \\>= 16 years; Maximum serum creatinine (mg\u002FdL): 1.7 (male) : 1.4 (female)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment), and\n\n  * If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be \\\u003C 3 x ULN for age.\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL.\n* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 135 U\u002FL\n\n  * If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be \\\u003C 3 x ULN for age\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.\n\nExclusion Criteria:\n\n* Patients who have received prior chemotherapy and\u002For radiation therapy for cancer prior to enrollment. Surgical resection alone of previous cancer(s) is permitted.\n* Patients who have received chemotherapy or radiation for non-malignant conditions (e.g., autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy.\n* Vincristine is sensitive substrate of the CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment.\n* Patients unable to undergo radiation therapy, if necessary, as specified in the protocol.\n* Evidence of uncontrolled infection.\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.\n* Lactating females who plan to breastfeed their infants.\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.",{"count":320,"type":22},205,[60],"Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.",[324,325,326],"Embryonal Rhabdomyosarcoma","Fusion-Negative Alveolar Rhabdomyosarcoma","Spindle Cell\u002FSclerosing Rhabdomyosarcoma",{"date":39,"type":40},{"date":329,"type":40},"2022-08-04",{"date":331,"type":22},"2030-06-30",{"name":309,"class":310},181,{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":215,"enrollmentInfo":341,"targetDuration":4,"studyType":23,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":355},"100457328","phase-3-thoracotomy-versus-thoracoscopic-management-of-pulmonary-metastases-in-patients-with-osteosarcoma-100457328","NCT05235165","Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma","A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma","Inclusion Criteria:\n\n* Patients must be \\\u003C 50 years at the time of enrollment.\n* Patients must have =\\\u003C 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being \\>= 3 mm and all of which must be =\\\u003C 3 cm size.\n\n  * Note: Patient must have eligibility confirmed by rapid central imaging review.\n* Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.\n* Patients must have a histological diagnosis of osteosarcoma.\n* Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.\n* Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery.\n* Newly diagnosed patients must be receiving or recently completed (within 60 days) systemic therapy considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.\n* Patients at time of 1st recurrence must have completed systemic therapy for their initial primary tumor, considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.\n\nExclusion Criteria:\n\n* Patients with unresectable primary tumor.\n* Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as \"central\" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi).\n* Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.\n* Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team.\n* Patients with evidence of extrapulmonary metastatic disease.\n* Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.",{"count":342,"type":22},62,[60],"This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.",[346,347,348],"Metastatic Malignant Neoplasm in the Lung","Metastatic Osteosarcoma","Osteosarcoma",{"date":39,"type":40},{"date":351,"type":40},"2022-04-01",{"date":353,"type":22},"2031-03-31",{"name":309,"class":310},233,{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":17,"minAge":363,"maxAge":162,"enrollmentInfo":364,"targetDuration":4,"studyType":23,"phases":365,"briefSummary":366,"conditions":367,"keywords":369,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":384},"100453322","phase-3-venetoclax-in-children-with-relapsed-acute-myeloid-leukemia-aml-100453322","NCT05183035","Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)","A Randomized Phase 3 Trial of Fludarabine\u002FCytarabine\u002FGemtuzumab Ozogamicin With or Without Venetoclax in Children With Relapsed AML","Inclusion Criteria\n\n* Participants must have enrolled on APAL2020SC, NCT Number: NCT04726241 prior to enrollment on ITCC-101\u002FAPAL2020D. (This is only applicable for participants in USA\u002FCanada\u002FAustralia\u002FNew Zealand sites\u002FBlood Cancer United territory).\n* Participants must be \\>28 days of age and \\\u003C 22 years of age at enrollment.\n* Participants must have one of the following:\n\n  1. Children, adolescents, and young adults with AML without demonstrated FLT3\u002Finternal tandem duplication (ITD) mutation. Ideally, the status of the mutation needs to be proven in the current relapse. Nevertheless, patients with previous FLT3\u002FITD negative test from prior lines can be included based on local results in order to not delay the start of treatment.\n  2. And participants must have AML which is either:\n\n     * Untreated second relapse, in participants who are sufficiently fit to undergo another round of intensive chemotherapy, or\n     * Untreated first relapse, in participants who cannot tolerate additional anthracycline containing chemotherapy per investigator discretion.\n* Participants must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2 (≥ 50% Lansky or Karnofsky score).\n* Participants must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to start of protocol treatment:\n\n  1. Cytotoxic chemotherapy: Must not have received cytotoxic chemotherapy within 14 days prior to start of protocol treatment, except for corticosteroids, low dose cytarabine or hydroxyurea that can be given up to 24 hours prior to start of protocol treatment.\n  2. Intrathecal cytotoxic therapy: No wash-out time is required for participants having received any combination of intrathecal cytarabine, methotrexate, and\u002For hydrocortisone.\n  3. Antibodies: ≥ 21 days must have elapsed from infusion of last dose of an antibody-drug conjugate before start of protocol treatment. For unmodified antibodies or T cell engaging antibodies, 2 half-lives must have elapsed before start of protocol treatment. Any toxicity related to prior antibody therapy must be recovered to Grade ≤ 1.\n  4. Interleukins, Interferons and Cytokines (other than Hematopoietic Growth Factors): ≥ 21 days after the completion of interleukins, interferon or cytokines (other than Hematopoietic Growth Factors) before start of protocol treatment.\n  5. Hematopoietic growth factors: ≥ 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or ≥7 days for short-acting growth factor before start of protocol treatment.\n  6. Radiation therapy (RT) (before start of protocol treatment):\n\n     * ≥ 14 days have elapsed for local palliative RT (small port);\n     * ≥ 84 days must have elapsed if prior craniospinal RT or if ≥ 50% radiation of pelvis;\n     * ≥ 42 days must have elapsed if other substantial bone marrow (BM) radiation.\n  7. Stem Cell Infusions (before start of protocol treatment):\n\n     * ≥ 84 days since allogeneic (non-autologous) bone marrow or stem cell transplant (with or without total body irradiation \\[TBI\\]) or boost infusion (any stem cell product; not including donor lymphocyte infusion \\[DLI\\]);\n     * No evidence of active graft versus host disease (GVHD).\n  8. Participants who are receiving cyclosporine, tacrolimus or other agents to treat or prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial. Participants must be off medications to treat or prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant for at least 14 days prior to enrollment.\n  9. Cellular Therapy: ≥ 42 days after the completion of donor lymphocyte infusion (DLI) or any type of cellular therapy (e.g., modified T cells, natural killer \\[NK\\] cells, dendritic cells, etc.) before start of protocol treatment.\n  10. Participants with prior exposure to venetoclax are eligible in this trial.\n* Adequate organ function:\n\n  1. Adequate Renal Function defined as:\n\n     * Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 60ml\u002Fmin\u002F1.73 m\\^2, or\n     * Normal serum creatinine based on age\u002Fsex\n  2. Adequate Liver Function defined as:\n\n     * Direct bilirubin \\\u003C 1.5 x upper limit of normal (ULN), and\n     * Alkaline phosphatase ≤ 2.5 x ULN, and\n     * Serum glutamic pyruvic transaminase (SGPT) alanine aminotransferase (ALT) ≤ 2.5 x ULN. If higher transaminases outside these ranges (up to 5x ULN) are due to a radiographically identifiable leukemia infiltrate, the participant will remain eligible. Transaminase elevation up to 5x ULN is also allowed in case of steatosis on echography.