[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Canada\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":690},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,4265,0,25,[9,55,87,110,138,174,202,226,258,283,310,339,360,387,412,439,472,500,528,559,584,607,628,648,668],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100630823","phase-2-a-study-of-bms-986504-monotherapy-and-in-combination-with-other-agents-in-participants-with-advanced-andor-metastatic-solid-tumors-with-homozygous-mtap-deletion-mountaintap-5-100630823",false,"NCT07492680","A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and\u002For Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)","A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and\u002For Metastatic Solid Tumors With Homozygous MTAP Deletion","Inclusion Criteria:\n\n* Participant must have histologically confirmed diagnosis of advanced and\u002For metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.\n* Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease.\n* Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline.\n* Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer must be ≤ 2 × ULN.\n* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor.\n* Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).\n* Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications.\n* Participants must not have inadequate organ function, as determined by laboratory testing within the screening period.\n* Participants must not have active viral HBV or HCV hepatitis.\n* Other protocol defined inclusion\u002Fexclusion criteria applies.","ALL","18 Years",{"count":20,"type":21},260,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and\u002For metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.",[27],"Solid Tumors",[29,30,31,32,33,34,35,36,37,38,39,40,41],"MTAP","CDKN2A","PRMT5","MountainTAP","Targeted therapy","Brain cancer","GBM","Melanoma","NSCLC","Lung cancer PDAC","Pancreatic cancer","Navlimetostat","Navli","RECRUITING","2026-08-24",{"date":45,"type":46},"2026-08-25","ACTUAL",{"date":48,"type":46},"2026-07-27",{"date":50,"type":21},"2032-05-20",{"name":52,"class":53},"Bristol-Myers Squibb","INDUSTRY",57,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":12,"sex":17,"minAge":63,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100622055","phase-2-study-to-evaluate-the-pharmacodynamics-safety-and-efficacy-of-sky-0515-in-participants-with-huntingtons-disease-100622055","NCT07378644","Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease","A Phase 2\u002F3 Randomized, Double Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease","FALCON-HD","Inclusion Criteria:\n\n* 25 years or older.\n* Huntington's Disease confirmed through genetic testing, with a specific change in exon 1 of the HTT gene (CAG repeat of 40 or more).\n* Total Functional Capacity (TFC) score of 10 or more).\n* Total Motor Score (TMS) of 6 or more).\n* Independence Score (IS) of 70 or more).\n* Women who can have children must have a negative pregnancy test before starting and use two types of birth control during the study and for 30 days after the last dose of the study drug.\n* Men must agree to use birth control during the study and for 90 days after the last dose.\n* Agree to sign a consent form and follow the study's rules and schedule.\n\nExclusion Criteria:\n\n* Other Serious health problems or brain\u002Fspinal issues that could interfere with the study or make procedures unsafe.\n* Conditions that interfere with protocol-specified assessments, like an implanted medical device or difficulty getting an MRI.\n* Cancer, except for some types of skin cancer, or a history of cancer in the last five years.\n* Severe allergies or have reacted badly to similar drugs in the past.\n* Taking medications or treatments that might interfere with the study.\n* Participated in another study or taken experimental drugs in the last two months (or longer for some drugs).\n* Any kind of gene therapy.\n* History of suicidal thoughts, severe depression, or have attempted suicide in the past year.\n* Liver function tests show significant abnormalities.\n* Positive for hepatitis B, hepatitis C, or HIV.\n* Pregnancy, breastfeeding, or planning to become pregnant during the study.","25 Years",{"count":65,"type":21},400,[24,67],"PHASE3","The goal of this clinical trial is to test if the drug SKY-0515, an oral medication, can lower harmful proteins linked to Huntington's Disease (HD) and improve the symptoms of participants with HD. This study includes men and women aged 25 and older who have HD confirmed by genetic testing and meet certain requirements for physical ability and independence.",[70],"Huntington Disease",[72,73,74,75,70,76,77,78],"SKY-0515","Skyhawk","HTT","Neurodegenerative","mRNA","Splicing","Mutant Huntingtin protein",{"date":45,"type":46},{"date":81,"type":46},"2026-01-06",{"date":83,"type":21},"2029-08",{"name":85,"class":53},"Skyhawk Therapeutics, Inc.",22,{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100617698","phase-3-pridopidine-phase-3-study-to-evaluate-efficacy-and-safety-in-als-100617698","NCT07322003","Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS","A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Amyotrophic Lateral Sclerosis","PREVAiLS","Key Inclusion Criteria:\n\n* Definite ALS or Probable ALS using the El Escorial criteria.\n* Symptom onset of ≤18 months at screening.\n* Slow vital capacity (SVC) greater or equal to 60% predicted.\n* Treatment Research Initiative to Cure ALS (TRICALS) Risk Profile Calculator score, based on the European Network for the Cure of ALS (ENCALS) survival prediction model, in the range of -6 to -2, inclusive, at screening.\n* Able to swallow a capsule.\n\nKey Exclusion Criteria:\n\n* Presence of tracheostomy or permanent assisted ventilation.\n* Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, or presence of left bundle branch block.\n* Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent and participate in the study.\n* Clinically significant and\u002For unstable medical condition (other than ALS) that may either pose a clinically meaningful risk to the participant and\u002For to study completion.\n* Use of medications that prolong QT interval.\n* Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides.\n* Confirmed mutation in the SOD1, FUS or C9orf72 gene.\n* Pregnancy.","80 Years",{"count":97,"type":21},500,[67],"The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults. It will also help to learn about the safety of pridopidine. The main question it aims to answer is:\n\nDoes pridopidine slow disease progression of ALS?\n\nResearchers will compare pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works to treat ALS.\n\nParticipants will:\n\nTake pridopidine or a placebo by mouth every day for 48 weeks. Afterwards, all participants will take pridopidine for another 48 weeks.\n\nVisit the clinic once every 1-3 months for checkups and tests",[101],"Amyotrophic Lateral Sclerosis",{"date":45,"type":46},{"date":104,"type":46},"2026-02-01",{"date":106,"type":21},"2029-03",{"name":108,"class":53},"Prilenia",56,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":17,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100614552","phase-3-a-study-of-nnz-2591-in-pediatric-participants-with-phelan-mcdermid-syndrome-100614552","NCT07281079","A Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome","A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Orally Administered NNZ-2591 Compared With Placebo in Pediatric Participants With Phelan-McDermid Syndrome","Inclusion Criteria:\n\n1. Male or female pediatric participants with Phelan-McDermid syndrome ages 3 to 12 years (inclusive) at the time of signing the informed consent.\n2. Clinical diagnosis of Phelan-McDermid syndrome with a documented disease-causing genetic abnormality of SHANK3.\n3. Body weight ≥ 10 kg at Screening.\n4. Participants with a PMSA-S overall score ≥ 3 at the Screening and Baseline visits.\n5. Not actively undergoing regression or loss of skills.\n\nExclusion Criteria:\n\n1. Use of exclusionary medication or unstable treatment regimens of acceptable concomitant medications as required by the protocol.\n2. Current treatment with more than 3 allowable psychotropic medications.\n3. Participants with seizures must be controlled on no more than 2 anticonvulsant medications (not counting rescue medications).\n4. Psychotropic medications or any other medication used for a chronic illness (not including antibiotics, pain relievers, anti-diarrheals, and laxatives) with doses and dosing regimen that have not been stable for at least 4 weeks before Screening. If the treatment was discontinued, the discontinuation must have occurred no fewer than 2 weeks before the start of Screening.\n5. Any intercurrent seizures in the past 6 months and \u002For more than 1 seizure in the past 12 months. •A single febrile seizure in the 6 months prior to screening is allowable if no rescue medication was required.\n6. Abnormal liver function laboratory results during the Screening period, as defined by the protocol\n7. Abnormal QT interval on Screening ECG as defined by the protocol.","3 Years","12 Years",{"count":120,"type":21},160,[67],"This Phase 3, randomized, double-blind, parallel-group (2-arm), placebo-controlled, multicenter study will evaluate the efficacy and safety of NNZ-2591 compared to placebo in pediatric participants with Phelan- McDermid Syndrome.",[124],"Phelan-McDermid Syndrome",[126,127,128,129],"Phelan McDermid Syndrome","NEU-2591-PMS-301","NNZ-2591","Neuren",{"date":45,"type":46},{"date":132,"type":46},"2025-11-12",{"date":134,"type":21},"2027-11-15",{"name":136,"class":53},"Neuren Pharmaceuticals Limited",15,{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":17,"minAge":146,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":173},"100611717","mapt-protocol-fixation-versus-arthroplasty-surgical-treatments-for-early-recovery-after-hip-fracture-faster-hip-100611717","NCT07244211","MAPT Protocol: Fixation Versus Arthroplasty Surgical Treatments for Early Recovery After HIP Fracture (FASTER-HIP)","Musculoskeletal Adaptive Platform Trial (MAPT): Fixation Versus Arthroplasty Surgical Treatments for Early Recovery After HIP Fracture (FASTER-HIP)","FASTER-HIP","Inclusion Criteria:\n\n* 60 years of age or older undergoing surgery due to a minimally displaced femoral neck fracture\n* The patient has a health condition affecting physical mobility.