[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Argentina\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":717},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,610,0,25,[9,46,83,117,146,171,204,232,272,306,331,358,382,409,435,456,479,501,540,565,587,610,639,660,680],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100652278","molecular-ovarian-cancer-assessment-in-latinoamerican-patients-100652278",false,"NCT07771400","Molecular Ovarian Cancer Assessment in LatiNoAmerican PAtients","MOANA","Inclusion Criteria:\n\n1. Participants ≥18 years-old.\n2. Patients diagnosed with ovarian, fallopian tube or peritoneal cancer:\n\n   1. advanced stages stage III or IV by FIGO disease stage\n   2. new diagnosis and persistent or recurrent disease\n3. Diagnosed from 2018 to 2024.\n4. Histologically confirmed diagnosis of serous (low or high grade), endometrioid, mucinous or clear cell ovarian carcinoma.\n5. Accept to participate in the project and sign the informed consent (if applicable).\n6. An archived representative formalin-fixed paraffin-embedded (FFPE) tumor specimen in tumor tissue blocks (preferred) or freshly sectioned unstained slides (at least 20) from biopsy\u002Fsurgery is mandatory.\n\nExclusion Criteria:\n\n1. Histological ambiguous diagnosis upon review.\n2. Diagnosis based on cytology and without any biopsy or surgical specimen.\n3. Patients diagnosed and staged but not receiving any treatment.\n4. Patients without medical records available (lost, empty or irretrievable clinical information).","FEMALE","18 Years",{"count":20,"type":21},320,"ESTIMATED","OBSERVATIONAL","This is a multicentric observational study conducted at selected sites across Latin America. Eligible participants will be identified through the medical records of participating institutions. The study aims to describe overlap of expression of folate receptor alpha (FRα), HER2 and PD-L1 using immunohistochemistry (IHC) and HRD and BRCA (somatic and germline) by NGS. Additionally, to describe clinical demographic and socioeconomic variables, as well as treatment patterns, pathological characteristics, outcomes, and genetic and molecular testing part of clinical practice.\n\nAll data (including patient characteristics, treatment patterns, outcomes and available tests) will be collected once, retrospectively from medical records, ensuring adherence to ethical standards and participant confidentiality. Biomarkers analysis (including FRα, HER2 and PD-L1) will be performed prospectively, a Formalin-Fixed Paraffin-Embedded (FFPE) tumor block will be collected to evaluate and describe the expression of folate receptor alpha (FRα) and HER2, using immunohistochemistry (IHC) with the Roche Ventana kit (FOLR1 and HER2 4B5) and Dako's 22C3 for PD-L1. The study will analyze samples collected between 1st January 2018 to 31 December 2024 (analysis of historically collected samples).\n\nThe study comprises a retrospective data collection from medical charts. Participants will continue to receive treatment and clinical evaluations according to what is determined by their medical team, according to the usual standards of treatment and clinical practice of each center. No intervention or prospective follow-up is proposed in this study.",[25,26,27,28,29,30],"Ovarian Cancer by FIGO Stage","Ovarian Cancer Stage III","Ovarian Cancer Stage IV","Fallopian Tube Cancer Stage III","Fallopian Tube Cancer Stage IV","Fallopian Tube Cancers",[32],"Peritonial Cancer","NOT_YET_RECRUITING","2026-08-24",{"date":36,"type":37},"2026-08-25","ACTUAL",{"date":39,"type":21},"2026-09",{"date":41,"type":21},"2027-08",{"name":43,"class":44},"Latin American Cooperative Oncology Group","OTHER",17,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"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.","ALL","25 Years",{"count":57,"type":21},400,"INTERVENTIONAL",[60,61],"PHASE2","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.",[64],"Huntington Disease",[66,67,68,69,64,70,71,72],"SKY-0515","Skyhawk","HTT","Neurodegenerative","mRNA","Splicing","Mutant Huntingtin protein","RECRUITING",{"date":36,"type":37},{"date":76,"type":37},"2026-01-06",{"date":78,"type":21},"2029-08",{"name":80,"class":81},"Skyhawk Therapeutics, Inc.","INDUSTRY",22,{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":58,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"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":91,"type":21},500,[60,61],"A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy",[95],"Non-Small Cell Lung Cancer",[97,98,99,100,101,102,103,104,105,106,107,108],"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":36,"type":37},{"date":111,"type":37},"2025-11-05",{"date":113,"type":21},"2030-11-15",{"name":115,"class":81},"Bristol-Myers Squibb",186,{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":58,"phases":127,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":20},"100597842","a-study-to-compare-the-combination-of-navlimetostat-bms-986504-with-pembrolizumab-and-chemotherapy-versus-placebo-plus-pembrolizumab-and-chemotherapy-in-first-line-metastatic-non-small-cell-lung-cancer-participants-with-homozygous-mtap-deletion-100597842","NCT07063745","A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","A Randomized Phase 2\u002F3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","MountainTAP-29","Inclusion Criteria\n\n* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.\n* Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Participants must have at least 1 measurable lesion as per RECIST v1.1.\n\nExclusion Criteria\n\n* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.\n* Participants must not have symptomatic brain metastases or spinal cord compression.\n* Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).