\n  3. Cardiac performance: Minimum cardiac function defined as:\n\n     * No history of congestive heart failure in need of medical treatment\n     * No pre-treatment diminished left ventricular function on echocardiography (shortening fraction \\[SF\\] \\\u003C 25% or ejection fraction \\[EF\\] \\\u003C 40%)\n     * No signs of congestive heart failure at presentation of relapse.\n* Participant, parent or guardian must sign and date informed consent and pediatric assent (when required), prior to the initiation of screening or study specific procedures, according to local law and legislation.\n\nExclusion Criteria\n\n* Participants who in the opinion of the investigator may not be able to comply with the study requirements of the study, are not eligible.\n* Participants with Down syndrome.\n* Participants with Acute promyelocytic leukemia (APL) or Juvenile myelomonocytic leukemia (JMML).\n* Participants with isolated CNS3 disease or symptomatic CNS3 disease.\n* Participants with malabsorption syndrome or any other condition that precludes enteral administration of venetoclax.\n* Participants who are currently receiving an investigational drug other than those specified for this study.\n* Participants with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known congenital bone marrow failure syndrome.\n* Participants with known prior allergy to any of the medications used in protocol therapy.\n* Participants with documented active, uncontrolled infection at the time of study entry.\n* Known hepatitis C virus (HCV), hepatitis B virus (HBV) (known positive hepatitis B virus (HBV) surface antigen (HBsAg) results), or human immunodeficiency virus (HIV) infection.\n* Concomitant Medications\n\n  * Participants who have received strong and moderate CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort within 7 days of the start of study treatment.\n  * Participants who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit within 3 days of the start of study treatment.\n  * Participants who have hypersensitivity to the active substance or to any of the excipients listed in summary of product characteristics (SPC).\n* Pregnancy or Breast-Feeding:\n\n  * Participants who are pregnant or breast-feeding.\n  * Participants of reproductive potential may not participate unless they have agreed to use a highly effective contraceptive method per Clinical Trial Facilitation Group (CTFG) guidelines for the duration of study therapy and at least 30 days after last dose of venetoclax, or 7 months after gemtuzumab ozogamicin treatment, or for 6 months after the completion of all study therapy, whichever is longer.\n  * Male participants must use a condom during intercourse and agree not to father a child or donate sperm during therapy and for the duration of study therapy and at least 30 days after last dose of venetoclax or 4 months after last dose of gemtuzumab ozogamicin, 6 months from the last dose of cytarabine, or 90-days after last exposure to any other chemotherapy, whichever is longer.\n\nAdditional criteria to receive a gemtuzumab ozogamicin infusion:\n\nGemtuzumab ozogamicin should not be given:\n\n* to participants with history of veno-occlusive disease (VOD)\u002FSinusoidal obstruction syndrome (SOS) grade 3 or 4\n* to participants with CD33 negative leukemic blasts (determined at local lab)\n\nNote that these participants are eligible for the study but will not be treated with gemtuzumab ozogamicin.","29 Days",{"count":99,"type":22},[60],"A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine\u002Fcytarabine\u002Fgemtuzumab ozogamicin \\[GO\\]) improves survival of children\u002Fadolescents\u002Fyoung adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.",[368],"Acute Myeloid Leukemia",[370,371,372,373,374,375],"Venetoclax","Gemtuzumab Ozogamicin","Fludarabine","Cytarabine","Relapsed refractory","Azacitidine",{"date":37,"type":40},{"date":378,"type":40},"2022-10-01",{"date":380,"type":22},"2031-04",{"name":382,"class":383},"PedAL BCU, LLC","OTHER",90,{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":392,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":395,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":405,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":411},"100418248","phase-1-the-pediatric-acute-leukemia-pedal-screening-trial---a-study-to-test-bone-marrow-and-blood-in-children-with-leukemia-that-has-come-back-after-treatment-or-is-difficult-to-treat---a-leukemia--lymphoma-society-and-childrens-oncology-group-study-100418248","NCT04726241","The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study","Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias","Inclusion Criteria:\n\n* Patients must be less than 22 years of age at the time of study enrollment\n* Patient must have one of the following at the time of study enrollment:\n\n  * Patient has known or suspected relapsed\u002Frefractory (including primary refractory) AML as defined in protocol\n\n    * This includes isolated myeloid sarcoma\n  * Patient has known or suspected relapsed\u002Frefractory (including primary refractory) myeloid leukemia of Down syndrome (ML-DS)\n  * Patient has known or suspected relapsed ALL as defined in protocol that meets one of the following criteria:\n\n    * Second or greater B-ALL medullary relapse, excluding KMT2Ar\n    * Any first or greater B-ALL medullary relapse involving KMT2Ar\n    * Any first or greater T-ALL medullary relapse with or without KMT2Ar\n  * Patient has known or suspected relapsed\u002Frefractory (including primary refractory) mixed phenotype acute leukemia (MPAL) as defined in protocol\n  * Patient has known or suspected de novo or relapsed\u002Frefractory (including primary refractory) treatment-related AML (t-AML)\n  * Patient has known or suspected de novo or relapsed\u002Frefractory (including primary refractory) myelodysplastic syndrome (MDS) or treatment-related myelodysplastic syndrome (t-MDS)\n\n    * Note: Relapsed\u002Frefractory disease includes stable disease, progressive disease, and disease relapse.\n  * Patient has known or suspected de novo or relapsed\u002Frefractory (including primary refractory) juvenile myelomonocytic leukemia (JMML)\n\n    * Note: Relapsed\u002Frefractory disease includes stable disease, progressive disease, and disease relapse.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","22 Years",{"count":394,"type":22},960,[166,25],"This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults.",[398,368,399,400,401,402,403,404],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia Post Cytotoxic Therapy","Juvenile Myelomonocytic Leukemia","Mixed Phenotype Acute Leukemia","Myelodysplastic Syndrome","Myelodysplastic Syndrome Post Cytotoxic Therapy","Myeloid Leukemia Associated With Down Syndrome",{"date":39,"type":40},{"date":407,"type":40},"2022-04-18",{"date":409,"type":22},"2030-12-31",{"name":382,"class":383},184,{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":17,"minAge":419,"maxAge":420,"enrollmentInfo":421,"targetDuration":4,"studyType":23,"phases":423,"briefSummary":424,"conditions":425,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":442},"100415034","phase-2-a-study-of-a-new-way-to-treat-children-and-young-adults-with-a-brain-tumor-called-nggct-100415034","NCT04684368","A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT","A Phase 2 Trial of Chemotherapy Followed by Response-Based Whole Ventricular &Amp; Spinal Canal Irradiation (WVSCI) for Patients With Localized Non-Germinomatous Central Nervous System Germ Cell Tumor","Inclusion Criteria:\n\n* Patients must be \\>= 3 years and \\\u003C 30 years at the time of study enrollment\n* Patients must be newly diagnosed with localized primary CNS NGGCT of the suprasellar and\u002For pineal region by pathology and\u002For serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or \\> 10 ng\u002FmL or human chorionic gonadotropin (hCG) beta \\> 100 mIU\u002FmL as confirmed by Rapid Central Marker Screening Review on APEC14B1-CNS. Suprasellar, pineal and bifocal tumors are included. (CSF tumor markers and cytology must be