\n* Complete fracture of the femoral neck (AO\u002FOTA 31B) confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging.\n* Minimally displaced fracture that could be, in the judgment of the attending surgeon, managed with either arthroplasty or in situ internal fixation without reduction.\n* Low energy injury mechanism.\n* Surgeons with expertise in internal fixation and total hip arthroplasty or hemiarthroplasty are available to perform surgery.\n\nExclusion Criteria:\n\n* The patient is not clinically suitable for either compared treatment.\n* Expected injury survival of less than 12 months.\n* Terminal illness with expected survival of less than 12 months.\n* Incarceration.\n* Unable to obtain informed consent due to language barriers.\n* Unable to obtain informed consent because the legally authorized representative was unavailable.\n* Problems, in the judgment of the study personnel, with maintaining follow-up with the patient.\n* Currently enrolled in a study or intervention domain that does not permit co-enrollment.\n* Prior enrollment in the specific platform trial intervention domain.\n* Patient or legally authorized representative did not provide informed consent (declined participation).\n* Eligible patient or legally authorized representative was not approached within the screening window (missed participant).\n* Other reasons to exclude the patient, as approved by the data coordinating center.\n* Associated lower extremity injury that prevents post-operative weight-bearing.\n* Retained hardware around the hip that precludes either study treatment.\n* Infection around the hip (soft tissue or bone).\n* Pathologic fracture with a lytic lesion in the femoral neck that precludes internal fixation.\n* Injury did not occur within 21 days of screening.\n* Patient is too ill, in the judgment of the attending surgeon, for internal fixation.\n* Patient is too ill, in the judgment of the attending surgeon, for arthroplasty.","60 Years",{"count":148,"type":21},600,[150],"NA","This study is an intervention domain of the Musculoskeletal Adaptive Platform Trial. The primary goal of this pragmatic, randomized, open-label, comparative effectiveness trial is to evaluate if arthroplasty is superior to internal fixation when used to treat minimally displaced femoral neck fractures in older adults ≥60 years old. We hypothesize that arthroplasty will reduce death, preserve ambulation, increase days alive and out of hospital, and improve health status compared to internal fixation within 4 months and 12 months from randomization.",[153],"Femoral Neck Fractures",[155,156,157,158,159,160,161,162,163,164],"Minimally displaced femoral neck fractures","arthroplasty","hip fractures","femoral fractures","orthopaedic procedures","older adults","patient-centered outcomes","adaptive trial","internal fixation","pragmatic trial",{"date":45,"type":46},{"date":167,"type":46},"2026-01-23",{"date":169,"type":21},"2030-01-31",{"name":171,"class":172},"University of Southern California","OTHER",26,{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":182,"targetDuration":4,"studyType":22,"phases":184,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":201},"100610191","phase-1-an-open-label-study-of-azd0120-in-adults-with-multiple-sclerosis-100610191","NCT07224373","An Open-label Study of AZD0120 in Adults With Multiple Sclerosis","A Phase 1b, Open-label, Multi-center, Randomized Study Evaluating the Safety and Tolerability of AZD0120, an Autologous CD19\u002FBCMA Targeting Chimeric Antigen Receptor T-cells, in Adults With Refractory Relapsing or Progressive Multiple Sclerosis","ZENITH","Participants are eligible to be included in the study only if all of the following criteria apply:\n\nAge\n\n1. Age ≥ 18-years-old to ≤ 60-years-old at the time of consent\n\n   Type of Participant and Disease Characteristics\n2. Written informed consent in accordance with federal, local, and institutional guidelines\n3. Adequate physiological function and reserve at screening\n\n   RMS Cohort Specific Inclusion Criteria\n4. Diagnosis of RMS according to the 2024 McDonald Criteria (Montalban et al 2025) or diagnosis of relapsing, active SPMS according to Lublin et al 2014.\n5. Participants should have an EDSS of ≤ 6.5 at screening.\n6. Evidence of active disease (clinical relapses and MRI activities within 2 years prior to screening), or intolerance, while on a high efficacy disease-modifying therapy for ≥ 6 months.\n\n   PMS Cohort Specific Inclusion Criteria\n7. Diagnosis of PPMS according to the 2024 McDonald Criteria (Montalban et al 2025) or non-relapsing SPMS according to Lublin et al 2014.\n8. Participants must have an EDSS of ≥ 3.0 and ≤ 6.5 at screening.\n9. Inadequate response ≥ 1 heDMT with ≥ 6 months treatment or intolerance.\n\nExclusion Criteria\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Any prior CAR-T or CAR-NK cell exposure.\n2. Underwent splenectomy within 12 months prior to signing the ICF.\n3. Received a solid organ transplant at any time or on an active transplant waiting list.\n4. Prior treatment with autologous hematopoietic stem cell transplantation or total lymphoid irradiation.\n5. Cardiac conditions or any other significant cardiac condition that would present undue risk to the participant in the investigator's opinion:\n6. Any other central nervous system disease including epilepsy, convulsive seizures, organic encephalopathy syndrome, non-MS related paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease or associated movement disorder, psychosis, CNS vasculitis, or any other neurological disease that may impact the ability to evaluate neurotoxicity. History of a seizure disorder even if the seizure disorder is well controlled with anti-epileptics.\n7. Participant has significant psychiatric condition (active or history of).\n8. History of other immune-mediated disease that required continued systemic immunosuppression\u002Fsystemic disease-modifying agents.\n9. Evidence of clinically significant bleeding or active bleeding diathesis within 90 days before screening\n10. History of malignancy or ongoing treatment for prior malignancy.\n11. Inborn error of immunity and\u002For primary immunodeficiency.\n12. Seropositive for HIV or HTLV (including any history of HIV or HTLV).\n13. Active viral (any etiology, HBV, HCV) hepatitis are excluded.\n14. Major surgery within 4 weeks prior to apheresis or lymphodepletion or has surgery planned during the study or within 4 weeks after study treatment administration.\n15. Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment, whichever is longer.\n16. Unwilling or unsafe to proceed with CSF exams based on coagulopathy or anatomy or other considerations in the judgment of the study investigator.\n17. Any contraindications to LP.\n18. Participants not willing, able, or are unsafe to take MRI scans as per protocol.",{"count":183,"type":21},24,[185],"PHASE1","This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA\u002FCD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with Multiple Sclerosis.",[188],"Multiple Sclerosis",[190,188,191,192,193],"AZD0120","MS","RMS","PMS",{"date":45,"type":46},{"date":196,"type":46},"2025-12-09",{"date":198,"type":21},"2028-12-12",{"name":200,"class":53},"AstraZeneca",19,{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":17,"minAge":210,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":225},"100610019","phase-3-a-study-of-baricitinib-ly3009104-for-the-delay-of-stage-3-type-1-diabetes-in-at-risk-children-and-adults-100610019","NCT07222137","A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults","A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to \u003C36 Years","BARICADE-DELAY","Inclusion Criteria:\n\n* Have a history of at least one documented occasion of at least two diabetes-related autoantibodies, AND one occasion of at least two diabetes-related autoantibodies obtained at screening or prescreening\n* Have Stage 1b or Stage 2 type 1 diabetes\n* Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening\n\nExclusion Criteria:\n\n* Have any other type of diabetes\n* Have uncontrolled high blood pressure\n* Have had a heart attack, heart disease, stroke, or heart failure\n* Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy\n* Have a current or recent clinically serious infection","1 Year","35 Years",{"count":213,"type":21},150,[67],"The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.",[217],"Diabetes Mellitus, Type 1",{"date":45,"type":46},{"date":220,"type":46},"2026-01-12",{"date":222,"type":21},"2031-07",{"name":224,"class":53},"Eli Lilly and Company",113,{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":257},"100600637","phase-2-study-of-izalontamab-brengitecan-bms-986507-versus-platinum-pemetrexed-for-egfr-mutated-non-small-cell-lung-cancer-after-failure-of-egfr-tki-therapy-izabright-lung01-100600637","NCT07100080","Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)","IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2\u002F3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy","Inclusion Criteria:\n\n* Non-squamous NSCLC, not amenable to treatment in curative intent.\n* Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).\n* Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.\n* Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).\n\nExclusion criteria:\n\n* Inadequate organ function and\u002For bone marrow reserve.\n* Leptomeningeal metastases or spinal cord compression.\n* Poorly controlled systemic medical conditions.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":97,"type":21},[24,67],"A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy",[237],"Non-Small Cell Lung Cancer",[239,240,241,242,243,244,245,246,247,248,249,250],"Epidermal Growth Factor Receptor","Tyrosine Kinase Inhibitors","Osimertinib","Standard of Care","Lung Neoplasms","Antineoplastic Agents","Izalontamab brengitecan","Iza-bren","BL-B01D1","Carboplatin","Cisplatin","Pemetrexed",{"date":45,"type":46},{"date":253,"type":46},"2025-11-05",{"date":255,"type":21},"2030-11-15",{"name":52,"class":53},186,{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":22,"phases":268,"briefSummary":269,"conditions":270,"keywords":272,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":282},"100579143","phase-2-a-study-to-evaluate-the-adverse-events-and-efficacy-of-intravenous-iv-of-telisotuzumab-adizutecan-in-combination-with-iv-oxaliplatin-fluorouracil-folinic-acidleucovorin-bevacizumab-panitumumab-in-adult-participants-with-metastatic-colorectal-cancer-100579143","NCT06820463","A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid\u002FLeucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer","A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Metastatic Colorectal Cancer","AndroMETa-CRC","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Laboratory values meeting the criteria within the protocol.\n* Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.\n\nExclusion Criteria:\n\n* Prior systemic regimen containing c-Met targeting agent(s) (e.g., antibody, antibody drug conjugate, bispecific) and\u002For any topoisomerase inhibitor(s) (e.g., irinotecan).\n* History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death.",{"count":267,"type":21},390,[24],"CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide.\n\nIn the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive 5FU\u002FLV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab\u002Fpantitumumab. The study will run for a duration of approximately 6 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[271],"Metastatic Colorectal Cancer",[271,273,274],"AndroMETa-CRC-533","Telisotuzumab Adizutecan",{"date":45,"type":46},{"date":277,"type":46},"2025-04-24",{"date":279,"type":21},"2028-04",{"name":281,"class":53},"AbbVie",65,{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":290,"enrollmentInfo":291,"targetDuration":4,"studyType":22,"phases":293,"briefSummary":294,"conditions":295,"keywords":299,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":303,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":137},"100569762","alpha-radiation-emitters-dart-with-chemotherapy-for-the-treatment-of-locally-advanced-and-metastatic-pancreatic-cancer-100569762","NCT06698458","Alpha Radiation Emitters (DaRT) With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer","A Study to Assess the Safety of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n* Histologically and\u002For cytologically proven newly diagnosed locally advanced inoperable pancreatic adenocarcinoma (Cohort 1) OR histologically and\u002For cytologically proven newly diagnosed metastatic pancreatic adenocarcinoma (Cohort 2).\n* Patients will start treatment with mFOLFIRINOX (up to 4 cycles) before DaRT insertion\n* Target lesion is technically amenable for Alpha DaRT sources implantation.\n* Measurable lesion per RECIST (version 1.1) criteria\n* Lesion size ≤ 5 cm in the longest diameter\n* Interstitial radiation indication validated by a multidisciplinary team.\n* ECOG Performance Status Scale 0 -2\n* Life expectancy is more than 6 months\n* WBC ≥ 3500\u002Fμl, granulocyte ≥ 1500\u002Fμl\n* Platelet count ≥60,000\u002Fμl\n* Creatinine ≤1.9 mg\u002FdL\n* AST and ALT ≤ 2.5 X upper limit of normal (ULN)\n* INR \\\u003C 1.4 for patients not on Warfarin\n* Age ≥18 years old\n* Subjects are willing and able to sign an informed consent form\n* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after initiation of Alpha DaRT therapy.\n* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT insertion.\n\nExclusion Criteria:\n\n* For Cohort 1 only: Borderline unresectable pancreatic cancer, and\u002For fit for surgical exploration unless patient refuses surgery.\n* For Cohort 1 and Cohort 2: Prior treatment for pancreatic cancer, including chemotherapy except for 1 - 4 cycles of mFOLFIRINOX, radiation therapy, immunotherapy, etc.\n* Known hypersensitivity to any of the components of the treatment.\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.\n* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n* Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n* Has a known additional malignancy that is progressing or requires active treatment.\n\nExceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, low risk prostate cancer, or in situ cervical cancer.\n\n* Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.\n* Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT insertion.\n* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.\n* High probability of protocol non-compliance (in opinion of investigator).\n* Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after DaRT insertion\n* Patients who are at high risk of complications from radiation due to genetic conditions\u002Fmutations, inflammatory bowel disease, or connective tissue disease.","120 Years",{"count":292,"type":21},50,[150],"This is a multi-center clinical study enrolling up to 50 participants. The primary objective of the study is to evaluate the safety of Alpha DaRT in combination with chemotherapy, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE V6. The secondary objectives of the study are to:\n\n* Assess efficacy of the Alpha DaRT sources in combination with chemotherapy, determined by overall and progression-free survival.\n* Assess pain control\n* Assess rate of surgical resection in Cohort 1.",[296,297,298],"Pancreatic Cancer","Pancreatic Adenocarcinoma","Metastatic Pancreatic Cancer",[300,301,297,302],"Alpha radiation","pancreatic cancer","Unresectable Pancreatic Cancer",{"date":45,"type":46},{"date":305,"type":46},"2025-06-17",{"date":307,"type":21},"2026-12",{"name":309,"class":53},"Alpha Tau Medical LTD.",{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":17,"minAge":318,"maxAge":319,"enrollmentInfo":320,"targetDuration":4,"studyType":22,"phases":322,"briefSummary":323,"conditions":324,"keywords":328,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":338},"100568620","sealion-study-on-supplemental-oxygenation-via-nasal-cannula-for-young-children-during-intubation-100568620","NCT06683599","SEALion: Study on Supplemental Oxygenation Via Nasal Cannula for Young Children During Intubation","SEALion: a Study on the Effectiveness of Additional Oxygenation in Little Children During Intubation Using Oxygenation Delivered by Nasal Cannula","SEALION","Inclusion Criteria:\n\n* Pediatric patients requiring oral or nasal tracheal intubation for elective, semi-elective, or urgent surgical and non-surgical procedures.\n* Neonates and infants up to 52 weeks post-conceptual age.\n* Written informed consent provided by legal guardians prior to the intervention.\n\nExclusion Criteria:\n\n* Prediction of difficult intubation based on physical examination or a history of previous difficult intubation.\n* Requirement for an alternative technique to direct laryngoscopy to secure the airway.\n* Specific conditions, such as congenital heart disease requiring FiO₂ \\\u003C 1.0, or cardiopulmonary collapse necessitating advanced life support and intubation for emergency surgical or non-surgical interventions.","1 Minute","52 Weeks",{"count":321,"type":21},240,[150],"Tracheal intubation in neonates can be technically challenging, even for experienced pediatric anesthesiologists, with a high first-attempt success rate crucial to ensure safety. Intubation, while life-saving for children with circulatory shock or respiratory failure, carries risks of severe desaturation that can lead to hypoxic encephalopathy, cardiac arrest, or death. Neonates, especially, are prone to hypoxemia due to high oxygen consumption, low functional residual capacity, small closing capacity, and increased risk of airway collapse, which is exacerbated under anesthesia and neuromuscular paralysis. Rapid desaturation occurs after cessation of ventilation, with neonates facing shorter apnea times before desaturation. Studies show that about two-thirds of neonates undergoing non-emergency nasotracheal intubation experience desaturation (SpO₂ \\\u003C80% for over 60 seconds), although low-flow oxygen supplementation (0.2 L\u002Fkg\u002Fmin) can extend safe apnea time.