within 31 days prior to enrollment and start of protocol therapy \\[repeat if necessary\\]. Serum tumor markers, AFP and hCGbeta must be within 7 days prior to enrollment and start of protocol therapy \\[repeat if necessary\\]). Basal ganglia or other primary sites are excluded\n* Patients with any of the following pathological elements are eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant\u002Fimmature teratoma and mixed germ cell tumor (GCT) (i.e., may include some pure germinoma) if malignant elements listed above are present. Patients with only mature teratoma are excluded. Patients with pure germinoma admixed with mature teratoma are excluded (would be eligible for pure germinoma protocols)\n* Patients must have a cranial MRI with and without gadolinium at diagnosis\u002Fprior to enrollment. If surgical resection is performed, patients must have pre-operative and post operative brain MRI with and without gadolinium. The post operative brain MRI should be obtained within 72 hours of surgery. If patient has a biopsy only, post-operative brain MRI is recommended but not required (within 31 days prior to study enrollment and start of protocol therapy )\n* Patients must have a spine MRI with gadolinium obtained at diagnosis\u002Fprior to enrollment. Spine MRI with and without gadolinium is recommended (within 31 days prior to study enrollment and start of protocol therapy)\n* Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated. If a patient undergoes surgery and lumbar CSF cytology cannot be obtained at the time of surgery, then it should be performed at least 10 days following surgery and prior to study enrollment. False positive cytology can occur within 10 days of surgery\n* Patients must have RAPID CENTRAL TUMOR MARKER REVIEW CSF tumor markers obtained prior to enrollment unless medically contraindicated. Ventricular CSF obtained at the time of CSF diversion procedure (if performed) is acceptable for tumor markers but lumbar CSF is preferred. In case CSF diversion and biopsy\u002Fsurgery are combined, CSF tumor markers should be collected first\n* Peripheral absolute neutrophil count (ANC) \\>= 1000\u002FuL (within 7 days prior to enrollment)\n* Platelet count \\>= 100,000\u002FuL (transfusion independent) (within 7 days prior to enrollment)\n* Hemoglobin \\>= 8.0 g\u002FdL (may receive red blood cell \\[RBC\\] transfusions) (within 7 days prior to enrollment)\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 or a serum creatinine based on age\u002Fgender as follows (within 7 days prior to enrollment):\n\n  * Age: Maximum serum creatinine (mg\u002FdL)\n\n    * 3 to \\\u003C 6 years: 0.8 (male), 0.8 (female)\n    * 6 to \\\u003C 10 years: 1 (male), 1 (female)\n    * 10 to \\\u003C 13 years: 1.2 (male), 1.2 (female)\n    * 13 to \\\u003C 16 years: 1.5 (male), 1.4 (female)\n    * \\>= 16 years: male (1.7), 1.4 (female)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)\n* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 135 U\u002FL (within 7 days prior to enrollment)\n\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL\n* Central nervous system function defined as:\n\n  * Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled\n  * Patients must not be in status epilepticus, coma or assisted ventilation prior to study enrollment\n* Protocol therapy must begin within 31 calendar days of definitive surgery or clinical diagnosis, whichever is later. If a biopsy only was performed, the biopsy date will be considered the date of definitive surgery. For patients who have a biopsy or incomplete resection at diagnosis followed by additional surgery, the date of the last resection will be considered the date of definitive surgery.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met\n* NEUROCOGNITIVE FUNCTION AND QUALITY OF LIFE ASSESSMENT:\n* English-, Spanish-, or French- speaking\n\n  * Note: Patients who speak a language other than English, Spanish, or French will be allowed to participate in ACNS2021 but will not complete the neurocognitive and quality of life assessments\n* No known history of neurodevelopmental disorder prior to diagnosis of NGGCT (e.g., Down syndrome, fragile X, William syndrome, intellectual disability). Patients with NF1 will be allowed to participate\n* Additional eligibility criteria for the COG Standardized Neuropsychological Battery only: must be at a site that has a psychologist to administer the battery\n\n  * Note: If not eligible for the COG Standardized Battery, patients should still complete the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2), Pediatric Quality of Life Inventory (PedsQL), Adaptive Behavior Assessment System Third Edition (ABAS-3), and Behavior Assessment System for Children, Third Edition (BASC-3) questionnaires\n\nExclusion Criteria:\n\n* Patients with tumors located outside the ventricles (i.e., basal ganglia, thalamus)\n* Patients with only mature teratoma and non-elevated markers upon tumor sampling at diagnosis\n* Patients who have received any prior tumor-directed therapy for their diagnosis of NGGCT other than surgical intervention and corticosteroids\n* Patients with metastatic disease (i.e., MRI evaluation, lumbar CSF cytology or intraoperative evidence of dissemination)\n* Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs\n\n  * Note: Serum and urine pregnancy tests may be falsely positive due to HCGbeta-secreting germ cell tumors. Ensure the patient is not pregnant by institutional standards\n* Lactating females who plan to breastfeed their infants\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation","3 Years","29 Years",{"count":422,"type":22},160,[25],"This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT.",[426,427,428,429,430,431,432,433,434,435],"Central Nervous System Nongerminomatous Germ Cell Tumor","Choriocarcinoma","Embryonal Carcinoma","Immature Teratoma","Malignant Teratoma","Mixed Germ Cell Tumor","Pineal Region Germ Cell Tumor","Pineal Region Immature Teratoma","Pineal Region Yolk Sac Tumor","Suprasellar Germ Cell Tumor",{"date":39,"type":40},{"date":438,"type":40},"2021-07-13",{"date":440,"type":22},"2029-12-21",{"name":309,"class":310},170,{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":136,"enrollmentInfo":450,"targetDuration":4,"studyType":23,"phases":452,"briefSummary":453,"conditions":454,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":320},"100387252","phase-2-a-study-of-combination-chemotherapy-for-patients-with-newly-diagnosed-dawt-and-relapsed-fhwt-100387252","NCT04322318","A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT","Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)","Inclusion Criteria:\n\n* Patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on APEC14B1, consented to Part A - Eligibility Screening, and have received an initial stratum assignment showing DAWT (if anaplasia first identified at diagnostic, pre-treatment nephrectomy or biopsy) or a final stratum assignment showing DAWT (if anaplasia first noted at delayed nephrectomy) prior to enrollment on AREN1921. Prior enrollment on APEC14B1 is not an eligibility requirement for patients with relapsed favorable histology Wilms tumor.\n* Patients must be =\\\u003C 30 years old at study enrollment\n* Patients with the following diagnoses are eligible for this study:\n\n  * Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor as confirmed by central review\n  * Favorable histology Wilms tumor at first relapse. Relapsed FHWT patients must have previously achieved remission for their initial FHWT diagnosis to be eligible for this study. The relapse risk groups are defined as follows, regardless of radiation therapy:\n\n    * Standard-Risk relapse: Patients who received two chemotherapy agents for frontline therapy; primarily actinomycin D and vincristine\n    * High-Risk relapse: Patients who received three chemotherapy agents for frontline therapy; primarily vincristine, actinomycin D and doxorubicin or vincristine, actinomycin D and irinotecan\n    * Very High-Risk relapse: Patients who received four or more chemotherapy agents as part of initial therapy; primarily regimen M or its variations\n* Patients with newly diagnosed DAWT must have had histologic verification of the malignancy. For relapsed FHWT patients, biopsy to prove recurrence is encouraged, but not required\n\n  * Note: For relapsed FHWT patients, an institutional pathology report confirming favorable histology Wilms tumor (from