\n\nThis study aims to investigate apneic oxygenation with VL (using Miller or Macintosh blades size 0 or 1) in operating rooms or intensive care units. We hypothesize that supplemental oxygen and standardized VL use will improve first-pass success rates and reduce adverse events.",[325,326,327],"Difficult Airway","Difficult Airway Intubation","Neonate",[329,330,327],"Difficult intubation","Apneic oxygenation",{"date":45,"type":46},{"date":333,"type":46},"2024-12-10",{"date":335,"type":21},"2027-12-01",{"name":337,"class":172},"Vinícius C Quintão, MD, MSc, PhD",4,{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":22,"phases":348,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":359},"100563701","phase-1-a-study-to-evaluate-safety-pharmacokinetics-and-activity-of-gdc-7035-as-a-single-agent-and-in-combination-in-patients-with-advanced-solid-tumors-100563701","NCT06619587","A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors","A Phase I\u002FII Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors With a KRAS G12D Mutation","Inclusion Criteria:\n\n* Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation\n* Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm\n\nExclusion criteria:\n\n* Malabsorption or other condition that would interfere with enteral absorption\n* Active brain metastases\n* Clinically significant cardiovascular dysfunction or liver disease",{"count":347,"type":21},410,[185],"This is a first-in-human Phase I\u002FII, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the KRAS G12D mutation.",[351],"Solid Tumor",{"date":45,"type":46},{"date":354,"type":46},"2024-11-14",{"date":356,"type":21},"2028-05-31",{"name":358,"class":53},"Genentech, Inc.",42,{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":17,"minAge":368,"maxAge":369,"enrollmentInfo":370,"targetDuration":4,"studyType":22,"phases":372,"briefSummary":373,"conditions":374,"keywords":377,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":386},"100557714","phase-3-a-study-investigating-subcutaneously-administered-pozelimab-in-combination-with-cemdisiran-or-cemdisiran-alone-in-adult-participants-with-geographic-atrophy-100557714","NCT06541704","A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy","A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration","SIENNA","Key Inclusion Criteria:\n\n1. Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol\n2. Total GA area in the study eye measuring between ≥2.5 mm\\^2 and ≤17.5 mm\\^2 as described in the protocol\n3. BCVA of 55 letters or better using ETDRS charts (20\u002F80 Snellen equivalent) in the study eye as described in the protocol\n4. Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol\n5. Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol\n\nKey Exclusion Criteria:\n\n1. GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy\n2. History or current evidence of Macular Neovascularization (MNV) and\u002For exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol\n3. Prior or current Intravitreal (IVT) treatment of any kind for any indication in study eye or fellow eye, except approved or investigational IVT complement inhibitor therapy or anti-VEGF therapy, as long as last dose was ≥6 months prior to randomization\n4. Prior intraocular surgery except cataract extraction or minimally invasive glaucoma surgery in study eye as long as date of these procedures was ≥3 months prior to randomization\n5. Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema, uncontrolled glaucoma, full thickness macular hole) in study eye that could affect central vision and confound study\n6. Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination of the study eye (e.g., advanced cataract or corneal abnormalities) as described in the protocol\n\n   Systemic Exclusion criteria\n7. History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol\n8. History of solid organ or bone marrow transplantation\n9. Use of chronic (\\>14 days) systemic corticosteroids (oral or parenteral, ≥20 mg oral prednisone or equivalent) within the previous 30 days prior to the first screening visit as described in the protocol\n10. Current or prior use of systemic immunosuppressive therapy other than corticosteroids within 12 months prior to randomization or the likelihood of treatment with any such agent during the study inclusive of the screening period as described in the protocol\n11. Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol\n12. Carrier of Neisseria meningitidis based on culture collected during screening\n13. Has a hemoglobin A1C ≥ 8.0% during screening as described in the protocol\n\nNOTE: Other protocol-defined Inclusion\u002F Exclusion Criteria apply","50 Years","85 Years",{"count":371,"type":21},975,[67],"This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision (what one sees straight ahead).\n\nThe purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug(s)\n* How much study drug(s) are in the blood at different times\n* Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)",[375,376],"Age-related Macular Degeneration (AMD)","Geographic Atrophy (GA)",[378],"GA secondary to AMD",{"date":45,"type":46},{"date":381,"type":46},"2024-10-30",{"date":383,"type":21},"2033-04-09",{"name":385,"class":53},"Regeneron Pharmaceuticals",224,{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":17,"minAge":394,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":22,"phases":397,"briefSummary":398,"conditions":399,"keywords":401,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":410,"locationsCount":54},"100544252","phase-3-a-study-of-pitolisant-in-patients-with-prader-willi-syndrome-100544252","NCT06366464","A Study of Pitolisant in Patients With Prader-Willi Syndrome","A Phase 3, Randomized, Double-Blind, Placebo-controlled, Efficacy and Safety Study of Pitolisant Followed by an Open-Label Extension in Patients With Prader-Willi Syndrome","Inclusion Criteria:\n\n* Genetically confirmed diagnosis of PWS\n* Excessive daytime sleepiness\n* Has a consistent parent\u002Fcaregiver (preferably the same person throughout the study) who is willing and able to complete the required study assessments.\n* In the opinion of the Investigator, the patient\u002Fparent(s)\u002Fcaregiver(s)\u002Flegal guardian(s) are capable of understanding and complying with the requirements of the protocol and administration of oral study drug.\n\nExclusion Criteria:\n\n* Has a diagnosis of sleep apnea (OSA, CSA) that is not adequately controlled\n* Has a diagnosis of hypersomnia due to another sleep\u002Fmedical disorder\n* Participation in an interventional research study involving another investigational medication, device, or behavioral treatment within 30 days or 5 half-lives (whichever is longer) of the investigational medication prior to Screening","6 Years",{"count":396,"type":21},134,[67],"This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome.\n\nThe primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome.\n\nSecondary objectives include assessing the impact of pitolisant on:\n\nIrritable and disruptive behaviors Hyperphagia Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity\u002Fnoncompliance, and inappropriate speech",[400],"Prader-Willi Syndrome",[402,403,404,405],"pitolisant","excessive daytime sleepiness","irritable and disruptive behaviors","Prader-Willi syndrome",{"date":45,"type":46},{"date":408,"type":46},"2024-05-28",{"date":279,"type":21},{"name":411,"class":53},"Harmony Biosciences Management, Inc.",{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":420,"minAge":421,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":22,"phases":424,"briefSummary":425,"conditions":426,"keywords":428,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":438},"100522211","phase-3-study-of-volrustomig-in-women-with-high-risk-locally-advanced-cervical-cancer-evolve-cervical-100522211","NCT06079671","Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)","A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)","eVOLVECervical","Inclusion Criteria:\n\nFor inclusion in the study, patients should fulfill the following criteria:\n\n1. Female.\n2. Aged at least 15 years at the time of screening. Note: Participants \\\u003C 18 years of age: physical changes should be aligned with Tanner Stage III.\n3. Body weight \\> 35 kg.\n4. Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease.\n5. Initial staging procedures performed no more than 56 days prior to the first dose of CCRT.\n6. Provision of FFPE tumor sample to assess the PD-L1 expression.\n7. Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent.\n8. WHO\u002FECOG performance status of 0 or 1; duration of life expectancy of ≥ 12 weeks.\n9. Adequate organ and bone marrow function.\n10. Capable of providing signed informed consent.\n\nExclusion Criteria:\n\nPatients should not enter the study if any of the following exclusion criteria are fulfilled:\n\n1. Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.\n2. Evidence of metastatic disease.\n3. Intent to administer a fertility-sparing treatment regimen.\n4. History of organ transplant or allogenic stem cell transplant.\n5. History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.\n6. Uncontrolled intercurrent illness.\n7. History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease.\n8. Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated.\n9. Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula.\n10. History of anaphylaxis to any biologic therapy or vaccine.\n11. Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention is excluded. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication or chemotherapy premedication) or a single dose for palliative purpose (eg, pain control); c) Physiologic doses of oral corticosteroids, ie, not exceeding 10 mg\u002Fday of prednisone (or equivalent) in the preceding 14 days.\n12. Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy.\n13. Any prior (besides prior CCRT) or concurrent treatment for cervical cancer.\n14. Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.\n15. Exposure to immune mediated therapy prior to the study for any indication.\n16. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.\n17. Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.","FEMALE","15 Years",{"count":423,"type":21},800,[67],"This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.",[427],"Locally Advanced Cervical Cancer",[429,430,431],"Locally Advanced Cervical Cancer;","Adolescent and Young Adult;","Volrustomig",{"date":45,"type":46},{"date":434,"type":46},"2023-09-22",{"date":436,"type":21},"2030-09-30",{"name":200,"class":53},205,{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":447,"enrollmentInfo":448,"targetDuration":4,"studyType":22,"phases":450,"briefSummary":451,"conditions":452,"keywords":454,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":464,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":471},"100502809","phase-3-phase-iiib-study-of-ribociclib--et-in-early-breast-cancer-100502809","NCT05827081","Phase IIIb Study of Ribociclib + ET in Early Breast Cancer","A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)","Adjuvant WIDER","Key Inclusion criteria:\n\n* Participant is an adult, male or female ≥ 18 years of age at the time of informed consent form signature (IC).\n* Participant has a histologically and\u002For cytologically confirmed diagnosis of estrogen-receptor positive and\u002For progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample tested by a local laboratory prior to enrollment.\n* Participant has HER2- BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing based on the most recently analyzed tissue sample.\n* Participants may have already received any standard neoadjuvant and\u002For adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrollment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy.\n* For participants with prior ET treatment \\> 12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrollment.\n* The number of participants with prior ET between 12 and 36 months will be capped at 30%. The cap will not apply to Black or African American participants.\n* Participant has no contraindication to receive adjuvant ET in the study.\n* Participant after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:\n\n  * Anatomic Stage Group III, or\n  * Anatomic Stage Group IIB, or\n  * A subset of Anatomic Stage Group IIA.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.\n* Participant has adequate bone marrow and organ function.\n* ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as:\n\n  * QTcF interval at Screening \\\u003C 450 msec (QT interval using Fridericia's correction).\n  * Mean resting heart rate 50-99 beats per minute (determined from the ECG).\n\nKey Exclusion criteria:\n\n* Participant with distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and\u002For evidence of recurrence after curative surgery.\n* Participant is concurrently using other antineoplastic therapy with the exception of adjuvant ET.\n* Participant has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate participant participation in the clinical study or compromise compliance with the protocol, or limit life expectancy to ≤5 years.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality.\n* Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.\n* Women of child-bearing potential (CBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 21 days after stopping the treatment.\n\nOther inclusion\u002Fexclusion criteria may apply","100 Years",{"count":449,"type":21},1400,[67],"The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).",[453],"Early Breast Cancer",[455,456,457,458,459,460,461,462,463],"Hormone receptor positive (HR+)","Human epidermal growth factor receptor-2 negative (HER2-)","Early breast cancer (EBC)","premenopausal","postmenopausal","male breast cancer","ribociclib","LEE011","Endocrine therapy (ET)",{"date":45,"type":46},{"date":466,"type":46},"2024-02-28",{"date":468,"type":21},"2030-09-20",{"name":470,"class":53},"Novartis Pharmaceuticals",228,{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":22,"phases":481,"briefSummary":482,"conditions":483,"keywords":486,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":499},"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":480,"type":21},626,[24,67],"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.",[484,485],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[487,488,37,485,489,490,491],"KRAS G12C","Non-small cell lung cancer","Adagrasib","Krazati","TPS",{"date":45,"type":46},{"date":494,"type":46},"2020-12-02",{"date":496,"type":21},"2029-10-31",{"name":498,"class":53},"Mirati Therapeutics Inc.",770,{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":22,"phases":509,"briefSummary":511,"conditions":512,"keywords":515,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":527},"100258163","phase-4-switching-from-twice-daily-to-once-daily-clozapine-dosing-in-schizophrenia-100258163","NCT02639702","Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia","Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia: A Pilot, Double-Blind, Randomized Controlled Trial","Inclusion Criteria:\n\n* Diagnosed with schizophrenia or schizoaffective disorder based on DSM-IV criteria\n* Outpatient status\n* Ages 18 years or older\n* Has received clozapine twice a day, one of which is in the evening\u002Fbedtime, at the same dose and dosing regimen for at least 3 months\n* Fluent in English and competent to provide written informed consent\n\nExclusion Criteria:\n\n* Having significant medical or neurological illnesses\n* Pregnant or lactating",{"count":508,"type":21},30,[510],"PHASE4","Plasma half-life has routinely been used to establish the dosing schedule of antipsychotics; for example, it is recommended that agents with a short plasma half-life be administered multiple times per day. However, to date, several randomized controlled trials (RCTs) have shown no differences in clinical outcomes between once- and twice-daily dosing of various antipsychotics, suggesting that once-daily dosing of antipsychotics is a viable option regardless of plasma half-life. This would apply to clozapine as well; however, there have been no studies comparing once-daily vs. twice-daily dosing regimens of clozapine in terms of efficacy and tolerability. To address this gap in the literature, the investigators shall conduct a pilot, double-blind, RCT to examine efficacy and tolerability following a switch to once-daily dosing regimen of clozapine in patients with schizophrenia receiving clozapine twice a day.",[513,514],"Schizophrenia","Schizoaffective Disorder",[516,517,518,519,513],"Clozapine","Dosing","Once daily","Regimen",{"date":45,"type":46},{"date":522,"type":46},"2016-10-15",{"date":524,"type":21},"2027-12-31",{"name":526,"class":172},"Centre for Addiction and Mental Health",1,{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":534,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":536,"enrollmentInfo":537,"targetDuration":4,"studyType":22,"phases":539,"briefSummary":540,"conditions":541,"keywords":545,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":558},"100439227","left-vs-right-non-inferiority-trial-100439227","NCT04999553","Left vs. Right Non-Inferiority Trial","Left Intermittent Theta Burst Stimulation vs. Right Low Frequency Repetitive Transcranial Magnetic Stimulation Effectiveness in Depression and Suicidal Ideation: A Randomized Non-Inferiority Trial","LeRNIT","Inclusion Criteria:\n\n1. are female or male;\n2. are outpatients;\n3. are voluntary and competent to consent to treatment;\n4. have a DSM 5 diagnosis of MDD,55 single or recurrent confirmed by Mini-International Neuropsychiatric Interview (MINI) version 7.0;\n5. are 18yo to 65yo;\n6. have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of \\> 3 in the current episode OR have been unable to tolerate at least two separate trials of antidepressants at less than the minimum adequate dose and\u002For duration (ATHF 1 or 2);\n7. have a score ≥ 18 on the Hamilton Depression Rating Scale (HDRS-17 item);\n8. have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;\n9. are able to adhere to the treatment schedule;\n10. pass the TMS and MRI adult safety screening questionnaires.\n\nExclusion Criteria:\n\n1. have a history of substance use within the last 3 months;\n2. have a concomitant major unstable medical illness;\n3. have active suicidal intent;\n4. are pregnant;\n5. have a lifetime (MINI) diagnosis of any psychotic or bipolar disorder;\n6. have a MINI anxiety disorder or personality disorder assessed by a study investigator to be primary and causing greater impairment than MDD;\n7. have failed a course of ECT in the current episode;\n8. have any significant neurological disorder, any history of seizure (except those therapeutically induced by ECT), significant head trauma with loss of consciousness for \\> 5 min;\n9. have any intracranial implant (e.g., aneurysm clips) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;\n10. are participating in psychotherapy, must have been in stable treatment for at least 3 months prior to study entry, with no anticipated change in the frequency of therapeutic sessions, or focus of therapeutic sessions over the duration of the study;\n11. have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;\n12. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview);","65 Years",{"count":538,"type":21},480,[150],"The aim of this study is to test the hypothesis that low-frequency rTMS (LFR) works as well as the established intermittent thetaburst rTMS (iTBS) treatment for treatment resistant depression (TRD).",[542,543,544],"Depression","Major Depressive Disorder","Major Depressive Episode",[546,547,548,549,542,543],"rTMS","TMS","Transcranial Magnetic Stimulation","iTBS","2026-08-23",{"date":45,"type":46},{"date":553,"type":46},"2021-11-08",{"date":555,"type":21},"2027-07-01",{"name":557,"class":172},"University of British Columbia",2,{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":566,"enrollmentInfo":567,"targetDuration":4,"studyType":22,"phases":569,"briefSummary":570,"conditions":571,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":583},"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":568,"type":21},478,[67],"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.",[572,573],"Ganglioneuroblastoma, Nodular","Neuroblastoma","2026-08-22",{"date":45,"type":46},{"date":577,"type":46},"2024-04-19",{"date":579,"type":21},"2029-12-31",{"name":581,"class":582},"National Cancer Institute (NCI)","NIH",179,{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":4,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":591,"targetDuration":4,"studyType":22,"phases":593,"briefSummary":594,"conditions":595,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":606},"100498670","phase-2-comparing-retreatment-of-177lu-dotatate-prrt-versus-the-usual-treatment-in-patients-with-metastatic-unresectable-gastroenteropancreatic-neuroendocrine-tumors-net-retreat-trial-100498670","NCT05773274","Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial","NET RETREAT: A Phase II Study of 177 Lutetium-DOTATATE Retreatment vs. Everolimus or Sunitinib or Cabozantinib in Metastatic\u002FUnresectable Gastroenteropancreatic Neuroendocrine Tumours","Inclusion Criteria:\n\n* Patients must be at least \\>= 18 years of age\n* Metastatic, histologically confirmed grade 1 or 2 well-differentiated gastroenteropancreatic neuroendocrine tumours, including NETs of unknown primary thought to be of gastroenterogancreatic origin, with positive Gallium-68 DOTATATE scan, Copper-64 DOTATATE scan or octreotide scan within the last 12 months is recommended but within the last 36 months is allowed. Lesions on Gallium-68 or Copper-64 DOTATATE scan or octreotide scan will be considered positive if the maximum standardized uptake value (SUVmax) of target lesion is \\> SUV mean of normal liver parenchyma\n\n  * 7th Edition of the TNM Classification of Malignant Tumours\n* Have received 3 or 4 cycles of PRRT using 177Lu-DOTATATE or a cumulative exposure of 22,200 MBq (600mCi) or 29,600 MBq (800 mCi) within +\u002F- 10% variation within a 52-week period. No previous targeted alpha therapy is permitted\n* Have had radiological progression per RECIST 1.1 after prior PRRT treatment and no sooner than 12 months from last scan performed post completion of initial PRRT where either stable disease, partial response, or complete response has been maintained throughout. Patients may have received previous systemic anti-cancer therapy subsequently, as long as they had benefited from initial PRRT for at least 12 months and have had confirmed progression per RECIST 1.1 on the intervening systemic anti-cancer therapy. Somatostatin analogues (SSA) administered for functional control are not considered an intervening systemic anti-cancer therapy. If intervening systemic anti-cancer therapy included a vascular endothelial growth factor (VEGF)-inhibitor, sunitinib can not be selected as standard of care on Arm 2. If intervening systemic anti-cancer therapy included an mammalian target of rapamycin (mTOR)-inhibitor, then everolimus can not be selected as the standard of care on Arm 2. If the intervening therapy is an alkylating agent, exposure of alkylating agent cannot exceed 12 months. The 12-month limit will also be applied to pre PRRT alkylator use as well\n* Patients may have received previous ablative therapy or bland embolization as liver directed therapy however this must not have been received within 12 weeks from randomization date. Previous chemo and radio embolization are not permitted. Any lesion treated with an ablative technique as well as lesions in the lobe(s) of the liver treated with embolization shall not be included in target lesion assessment unless they have since progressed\n* No ongoing toxicity from prior PRRT that is grade 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Hemoglobin \\>= 80 g\u002FL (\\>= 8.0 g\u002FdL) (measured within 28 days prior to enrollment)\n* Absolute neutrophil count \\>= 1.0 x 10\\^9\u002FL (\\>= 1000\u002Fmm\\^3) (measured within 28 days prior to enrollment)\n* Platelets \\>= 80 x 10\\^9\u002FL (\\>= 80 x 10\\^3\u002Fmm\\^3) (measured within 28 days prior to enrollment)\n* Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) (upper limit of normal) (measured within 28 days prior to enrollment)\n\n  * If confirmed Gilbert's, eligible providing =\\\u003C 3.0 x ULN\n* Creatinine clearance \\> 50 mL\u002Fmin (measured within 28 days prior to enrollment)\n\n  * Creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by Cockcroft and Gault equation\n* Prior or current use of somatostatin analogues is allowed for carcinoid syndrome control or in PRRT re-treatment patient population (Arm 1). Patients randomized to Arm 2 and receiving everolimus or sunitinib (pancreatic NET patients only) or cabozantinib (US patients only) will not be allowed to continue somatostatin analogues unless they have functional syndrome\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate\n* Males and females of reproductive potential must have agreed to use a highly effective contraceptive method during protocol treatment and for 7 months after the last dose of protocol treatment for females and 4 months after the last dose of protocol treatment for males. A woman is considered to be of \"childbearing potential\" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy\u002Fvasectomized partner. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he\u002Fshe is responsible for beginning contraceptive measures. Men should avoid fathering a child for 4 months after the last dose of 177Lu-DOTATATE\n\n  * Women of childbearing potential will have a pregnancy test to determine eligibility as part of the Pre-Study Evaluation; this may include an ultrasound to rule-out pregnancy if a false-positive is suspected. For example, when beta-human chorionic gonadotropin is high and partner is vasectomized, it may be associated with tumour production of human chorionic gonadotropin (hCG), as seen with some cancers. Patient will be considered eligible if an ultrasound is negative for pregnancy\n* Patients must be accessible for treatment, response assessment, and follow up. Patients enrolled on this trial must be treated and followed at the participating center. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up\n\n  * Patients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial\n* Patient must have access to everolimus or sunitinib (pancreatic NET patients only) or cabozantinib (US patients only). In the event that site\u002Finvestigator is unable to provide access to the drug, patient will not be eligible for this trial\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* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n\nExclusion Criteria:\n\n* Major surgical procedures within 6 weeks from randomization date\n* Known brain metastases, unless these metastases have been treated, stabilized and off steroids for at least 4 weeks prior to enrollment in the study. Patients with a history of brain metastases must have a head CT and\u002For MRI with contrast to document stable disease prior to enrollment in the study\n* Uncontrolled congestive heart failure no worse than New York Heart Association Class (NYHA) IIB\n* Inability to swallow oral medications or gastrointestinal disease limiting absorption of oral agents\n* Patients with any other significant medical or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study\n* Pregnant women are excluded from this study because 177Lu-DOTATATE is a peptide receptor radionuclide therapy with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 177Lu-DOTATATE, breastfeeding should be discontinued if the mother is treated with everolimus or sunitinib or cabozantinib (US patients only) and for 2.5 months following the last treatment with 177Lu-DOTATATE",{"count":592,"type":21},100,[24],"This phase II trial compares the effect of retreatment with 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) to the usual approach of treatment with everolimus, sunitinib, or cabozantinib in patients who have previously received 177Lu-DOTATATE for gastroenteropancreatic neuroendocrine tumor (GEPNET) that has spread from where it first started (primary site) to other places in the body (metastatic) and that cannot be removed by surgery (unresectable). PRRT is a type of radiation therapy for which a radioactive chemical is linked to a peptide (small protein) that targets tumor cells. When this radioactive peptide is injected into the body, it binds to a specific receptor found on some tumor cells. The radioactive peptide builds up in these cells and helps kill the tumor cells without harming normal cells. In this trial 177Lu-DOTATATE is used for PRRT. 177Lu-DOTATATE PRRT may increase the length of time until worsening of the GEPNET compared to the usual approach. Everolimus is in a class of medications called kinase inhibitors. It is also a type of angiogenesis inhibitor. Everolimus works by stopping tumor cells from reproducing and by decreasing blood supply to the tumor cells. Sunitinib and cabozantinib, block certain proteins, which may help keep tumor cells from growing. They may also prevent the growth of new blood vessels that tumors need to grow. Sunitinib malate is a type of tyrosine kinase inhibitor and a type of antiangiogenesis agent. Retreating with 177Lu-DOTATATE may work better than everolimus, sunitinib or cabozantinib in shrinking or stabilizing tumors in patients with metastatic and unresectable GEPNET who were previously treated with 177Lu-DOTATATE.",[596,597,598,599],"Metastatic Digestive System Neuroendocrine Tumor G1","Metastatic Digestive System Neuroendocrine Tumor G2","Unresectable Digestive System Neuroendocrine Tumor G1","Unresectable Digestive System Neuroendocrine Tumor G2",{"date":45,"type":46},{"date":602,"type":46},"2024-01-12",{"date":604,"type":21},"2029-04-30",{"name":581,"class":582},40,{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":4,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":17,"minAge":614,"maxAge":146,"enrollmentInfo":615,"targetDuration":4,"studyType":22,"phases":617,"briefSummary":618,"conditions":619,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":627},"100491152","a-study-to-compare-standard-therapy-to-treat-hodgkin-lymphoma-to-the-use-of-two-drugs-brentuximab-vedotin-and-nivolumab-100491152","NCT05675410","A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab","A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma","Inclusion Criteria:\n\n* Patients must be 5 to 60 years of age at the time of enrollment\n* Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified \\[NOS\\]) with stage I or II disease\n* Patients must have bidimensionally measurable disease (at least one lesion with longest diameter \\>= 1.5 cm)\n* Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained\n* Pediatric patients (age 5-17 years) with known or suspected mediastinal disease must have an upright posteroanterior (PA) chest X-ray (CXR) for assessment of bulky mediastinal disease.