relapse, if available, or from original diagnosis) must be available for upload prior to initiation of protocol therapy\n* Patients with newly diagnosed Stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on AREN1921 within 2 weeks of the tumor-directed surgery or biopsy procedure that first confirms a diagnosis of DAWT, whether at initial diagnostic procedure or delayed nephrectomy (such surgery\u002Fbiopsy is day 0). For patients who received prior therapy for presumed favorable histology Wilms tumor, later confirmed to have diffuse anaplastic Wilms tumor at subsequent review of the initial biopsy\n* Patients with newly diagnosed DAWT who undergo upfront nephrectomy must have at least 1 lymph node sampled prior to study enrollment\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age\n* Patients must have a life expectancy of \\>= 8 weeks\n* Diffuse Anaplastic Wilms Tumor: Patients with diffuse anaplastic histology must have had no prior systemic therapy, except in the following situations:\n\n  * Patients with diffuse anaplastic Wilms tumor who received no more than 12 weeks of pre nephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor, subsequently confirmed to be diffuse anaplastic Wilms tumor at delayed nephrectomy\n  * Patients with diffuse anaplastic Wilms tumor who received no more than 6 weeks of chemotherapy following upfront biopsy, initiated within 14 days of biopsy, for presumed favorable histology Wilms tumor based on institutional review, but subsequently corrected to diffuse anaplastic Wilms tumor based on the initial stratum assignment on APEC14B1-REN\n  * Treatment consisting of vincristine\u002Fdoxorubicin\u002Fcyclophosphamide initiated on an emergent basis and within allowed timing as described\n  * Note: Patients who received prior therapy for presumed favorable histology Wilms tumor, later identified to have diffuse anaplastic Wilms tumor as per above, must begin study treatment starting at cycle 3 (week 7) of regimen UH 3. Patients who received emergency radiation to preserve organ function are eligible as noted. Patients who received radiation as part of standard of care for presumed newly diagnosed favorable histology Wilms tumor, along with chemotherapy as noted above, prior to identification of diffuse anaplasia, are also eligible\n* Relapsed Favorable Histology Wilms Tumor: Patients must not have received prior chemotherapy for their relapsed favorable histology Wilms tumor diagnosis. In addition, patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\n\n  * Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study\n  * Radiation therapy (RT): \\>= 2 weeks (wks) must have elapsed for local palliative RT (small port); \\>= 6 months must have elapsed if prior craniospinal RT or if \\>= 50% radiation of pelvis; \\>= 6 wks must have elapsed if other substantial bone marrow (BM) radiation. Patients with relapsed favorable histology Wilms tumor who received emergency radiation to preserve organ function are eligible and do not need to washout with the above criteria\n* Patients may not be receiving any other investigational agents (within 4 weeks prior to study enrollment)\n* Peripheral absolute neutrophil count (ANC) \\>= 750\u002FuL (performed within 7 days prior to enrollment)\n* Platelet count \\>= 75,000\u002FuL (transfusion independent) (performed within 7 days prior to enrollment)\n* Hemoglobin \\>= 8.0 g\u002FdL (may receive red blood cell \\[RBC\\] transfusions) (performed within 7 days prior to enrollment)\n* Patients with high-risk or very high-risk relapsed FHWT who will be treated with regimen ICE\u002FCyclo\u002FTopo, must have renal function assessed by creatinine clearance or radioisotope glomerular filtration rate (GFR) and meet the following requirement:\n\n  * Creatinine clearance or radioisotope GFR \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 (performed within 7 days prior to enrollment)\n* Patients diagnosed with stage 2-4 DAWT or standard risk relapsed FHWT, who will be treated with regimen UH 3, may either obtain a creatinine clearance, radioisotope GFR (meeting the above criteria of GFR \\>= 60 mL\u002Fmin\u002F1.73 m\\^2), or an adequate serum creatinine as per the following table:\n\n  * Age: Maximum Serum Creatinine (mg\u002FdL)\n  * 1 month to \\\u003C 6 months: 0.4 (male and female)\n  * 6 months to \\\u003C 1 year: 0.5 (male and female)\n  * 1 to \\\u003C 2 years: 0.6 (male and female)\n  * 2 to \\\u003C 6 years: 0.8 (male and female)\n  * 6 to \\\u003C 10 years: 1 (male and female)\n  * 10 to \\\u003C 13 years: 1.2 (male and female)\n  * 13 to \\\u003C 16 years: 1.5 (male), 1.4 (female)\n  * \\>= 16 years: 1.7 (male), 1.4 (female)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) for age or direct bilirubin =\\\u003C ULN for patients whose total bilirubin \\> 1.5 x ULN (performed within 7 days prior to enrollment)\n* Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \\[AST\\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) \\\u003C 2.5 x upper limit of normal (ULN) for age or =\\\u003C 5 x ULN for patients with liver metastases (performed within 7 days prior to enrollment)\n* Shortening fraction of \\>= 27% by echocardiogram, or ejection fraction of \\>= 50% by radionuclide angiogram (obtained within 21 days prior to enrollment and start of protocol therapy)\n\nExclusion Criteria:\n\n* Patients with a history of bilateral Wilms tumor (synchronous or metachronous)\n* Patients with any uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, or symptomatic congestive heart failure (defined as grade 2 or higher heart failure per Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5.0)\n* Relapsed FHWT patients who did not receive frontline chemotherapy (e.g., very low risk FHWT initially observed without chemotherapy) or received only one chemotherapy agent for frontline therapy\n* For patients with high-risk or very high-risk relapsed FHWT:\n\n  * Patients with renal tubular acidosis (RTA) as evidenced by serum bicarbonate \\\u003C 16 mmol\u002FL and serum phosphate =\\\u003C 2 mg\u002FdL (or \\\u003C 0.8 mmol\u002FL) without supplementation\n* For stages 2-4 DAWT and standard-risk relapsed FHWT patients:\n\n  * Chronic inflammatory bowel disease and\u002For bowel obstruction\n  * Concomitant use of St. John's wort, which cannot be stopped prior to the start of trial treatment\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential\n* Lactating females who plan to breastfeed their infants\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation",{"count":451,"type":22},256,[25],"This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE\u002FCyclo\u002FTopo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out what effects, good and\u002For bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE\u002FCyclo\u002FTopo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).",[455,456,457,458,459],"Anaplastic Kidney Wilms Tumor","Recurrent Kidney Wilms Tumor","Stage II Kidney Wilms Tumor","Stage III Kidney Wilms Tumor","Stage IV Kidney Wilms Tumor",{"date":39,"type":40},{"date":462,"type":40},"2020-10-19",{"date":464,"type":22},"2027-07-01",{"name":309,"class":310},{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":17,"minAge":473,"maxAge":474,"enrollmentInfo":475,"targetDuration":4,"studyType":23,"phases":477,"briefSummary":478,"conditions":479,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":490},"100359362","phase-3-inotuzumab-ozogamicin-and-post-induction-chemotherapy-in-treating-patients-with-high-risk-b-all-mixed-phenotype-acute-leukemia-and-b-lly-100359362","NCT03959085","Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy","A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy","Inclusion Criteria:\n\n* B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 22 days of enrollment for suspected MPAL patients. If not performed within this time frame, patients will be taken off protocol.\n* APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732.\n* Patients must be \\> 365 days and \\\u003C 25 years of age\n* Initial white blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy):\n\n  * Age 1-9.99 years: WBC \\>= 50,000\u002FuL\n  * Age 10-24.99 years: Any WBC\n  * Age 1-9.99 years: WBC \\\u003C 50,000\u002FuL with one or more of the following:\n\n    * Testicular leukemia\n    * CNS leukemia (CNS3)\n    * Steroid pretreatment.\n* Initial white blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy):\n\n  * Age 1-24.99 years: any WBC NOTE: Patients enrolled as suspected MPAL but found on central confirmatory testing to have B-ALL must meet the B-ALL criteria above (age, WBC, extramedullary disease, steroid pretreatment) to switch to the B-ALL stratum before the end of induction.\n* Patient has newly diagnosed B-ALL or MPAL (by World Health Organization \\[WHO\\] 2016 criteria) with \\>= 25% blasts on a bone marrow (BM) aspirate;\n\n  * OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy;\n  * OR A complete blood count (CBC) documenting the presence of at least 1,000\u002FuL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed.\n* Patient has newly diagnosed B-LLy Murphy stages III or IV.\n* Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment.\n* Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e., paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted.\n* Central nervous system (CNS) status must be determined prior to enrollment based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment and cytoreduction. Note that once cerebrospinal fluid (CSF) has been collected, protocol therapy can be initiated while final determination of CNS status is pending. It is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. This is allowed prior to enrollment. Systemic chemotherapy must begin within 72 hours of this intrathecal therapy.\n* Direct bilirubin \\\u003C 2.0 mg\u002FdL (34 micromoles\u002FL)\n* Alanine aminotransferase (ALT) ≤ 10x upper limit of normal (ULN). For the purposes of this study, the ULN for ALT is defined as 45 U\u002FL\n* Exceptions to this include patients with known Gilbert's Syndrome, or those with hepatic involvement from leukemic or lymphomatous infiltration\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met.\n\nExclusion Criteria:\n\n* Patients with Down syndrome are not eligible\n* With the exception of steroid pretreatment and steroid cytoreduction or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732.\n* Patients who have received \\> 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy.\n* Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing \\> 1,000\u002FuL circulating leukemia cells.\n* Patients with acute undifferentiated leukemia (AUL) are not eligible.\n* For Murphy stage III\u002FIV B-LLy patients, or stage I\u002FII patients with steroid pretreatment, the following additional exclusion criteria apply:\n\n  * T-lymphoblastic lymphoma.\n  * Morphologically unclassifiable lymphoma.\n  * Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma.\n* Patients with known Charcot-Marie-Tooth disease.\n* Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype.\n* Patients requiring radiation at diagnosis.\n* Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.\n* Lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation. For those patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the last dose of inotuzumab ozogamicin for females and 5 months after the last dose of inotuzumab ozogamicin for males.","365 Days","25 Years",{"count":476,"type":22},5951,[60],"This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy and immunotherapy (chemo-immunotherapy) for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. Inotuzumab ozogamicin is a monoclonal antibody, which is a type of protein that can bind to certain targets on the surface of cells. Inotuzumab ozogamicin is a monoclonal antibody that is linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells by binding to the CD22 protein on the surface of the cancer cell and delivering calicheamicin inside the cells to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Blinatumomab is a specialized type of monoclonal antibody known as a bispecific T-cell engager (BiTE). It works by simultaneously binding to CD19 on cancer cells and CD3 on normal immune cells, bringing them together to destroy leukemia cells. Blinatumomab is a standard part of chemo-immunotherapy treatment for B-ALL. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin or blinatumomab.\n\nThe overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemo-immunotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first phase of therapy: Induction. This part will collect information on the leukemia, as well as the effects of the initial treatment, to classify patients into post-induction treatment groups. On the second part of this study, patients with HR B-ALL will receive the remainder of the chemotherapy cycles (consolidation, blinatumomab block 1, interim maintenance 1, blinatumomab block 2, delayed intensification, interim maintenance 2, maintenance), with some patients randomized to receive inotuzumab. The patients that receive inotuzumab will not receive part of consolidation or part of delayed intensification. Other aims of this study include evaluating 1) side effects of treatment using patient-reported outcomes and health-related quality of life, 2) the best ways to help patients adhere to oral chemotherapy regimens, 3) the relationship between levels of inotuzumab ozogamicin in the blood and side effects, 4) the impact of chemo-immunotherapy on the immune system and risk of infection, and 5) the impact of social determinants of health on outcomes. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.",[480,481,482,401,483],"B Acute Lymphoblastic Leukemia","B Lymphoblastic Lymphoma","Central Nervous System Leukemia","Testicular Leukemia",{"date":39,"type":40},{"date":486,"type":40},"2019-10-31",{"date":488,"type":22},"2032-03-31",{"name":309,"class":310},231,{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":23,"phases":500,"briefSummary":501,"conditions":502,"keywords":505,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":517},"100323125","phase-3-long-term-safety-and-efficacy-extension-study-for-participants-with-advanced-tumors-who-are-currently-on-treatment-or-in-follow-up-in-a-pembrolizumab-mk-3475-study-mk-3475-587keynote-587-100323125","NCT03486873","Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587\u002FKEYNOTE-587)","A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab","Inclusion Criteria:\n\n* Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.\n* Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.\n\nAdditional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:\n\n* Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Demonstrates adequate organ function.\n* Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of \\>30 Gray (Gy), they must have recovered from the toxicity and\u002For complications of the intervention.\n* A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.\n\nAdditional eligibility criteria for participants who enter dosing with Lenvatinib:\n\n* Adequately controlled blood pressure (BP) to \\\u003C150\u002F90 mmHg, with or without antihypertensive medications.\n* For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.\n* Is female and not pregnant\u002Fbreastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.\n\nExclusion Criteria:\n\n-There are no exclusion criteria to participate in MK-3475-587.\n\nParticipants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:\n\n* Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.\n* Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has a known history of human immunodeficiency virus (HIV) infection.\n* Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.\n* Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.\n* Has hepatic decompensation (Child-Pugh score \\>6 \\[class B and C\\]).\n* Has uncontrolled thyroid dysfunction.\n* Has uncontrolled diabetes mellitus.\n* Has had an allogeneic tissue\u002Fsolid organ transplant.\n* Has a known history of active tuberculosis (TB; Bacillus tuberculosis).\n\nAdditional exclusion criteria for participants who enter dosing with Lenvatinib:\n\n* Has had major surgery within 3 weeks prior to first dose of study intervention(s).\n* Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.\n* Has urine protein ≥1 g\u002F24 hours.\n* Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).\n* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.\n* Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \\>480 ms.\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.\n* Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.\n* Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.\n* Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.",{"count":499,"type":22},3500,[60],"The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.