\n\n  * Note: Pediatric patients who have received both a CT chest and upright PA CXR may meet the definition of bulk through either modality.\n* Patients \\>= 18 years must have a performance status corresponding to Zubrod scores of 0, 1 or 2\n* Patients =\\\u003C 17 years of age must have a Lansky performance score of \\>= 50\n* Pediatric patients (age 5-17 years): A serum creatinine based on age\u002Fsex as follows (within 28 days prior to enrollment):\n\n  * 2 to \\\u003C 6 years (age): 0.8 mg\u002FdL (male), 0.8 mg\u002FdL (female)\n  * 6 to \\\u003C 10 years (age): 1 mg\u002FdL (male), 1 mg\u002FdL (female)\n  * 10 to \\\u003C 13 years (age): 1.2 mg\u002FdL (male), 1.2 mg\u002FdL (female)\n  * 13 to \\\u003C 16 years (age): 1.5 mg\u002FdL (male), 1.4 mg\u002FdL (female)\n  * \\>= 16 years (age): 1.7 mg\u002FdL (male), 1.4 mg\u002FdL (female) OR a 24 hour urine creatinine clearance \\>= 50 mL\u002Fmin\u002F1.73 m\\^2 (within 28 days prior to enrollment) OR a glomerular filtration rate (GFR) \\>= 50 mL\u002Fmin\u002F1.73 m\\^2 (within 28 days prior to enrollment). 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  * Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility\n* For adult patients (age 18 years or older) (within 28 days prior to enrollment): Creatinine clearance \\>= 30 mL\u002Fmin, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight\n* Total bilirubin =\\\u003C 2 x upper limit of normal (ULN) (within 28 days prior to enrollment)\n\n  * Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome\n* Aspartate aminotransferase (AST) =\\\u003C 3 x ULN (within 28 days prior to enrollment)\n\n  * Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome\n* Alanine aminotransferase (ALT) =\\\u003C 3 x ULN (within 28 days prior to enrollment)\n\n  * Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome\n* Shortening fraction of \\>= 27% by echocardiogram (ECHO), multigated acquisition scan (MUGA), or functional cardiac imaging scan (within 28 days prior to enrollment) or ejection fraction of \\>= 50% by radionuclide angiogram, ECHO, MUGA, or cardiac imaging scan (within 28 days prior to enrollment)\n* Diffusion capacity of the lung for carbon monoxide (DLCO) \\>= 50% of predicted value as corrected for hemoglobin by pulmonary function test (PFT) (within 28 days prior to enrollment). If unable to obtain PFTs, the criterion is: a pulse oximetry reading of \\> 92% on room air\n* Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n\nExclusion Criteria:\n\n* Patients with nodular lymphocyte predominant Hodgkin lymphoma\n* Patients with a history of active interstitial pneumonitis or interstitial lung disease\n* Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients\n* Patients with any known uncontrolled intercurrent illness that would jeopardize the patient's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, and gastrointestinal disorders affecting swallowing and\u002For absorption of pills\n* Patients with a condition requiring systemic treatment with either corticosteroids (defined as equivalent to \\> 10 mg daily predniSONE for patients \\>= 18 years or \\> 0.5 mg\u002Fkg \\[up to 10 mg\u002Fday\\] for patients \\\u003C 18 years) or other immunosuppressive medications within 14 days prior to enrollment\n\n  * Note: Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment. Inhaled or topical steroids, and adrenal replacement doses (=\\\u003C 10 mg daily for patients \\>= 18 years or =\\\u003C 0.5 mg\u002Fkg \\[up to 10 mg\u002Fday\\] predniSONE equivalents) are permitted in the absence of active autoimmune disease\n  * Note: Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued by cycle 1, day 1\n  * Short term use of corticosteroids for premedication or treatment of an allergy or hypersensitivity is considered an acceptable use of corticosteroids.\n* Patients with peripheral neuropathy \\> grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL\n* Prior solid organ transplant\n* Prior allogeneic stem cell transplantation\n* Live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, bacillus Calmette Guerin \\[BCG\\], oral polio vaccine, and oral typhoid). Administration of messenger ribonucleic acid (mRNA) vaccines are permitted\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test within 28 days prior to enrollment is required for female patients of childbearing potential\n* Lactating females who plan to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last treatment\n* Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method for the duration of their study drug therapy. Following therapy, patients will be advised to use contraception as per institutional practice or as listed below for investigational agents, whichever is longer\n\n  * Men and women of childbearing potential (WOCBP) must use effective contraception during the study and for 2 months for WOCBP and 4 months for men, after last dose of brentuximab vedotin\n  * WOCBP must continue contraception for a period of at least 5 months after the last dose of nivolumab\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","5 Years",{"count":616,"type":21},1875,[67],"This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride 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. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and\u002For fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.",[620],"Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8",{"date":45,"type":46},{"date":623,"type":46},"2023-05-11",{"date":625,"type":21},"2031-04-28",{"name":581,"class":582},408,{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":4,"eligibilityCriteria":634,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":635,"enrollmentInfo":636,"targetDuration":4,"studyType":22,"phases":638,"briefSummary":639,"conditions":640,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":642,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":646,"locationsCount":647},"100481851","phase-2-comparing-cytarabine--daunorubicin-therapy-versus-cytarabine--daunorubicin--venetoclax-versus-venetoclax--azacitidine-in-younger-patients-with-intermediate-risk-aml-a-myelomatch-treatment-trial-100481851","NCT05554393","Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)","A Measurable Residual Disease (MRD) Focused, Phase II Study of Venetoclax Plus Chemotherapy for Newly Diagnosed Younger Patients With Intermediate Risk Acute Myeloid Leukemia: A Tier 1 MYELOMATCH SubStudy","Inclusion Criteria:\n\n* Participants must have been registered to master screening and re-assessment protocol (MYELOMATCH) prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox Protocol Assignment Team, prior to registration to this study. Participants must have agreed to have specimens submitted for translational medicine and must be offered the opportunity to submit biosamples for banking for future research as per MYELOMATCH\n\n  * Note: Pre-enrollment\u002Fdiagnosis labs must have already been performed under MYELOMATCH\n* Previously untreated, de novo acute myeloid leukemia (AML) defined by \\>= 20% myeloblasts in the peripheral blood or bone marrow (as defined by the current World Health Organization \\[WHO\\] classification of myeloid neoplasms and acute leukemia) excluding all the following categories of AML:\n\n  * Favorable cytogenetics: (t(8;21)q22;q22.1); RUNX1-RUNX1T1, inversion 16(p13.1;q22), t(16;16)(p13.1;q22); CBFB-MYH11\n  * CEBPA biallelic mutations\n  * NPM1 mutation\n  * AML with PML-RARalpha\n  * AML with any adverse cytogenetics, TP53 mutation, RUNX1 mutation, ASXL1, 11q23\u002FKMT2 rearrangements\n  * AML with FLT3-ITD mutation\n  * Therapy related AML, or AML following a diagnosis of myelodysplasia or myeloproliferative neoplasm Participants with central nervous system (CNS) disease are eligible for this trial and will be treated according to institutional guidelines with intrathecal chemotherapy for this aspect of their disease\n* Age 18-59 years at time of induction therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 3\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN) (must be done within 10 days of enrollment)\n* Aspartate aminotransferase (AST) (serum glutamate pyruvate transaminase \\[SGPT\\]) and\u002For alanine aminotransferase (ALT) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) =\\\u003C 3 × institutional ULN (must be done within 10 days of enrollment)\n* Cardiac ejection fraction \\>= 50% (echocardiography or MUGA) (if clinically indicated must be done within 14 days of enrollment)\n* Calculated creatinine clearance \\>= 30 mL\u002Fmin; Clearance to be calculated using Cockcroft formula (must be done within 10 days of enrollment)\n* White blood cells (WBC) must be =\\\u003C 25 x 10\\^9\u002FL. Hydroxyurea and leukapheresis are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped prior to the initiation of protocol therapy. Hydroxyurea +\u002F- no more than a total of 2500 mg cytarabine over a total of multiple days for urgent cytoreduction is also permitted\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Males and females of reproductive potential must have agreed to use a highly effective contraceptive method while on treatment and for 6 months after stopping study drug. A woman is considered to be of \"childbearing potential\" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy\u002Fvasectomized partner. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he\u002Fshe is responsible for beginning contraceptive measures.\n\nWomen of childbearing potential will have a pregnancy test to determine eligibility as part of the pre-study evaluation; this may include an ultrasound to rule-out pregnancy if a false-positive is suspected. Patient will be considered eligible if an ultrasound is negative for pregnancy\n\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate\n* Patients must be accessible for treatment, response assessment and follow up. Patients enrolled on this trial must be treated and followed at the participating centre. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.\n\nPatients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial\n\n* In accordance with Canadian Cancer Trials Group (CCTG) policy, protocol treatment is to begin within 7 working days of patient enrollment\n* Patients with known human immunodeficiency virus (HIV) infection who are on effective anti-retroviral therapy and have undetectable viral load within 6 months of enrollment are eligible for this trial\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days of enrollment. Patients need to be on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection who have been treated and cured are eligible. Patients who with active HCV infection who are currently being treated must have an undetectable HCV viral load within 28 days of enrollment to be eligible\n\nExclusion Criteria:\n\n* Prior therapy for AML except for hydroxyurea and leukapheresis to control blood counts. The use of all-trans retinoic acid (ATRA) is permitted until a diagnosis of acute promyelocytic leukemia, if suspected, is ruled out\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cytarabine, daunorubicin, azacitidine, venetoclax\n* Pregnant women are excluded from this study because venetoclax, cytarabine and azacitidine have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, cytarabine and azacitidine breastfeeding should be discontinued if the mother is treated with venetoclax, cytarabine and azacitidine. These potential risks may also apply to other agents used in this study\n* Patients with isolated myeloid sarcoma are not eligible\n* Any other serious intercurrent illness, life threatening condition, organ system dysfunction, or medical condition judged by the local investigator to compromise the subject's safety (for example):\n\n  * Active, uncontrolled bacterial, fungal, or viral infection","59 Years",{"count":637,"type":21},153,[24],"This phase II MyeloMATCH treatment trial compares cytarabine with daunorubicin versus cytarabine with daunorubicin and venetoclax versus venetoclax with azacitidine for the treatment of younger patients with intermediate risk acute myeloid leukemia (AML). Cytarabine is a drug that inhibits some of the enzymes needed for deoxyribonucleic acid (DNA) replication and repair and can slow or stop the growth of cancer cells. Daunorubicin is a drug that blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Azacitidine is a drug that interacts with DNA to activate tumor-suppressing genes, resulting in an anti-tumor effect. Adding venetoclax to cytarabine and daunorubicin, and adding venetoclax to azacitidine, may work better than the usual treatment of cytarabine with daunorubicin alone. To decide if they are better, the study doctors are looking to see if venetoclax increases the rate of elimination of AML in participants by 20% or more compared to the usual approach.",[641],"Acute Myeloid Leukemia",{"date":45,"type":46},{"date":644,"type":46},"2024-09-13",{"date":524,"type":21},{"name":581,"class":582},181,{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":4,"eligibilityCriteria":654,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":655,"enrollmentInfo":656,"targetDuration":4,"studyType":22,"phases":657,"briefSummary":658,"conditions":659,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":661,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":527},"100478217","phase-2-stem-cell-study-in-osteoarthritis-of-the-knee-and-hip-joints-100478217","NCT05507099","Stem Cell Study in Osteoarthritis of the Knee and Hip Joints","A Phase 2, Randomized Study to Compare Bone Marrow Aspirate Versus Lipoaspirate Concentrate Autologous Cell Therapy for the Treatment of the Knee and Hip Osteoarthritis in Adults","Inclusion Criteria:\n\n1. Male or female, aged 18 to 95 years old\n2. Residents of Canada\n3. Written informed consent to participate in the study\n4. Willingness and ability to comply with the study procedures and phone visit schedules and ability to follow verbal and written instruction\n5. The NRS for at least 5 daily measures will be used to calculate the average score. An average NRS pain score 4-9 (moderate to severe pain).\n6. Diagnosis of symptomatic knee or hip osteoarthritis for at least 12 weeks prior to screening based on an X-ray performed within 1 year prior to screening period.\n7. Radiographic evidence of OA of the index knee or hip (Kellgren-Lawrence Grade I to IV) within 1 year prior to screening or during the screening period.\n8. Failed conservative treatment for more than 12 weeks before the screening, meaning that pain persists for more than 12 weeks after the patient tried two or more of the following medication or interventions in that period.\n\n   * oral analgesics, including over-the-counter medications and supplements,\n   * physiotherapy\n   * acupuncture\n   * bracing\n   * cortisone injections,\n   * hyaluronic acid injections,\n   * dextrose injections (prolotherapy)\n   * platelet-rich plasma injections\n9. Women of childbearing potential must use an effective method of contraception from 14 days prior to baseline visit to 360 days after intervention. Effective birth control considered for this trial are total abstinence; consistent use of birth control pills; injectable birth control methods; intrauterine device placement; and tubal ligation or male partner with vasectomy; diaphragm with contraceptive jelly or condom with contraceptive foam.This does not apply to male and postmenopausal women.\n10. Body mass index (BMI) ≤ 50 kg\u002Fm2\n\nExclusion Criteria:\n\n1. Women who are pregnant or planning to become pregnant during the trial period.\n2. Women of childbearing potential (not surgically sterile or post-menopausal for at least one year) not using a highly effective method of contraception such as total abstinence; consistent use of birth control pills; injectable birth control methods; intrauterine device placement; and tubal ligation or male partner with vasectomy; diaphragm with contraceptive jelly or condom with contraceptive foam.\n3. History of malignancy except for the diagnosis of basal cell carcinoma, within 5 years prior to pre-screening.\n4. Presence of retained rods or screws or insertion or joint replacement in the joint to be injected\n5. History of autoimmune diseases including lupus and rheumatoid arthritis\n6. Prior arthroscopic or open surgery of the index joint within 6 months prior to screening\n7. Planned arthroscopic or open surgery of the index joint during study period\n8. Intra-articular injections in the index joint within 3 months prior to screening for corticosteroids or dextrose injections, and within 6 months prior to screening for hyaluronic acid or platelet-rich plasma (PRP) injections\n9. Use of systemic immunosuppressives, immunomodulators or chemotherapeutic agents within 3 months prior to baseline visit\n10. Know hypersensitivity to lidocaine, epinephrine or heparin\n11. History of coagulopathy\n12. Fever (forehead temperature above 38.0 centigrade) at baseline visit\n13. Subjects with cutaneous infection at the lipoaspirate or bone marrow aspirate site and\u002For in the area of the injection at baseline visit\n14. Subjects with hemoglobin less than 10 g\u002FL\n15. Subjects with platelet count less than 155x109\u002FL\n16. Subjects participating in a study of an experimental drug or medical device within 30 days of study entry\n17. Any medical condition the qualified investigator believes makes the patient unsuitable for the study\n18. Subjects using warfarin before the screening, with an INR above 3","95 Years",{"count":65,"type":21},[24],"The purpose of this trial is to compare the effect of a single intra-articular injection of Lipoaspirate Concentrate vs Bone Marrow Aspirate on pain reduction and functional improvement in the treatment of the knee and hip OA.",[660],"Osteoarthritis",{"date":45,"type":46},{"date":663,"type":46},"2022-08-23",{"date":665,"type":21},"2028-08-08",{"name":667,"class":172},"Grigory Karmy",{"id":669,"slug":670,"hasResults":12,"nctId":671,"briefTitle":672,"officialTitle":673,"acronym":4,"eligibilityCriteria":674,"healthyVolunteers":12,"sex":17,"minAge":675,"maxAge":676,"enrollmentInfo":677,"targetDuration":4,"studyType":22,"phases":679,"briefSummary":680,"conditions":681,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":683,"startDateStruct":684,"completionDateStruct":686,"leadSponsor":688,"locationsCount":689},"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":678,"type":21},132,[185,24],"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.",[682],"Malignant Glioma",{"date":45,"type":46},{"date":685,"type":46},"2022-05-31",{"date":687,"type":21},"2027-06-30",{"name":581,"class":582},127,""]