\n\nThis study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.\n\nAny participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.",[503,504],"Solid Tumors","Hematologic Malignancies",[506,507,508,509],"PD1","PD-1","PDL1","PD-L1",{"date":39,"type":40},{"date":512,"type":40},"2018-08-21",{"date":514,"type":22},"2043-08-04",{"name":516,"class":47},"Merck Sharp & Dohme LLC",782,{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":525,"targetDuration":4,"studyType":23,"phases":527,"briefSummary":528,"conditions":529,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":564,"locationsCount":565},"100290931","phase-3-active-surveillance-bleomycin-etoposide-carboplatin-or-cisplatin-in-treating-pediatric-and-adult-patients-with-germ-cell-tumors-100290931","NCT03067181","Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors","A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors","Inclusion Criteria:\n\n* There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT \\[all sites\\])\n* Standard risk 1: Patients must be \\\u003C 11 years of age at enrollment\n* Standard risk 2: Patients must be \\>= 11 and \\\u003C 25 years of age at enrollment\n* Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with malignant germ cell tumor (stage II or higher).\n\n  * Histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment , with the following exceptions:\n\n    * Among patients were initially diagnosed with completely resected non-seminoma malignant GCT and later recur during observation post surgery, a diagnostic biopsy is not required for enrollment if elevated tumor markers rise to \\> 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart. The pathology report of initial surgery should be provided\n    * Patients may be enrolled without histologic or cytologic confirmation in the rare case where there are exceptionally raised tumor markers (alpha fetoprotein \\[AFP- ≥ 500 ng\u002FmL or HCG ≥ 500 IU\u002FL) and radiologic features consistent with GCT. In addition, the treating clinician must deem that the patient's tumor is not suitable for upfront resection and that a biopsy is not in the patient's best interest; or that there is a need to start therapy urgently\n* Low risk immature teratoma (IT); site: ovarian; stage: any; grade: any; histology: pure immature teratoma, mixed immature and mature teratoma, (may contain microscopic foci of yolk sac tumor \\[\\\u003C 3 mm\\], but no other pathological evidence of MGCT); tumor markers: alpha-FP =\\\u003C 1,000 ng\u002FmL, beta-HCG institutional normal; all ages\n* Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages\n* Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain only seminoma; may contain immature\u002Fmature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages\n* Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC-IV, (International Germ Cell Consensus Classification \\[IGCCC\\] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \\\u003C 11\n* Standard risk 2 (SR2)\n\n  * Site: ovarian; stage: COG stage II, III, and III-X, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \\>= 11 and \\\u003C 25\n  * Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma: must be IGCCC good risk; post op: alpha-FP \\\u003C 1,000 ng\u002FmL, beta-HCG \\\u003C 5,000 IU\u002FmL and lactate dehydrogenase (LDH) \\\u003C 3.0 x normal; age (years) \\>= 11 and \\\u003C 25\n* Notes:\n\n  * IGCCC criteria only apply to SR2 patients with a testicular primary tumor\n  * Use post-op tumor marker levels to determine IGCCC risk group\n  * Pure seminoma patients are not eligible for the standard risk arms of the study\n  * For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a \"microscopic component\" of yolk sac tumor\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age\n* Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients)\n* Adequate renal function defined as:\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 (within 7 days prior to enrollment) OR\n* A serum creatinine based on age\u002Fsex as follows (within 7 days prior to enrollment): (mg\u002FdL)\n\n  * 1 month to \\\u003C 6 months male: 0.4 female: 0.4\n  * 6 months to \\\u003C 1 year male: 0.5 female: 0.5\n  * 1 to \\\u003C 2 years male: 0.6 female: 0.6\n  * 2 to \\\u003C 6 years male: 0.8 female: 0.8\n  * 6 to \\\u003C 10 years male: 1 female: 1\n  * 10 to \\\u003C 13 years male: 1.2 female: 1.2\n  * 13 to \\\u003C 16 years: male: 1.5 female: 1.4\n  * \\>= 16 years male: 1.7 female: 1.4\n* Total bilirubin =\\\u003C 2 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)\n\n  * Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x upper limit of normal (ULN) (within 7 days prior to enrollment)\n\n  * Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome\n* Peripheral absolute neutrophil count (ANC) \\>= 750\u002Fmm\\^3 (within 7 days prior to enrollment) AND\n* Platelet count \\>= 75,000\u002Fmm\\^3 (within 7 days prior to enrollment)\n* Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment\n* Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes \\[PROs\\] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate\n* \\>= 11 and \\\u003C 25 years old at enrollment\n* Able to fluently speak and read English\n* Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor\n* Followed for cancer or survivorship care at one of the following institutions:\n\n  * Baylor College of Medicine\u002FDan L Duncan Comprehensive Cancer Center\n  * Dana Farber\u002FHarvard Cancer Center\n  * Hospital for Sick Children\n  * Children's Hospital of Eastern Ontario\n  * Oregon Health and Science University\n  * Seattle Children's Hospital\n  * Yale University\n\nExclusion Criteria:\n\n* Patients with any diagnoses not listed including:\n\n  * Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)\n  * Pure ovarian or extragonadal dysgerminoma\u002Fseminoma\n  * Pure mature teratoma\n  * Pure immature teratoma with alpha-fetoprotein (AFP) \\>= 1000 ng\u002FmL\n  * \"Poor risk\" GCT (age \\>= 11 years old and COG stage IV ovarian, COG stage II- IV extragonadal, or IGCCC intermediate or poor risk testicular), or\n  * Primary central nervous system (CNS) germ cell tumor\n  * Germ cell tumor with somatic malignant transformation\n  * Spermatocytic seminoma\n* Patients must have had no prior systemic therapy for the current cancer diagnosis\n* Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain \\[stage IV disease\\] would be considered poor risk and therefore not eligible for this trial)\n* Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential; (this criteria applies ONLY to patients who will receive chemotherapy \\[SR1 and SR2 patients\\])\n* Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy \\[SR1 and SR2 patients\\])\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy \\[SR1 and SR2 patients\\])",{"count":526,"type":22},1780,[60],"This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.",[530,531,532,533,534,535,536,537,538,539,540,541,542,543,544,545,546,547,548,549,550,551,552,553,554,555,556,557,558,559],"Childhood Extracranial Germ Cell Tumor","Extragonadal Embryonal Carcinoma","Germ Cell Tumor","Malignant Germ Cell Tumor","Malignant Ovarian Teratoma","Stage I Ovarian Choriocarcinoma","Stage I Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7","Stage I Testicular Choriocarcinoma AJCC v6 and v7","Stage I Testicular Embryonal Carcinoma AJCC v6 and v7","Stage I Testicular Seminoma AJCC v6 and v7","Stage I Testicular Yolk Sac Tumor AJCC v6 and v7","Stage II Ovarian Choriocarcinoma","Stage II Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7","Stage II Testicular Choriocarcinoma AJCC v6 and v7","Stage II Testicular Embryonal Carcinoma AJCC v6 and v7","Stage II Testicular Yolk Sac Tumor AJCC v6 and v7","Stage III Ovarian Choriocarcinoma","Stage III Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7","Stage III Testicular Choriocarcinoma AJCC v6 and v7","Stage III Testicular Embryonal Carcinoma AJCC v6 and v7","Stage III Testicular Yolk Sac Tumor AJCC v6 and v7","Stage IV Ovarian Choriocarcinoma","Stage IV Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7","Testicular Mixed Choriocarcinoma and Embryonal Carcinoma","Testicular Mixed Choriocarcinoma and Teratoma","Testicular Mixed Choriocarcinoma and Yolk Sac Tumor",{"date":39,"type":40},{"date":562,"type":40},"2017-05-25",{"date":174,"type":22},{"name":309,"class":310},629,{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":474,"enrollmentInfo":573,"targetDuration":4,"studyType":575,"phases":4,"briefSummary":576,"conditions":577,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":596,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":600,"locationsCount":601},"100239986","project-every-child-for-younger-patients-with-cancer-100239986","NCT02402244","Project: Every Child for Younger Patients With Cancer","The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study","Inclusion Criteria:\n\n* Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem\n* Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority\n* Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows:\n\n  * All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of one \"1\" (borderline), two \"2\" (carcinoma in situ) or three \"3\" (malignant)\n  * All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant\n  * All neoplastic lesions of the kidney regardless of behavior, i.e., benign, borderline or malignant\n  * The following other benign\u002Fborderline conditions:\n\n    * Mesoblastic nephroma\n    * Teratomas (mature and immature types)\n    * Myeloproliferative diseases including transient myeloproliferative disease\n    * Langerhans cell histiocytosis\n    * Lymphoproliferative diseases\n    * Desmoid tumors\n    * Gonadal stromal cell tumors\n    * Neuroendocrine tumors including pheochromocytoma\n    * Melanocytic tumors, except clearly benign nevi\n    * Ganglioneuromas\n* Subjects must be =\\\u003C 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network \\[NCTN\\]) therapeutic study, for which there is a higher upper age limit\n* All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study; parents will be asked to sign a separate consent for their own biospecimen submission\n\n  * If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow; consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1",{"count":574,"type":22},75000,"OBSERVATIONAL","This study gathers health information for the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.",[578,579,580,581,582,583,584,585,586,587,588,589,590,591,592,593,594,595],"Adrenal Gland Pheochromocytoma","Carcinoma In Situ","Central Nervous System Neoplasm","Childhood Immature Teratoma","Childhood Kidney Neoplasm","Childhood Langerhans Cell Histiocytosis","Childhood Mature Teratoma","Congenital Mesoblastic Nephroma","Desmoid Fibromatosis","Ganglioneuroma","Lymphoproliferative Disorder","Malignant Neoplasm","Malignant Solid Neoplasm","Melanocytic Neoplasm","Myeloproliferative Neoplasm","Neoplasm of Uncertain Malignant Potential","Neuroendocrine Neoplasm","Stromal Neoplasm",{"date":39,"type":40},{"date":598,"type":40},"2015-11-03",{"date":409,"type":22},{"name":309,"class":310},279,{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":609,"targetDuration":4,"studyType":23,"phases":611,"briefSummary":612,"conditions":613,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":617,"completionDateStruct":618,"leadSponsor":620,"locationsCount":622},"100651033","a-study-to-test-whether-survodutide-helps-people-with-type-2-diabetes-control-their-blood-sugar-100651033","NCT07754461","A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar","A Phase III, Randomised, Double-blind, Parallel-group, 56-week Study, Evaluating the Efficacy and Safety of Survodutide (BI 456906), Compared With Placebo, in Participants With Type 2 Diabetes, as an Adjunct to Diet and Physical Activity Alone or in Combination With Either Oral Antidiabetic Medications or Insulin","Inclusion criteria:\n\n1. Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \\>18 years\n2. Diagnosed with type 2 diabetes mellitus (T2D) (e.g. American diabetes association (ADA)\u002FEuropean association for the study of diabetes (EASD) guidelines) and must meet requirements for one of background therapy parts A, B or C:\n\n   1. Part A: Naïve to insulin therapy and have not used oral or injectable anti-hyperglycaemic (diabetes) medication for at least 90 days prior to screening (Visit 1) and glycosylated haemoglobin A1c (HbA1c) ≥7.0 (≥53 mmol\u002Fmol) and \\\u003C9.5% (\\\u003C80 mmol\u002Fmol) as measured by the central laboratory at screening (Visit 1);\n   2. Part B: Treated with stable dose of oral antidiabetic medication (OAD) for 90 days prior to screening (Visit 1) as monotherapy or combination of: Maximum tolerated dose of metformin and\u002For Maximum tolerated dose of sulfonylurea and\u002For Maximum tolerated dose of sodium-glucose cotransporter 2 inhibitor (SGLT2i) and HbA1c ≥7.0% (≥53 mmol\u002Fmol) and \\\u003C10.5% (\\\u003C91 mmol\u002Fmol) as measured by the central laboratory at screening (Visit 1);\n   3. Part C: Stable use of basal insulin at a dose of ≥20 international units (IU)\u002Fday with or without stable dose of metformin and\u002For SGLT2i for 90 days prior to screening (Visit 1) and HbA1c ≥7.0% (≥53 mmol\u002Fmol) and \\\u003C10.5% (\\\u003C91 mmol\u002Fmol) as measured by the central laboratory at screening (Visit 1)\n3. Body mass index (BMI) ≥23 kg\u002Fm2 at screening (Visit 1)\n4. Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial\n5. Woman (or women) of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per international council for harmonisation of technical requirements for pharmaceuticals for human use M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.\n6. In the investigator's opinion, participants are well-motivated, capable, and willing to: Learn how to self-inject the investigational medicinal product (IMP), as required for this protocol (persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IMP); Inject the IMP or accept injection from a designated person; Follow study procedures for the duration of the study, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and exercise plan), maintain a diary, complete required questionnaires, and handle the IMP as described in the instructions for use (IFU)\n\nExclusion criteria:\n\n1. Type 1 diabetes mellitus (T1D) or latent autoimmune diabetes in adults (LADA)\n2. Treatment within 90 days before screening (Visit 1) up to and including randomisation (Visit 2) with any: glucagon-like peptide-1 receptor (GLP-1R) agonists including GLP-1R agonist\u002Fglucose-dependent insulinotropic polypeptide (GIP) combinations, amylin or incretin combinations; Glucose-lowering drugs other than stated in the inclusion criteria for each part (i.e. metformin, Sodium-Glucose Cotransporter 2 Inhibitor (SGLT2i), basal insulin, depending on the background therapy part); Glucose-lowering investigational drug; Any anti-obesity medication including bupropion\u002Fnaltrexone, orlistat, phentermine, and phentermine\u002Ftopiramate\n3. History of ketoacidosis or hyperosmolar state or coma within the last 6 months before screening (Visit 1) up to and including randomisation (Visit 2)\n4. Hypoglycaemia unawareness or a history of severe hypoglycaemia within the last 3 months before screening (Visit 1) up to and including randomisation (Visit 2)\n5. Diabetic retinopathy or maculopathy currently under treatment, or that is reasonably anticipated to require such treatment over the duration of the study\n6. Body weight change (self-reported) \\>5% within 90 days before screening (Visit 1)\n7. Previous or planned (during the trial period) treatment for obesity with surgery or a weight loss device, including any prior bariatric surgery. The following are allowed: (1) liposuction and\u002For abdominoplasty, if performed \\>1 year before screening (Visit 1), (2) lap banding, if the band has been removed \\>1 year before screening (Visit 1), (3) intragastric balloon, if the balloon has been removed \\>1 year before screening (Visit 1), (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \\>1 year before screening (Visit 1).\n8. Answered \"yes\" to any of the suicide-related behaviours (Actual attempt, Interrupted attempt, Aborted attempt, Preparatory act or behaviour) or to the non-suicidal self-injurious behaviour question on the \"Suicidal Behaviour\" section of the Columbia-Suicide Severity Rating Scale (C-SSRS) related to the past 2 years before screening (Visit 1) up to and including randomisation (Visit 2)\n9. Further exclusion criteria apply.",{"count":610,"type":22},600,[60],"This study aims to find out whether a study medicine called survodutide helps people control their blood sugar. Adults who live with type 2 diabetes and with a body mass index (BMI) of 23 kg\u002Fm2 or higher can join.\n\nThe study has 3 parts. In each part the study compares survodutide with placebo. Survodutide is being developed to treat several health problems including type 2 diabetes. Placebo looks like survodutide but does not contain any medicine.\n\nDepending on a person's diabetes treatment, a person will be assigned either to\n\n* Part A: healthy eating and physical activity\n* Part B: diabetes tablets (no injection of insulin)\n* Part C: injection of insulin (with or without diabetes tablets)\n\nParticipants are randomly put into 1 of 3 groups, which means the group is chosen by chance. Two groups of participants get survodutide at different dose levels, and the third group gets placebo as injection under the skin once a week. You have a 2 in 3 chance of getting survodutide. During the study, participants continue their regular diabetes treatment.\n\nParticipants are in the study for about 1 year and 2 months. During this time, they attend up to 12 visits at the site and receive at least 9 phone calls. Study doctors regularly test participants' blood sugar by checking their HbA1c values and other laboratory test results. The study doctor also regularly checks participants' health and takes note of any changes. For each study part, the results will be compared between the survodutide and the placebo group to see whether the treatment works.",[614],"Type 2 Diabetes","2026-08-20",{"date":199,"type":40},{"date":37,"type":22},{"date":619,"type":22},"2028-05-01",{"name":621,"class":47},"Boehringer Ingelheim",120,{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":630,"targetDuration":4,"studyType":23,"phases":631,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":636,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":642},"100624094","extension-study-for-participants-in-studies-that-include-belzutifan-mk-6482-043litespark-043-100624094","NCT07405164","Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043\u002FLITESPARK-043)","A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long-term Efficacy and Safety in Participants Who Are Currently on Treatment in a Belzutifan Study (LITESPARK-043)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Participants with advanced solid tumors or von Hippel-Lindau-related neoplasms who are participating in belzutifan-containing studies and on active treatment in a belzutifan parent study.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has an on-going serious adverse event in the parent study, unless no longer hospitalized and considered clinically stable.\n* Is currently on a dose interruption due to an Adverse Event (AE) in the parent study; once treatment has been resumed in the parent study, the participant is eligible to enroll.",{"count":58,"type":22},[60],"Researchers are looking for new ways to treat advanced solid tumors and von Hippel-Lindau (VHL)-related tumors:\n\n* Advanced means the cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery\n* Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids\n* VHL-related tumors are tumors caused by VHL disease. VHL disease is passed down from parents to children and people with VHL disease have a higher chance of getting certain types of cancer\n\nResearchers want to learn about the long-term effects of a trial medicine called belzutifan. Belzutifan, also called MK-6482, is designed to block a protein that helps tumors grow and survive. This is an extension trial, which means only people who were in certain other belzutifan trials (called parent trials) may be able to join. The goal of this trial is to learn how long people live after they start taking belzutifan.",[634,635],"Von Hippel-Lindau Disease","Malignant Neoplasms",{"date":37,"type":40},{"date":638,"type":40},"2026-03-23",{"date":640,"type":22},"2034-01-14",{"name":516,"class":47},51,{"id":644,"slug":645,"hasResults":12,"nctId":646,"briefTitle":647,"officialTitle":648,"acronym":4,"eligibilityCriteria":649,"healthyVolunteers":650,"sex":17,"minAge":18,"maxAge":215,"enrollmentInfo":651,"targetDuration":4,"studyType":23,"phases":653,"briefSummary":654,"conditions":655,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":657,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":662,"locationsCount":664},"100613830","phase-1-a-study-to-determine-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-ro7806881-in-healthy-participants-100613830","NCT07271693","A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants","A Phase I, Randomized, Investigator\u002FParticipant-blind, Parallel-group, Placebo-controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants","Inclusion Criteria:\n\n* Participants must be males or females who are overtly healthy as determined by medical evaluation\n* Participants must have body weight (BW) ≥ 40 kilograms (kg) (not applicable to Cohort A9) and body mass index (BMI) within the range 18-32 kilograms per square meter (kg\u002Fm\\^2) (inclusive)\n\nInclusion Criteria Specific to Cohort A9 (East Asian Cohort):\n\n* Must be of ethnic Chinese, Korean, or Japanese origin\n* Must have a BW \\>35 kg and BMI within the range 18-32 kg\u002Fm2 (inclusive)\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding, or intention to become pregnant during the study or within 6 months after the final dose of study treatment\n* History of any clinically significant autoimmune, gastrointestinal, renal, hepatic, pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, or allergic disease; metabolic disorder; cancer or cirrhosis\n* Latent tuberculosis (TB) or potentially active TB\n* Any major illness within 1 month before the screening examination or any febrile illness within 1 week prior to the screening visit and up to first dose administration\n* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study\n* History of hypersensitivity to biologic agents or any of the excipients in the formulation, or other allergy that contraindicates participation in the study\n* Live vaccines within 1 month of the first screening visit or during the screening period\n* Non-live vaccines within 2 weeks prior to dosing\n* Previous exposure to RO7806881\n* Positive hepatitis C virus (HCV) antibody test result\n* Positive test results for hepatitis B infection\n* Positive human immunodeficiency virus (HIV) antibody test result\n* Positive test result consistent with cytomegalovirus (CMV) or Epstein-Barr virus (EBV)",true,{"count":652,"type":22},128,[166],"The main purpose of this study is to evaluate the safety and tolerability of single and multiple ascending doses of RO7806881 in healthy participants.",[656],"Healthy Volunteers",{"date":199,"type":40},{"date":659,"type":40},"2025-12-22",{"date":661,"type":22},"2027-03-01",{"name":663,"class":47},"Hoffmann-La Roche",1,{"id":666,"slug":667,"hasResults":12,"nctId":668,"briefTitle":669,"officialTitle":670,"acronym":671,"eligibilityCriteria":672,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":673,"targetDuration":4,"studyType":23,"phases":675,"briefSummary":676,"conditions":677,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":679,"startDateStruct":680,"completionDateStruct":682,"leadSponsor":684,"locationsCount":685},"100609703","a-clinical-study-of-sotatercept-mk-7962-in-people-with-pulmonary-arterial-hypertension-mk-7962-038-100609703","NCT07218029","A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)","An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)","SOTERIA","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early\n* Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements\n* Must have the ability to understand and provide documented informed consent\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Did not participate in a sotatercept PAH parent study\n* Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.\n* Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept\n* Is a female who is pregnant or breastfeeding\n* Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study\n* Is currently enrolled in another investigational product study other than a sotatercept study\n* Is incapacitated",{"count":674,"type":22},815,[60],"Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse.\n\nSotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH.\n\nThis is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.",[678],"Pulmonary Arterial Hypertension",{"date":199,"type":40},{"date":681,"type":40},"2021-05-12",{"date":683,"type":22},"2028-12-07",{"name":516,"class":47},134,""]