\n\nNote: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.\n\n* Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":126,"type":21},590,[60,61],"The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion",[130],"Metastatic Non-small Cell Lung Cancer With MTAP Deletion",[132,133,134,135,136,137,138,139],"PRMT5","Lung cancer","NSCLC","MTAP","CDKN2A","MRTX1719","First-line","Navlimetostat",{"date":36,"type":37},{"date":142,"type":37},"2026-01-02",{"date":144,"type":21},"2031-08-12",{"name":115,"class":81},{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":58,"phases":156,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},"100587506","phase-3-a-study-to-assess-the-long-term-safety-of-karxt-for-the-treatment-of-manic-episodes-in-bipolar-i-disorder-balsam-3-100587506","NCT06929273","A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)","A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)","Inclusion Criteria:\n\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  a. Participants must have completed treatment period of parent study.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania.\n  2. Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.\n  3. Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.\n  4. Participants does not require hospitalization for acute mania.\n\nExclusion Criteria:\n\n* All participants:\n\n  1\\. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS.\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  1\\. Discontinuation from any KarXT parent studies.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).\n  2. Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.\n  3. Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test.\n  4. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.\n  5. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","65 Years",{"count":155,"type":21},450,[61],"This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)\n\nThe primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.",[159],"Bipolar Disorder Type I With Mania",[161,162,163],"Bipolar-I disorder","Mania","Bipolar-I disorder with Mania",{"date":36,"type":37},{"date":166,"type":37},"2025-07-18",{"date":168,"type":21},"2028-06-13",{"name":115,"class":81},174,{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":58,"phases":182,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":203},"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":181,"type":21},1400,[61],"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).",[185],"Early Breast Cancer",[187,188,189,190,191,192,193,194,195],"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":36,"type":37},{"date":198,"type":37},"2024-02-28",{"date":200,"type":21},"2030-09-20",{"name":202,"class":81},"Novartis Pharmaceuticals",228,{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":58,"phases":213,"briefSummary":214,"conditions":215,"keywords":218,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":231},"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":212,"type":21},626,[60,61],"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.",[216,217],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[219,220,134,217,221,222,223],"KRAS G12C","Non-small cell lung cancer","Adagrasib","Krazati","TPS",{"date":36,"type":37},{"date":226,"type":37},"2020-12-02",{"date":228,"type":21},"2029-10-31",{"name":230,"class":81},"Mirati Therapeutics Inc.",770,{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":179,"enrollmentInfo":239,"targetDuration":4,"studyType":58,"phases":241,"briefSummary":243,"conditions":244,"keywords":250,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":271},"100311904","phase-4-dabrafenib-andor-trametinib-rollover-study-100311904","NCT03340506","Dabrafenib and\u002For Trametinib Rollover Study","Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and\u002For Trametinib Study","Inclusion Criteria:\n\n* Patient is currently receiving treatment with dabrafenib\u002Ftrametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.\n* In the opinion of the Investigator would benefit from continued treatment.\n\nExclusion Criteria:\n\n* Patient has been previously permanently discontinued from study treatment in the parent protocol.\n* Patient's indication is commercially available and reimbursed in the local country.\n* Patient currently has unresolved toxicities for which dabrafenib and\u002For trametinib dosing has been interrupted in the parent study.",{"count":240,"type":21},100,[242],"PHASE4","This study is to provide access for patients who are receiving treatment with dabrafenib and\u002For trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.",[245,246,247,248,249],"Melanoma","Non Small Cell Lung Cancer","Solid Tumor","Rare Cancers","High Grade Glioma",[251,252,253,254,255,245,256,257,258,259,260,246,261,262,263,264,249],"Tafinlar","Mekinist","Dabrafenib","Trametinib","Adult","Melanoma Stage IV","Metastatic Melanoma","Advanced Melanoma","Lung Cancer","NSLC","BRAF V600 Mutation","BRAF Gene Mutation","Solid tumor","Rare cancers",{"date":36,"type":37},{"date":267,"type":37},"2018-01-26",{"date":269,"type":21},"2032-12-28",{"name":202,"class":81},33,{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":58,"phases":282,"briefSummary":283,"conditions":284,"keywords":291,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":301,"leadSponsor":303,"locationsCount":305},"100653395","phase-2-a-study-of-clazakizumab-ly5724886-in-adults-with-elevated-hscrp-and-at-increased-risk-for-cardiovascular-event-100653395","NCT07783802","A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event","A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Clazakizumab in Reducing hsCRP in Adults With Elevated hsCRP and Established ASCVD or at Increased Risk for ASCVD Events","CLARITY-CRP","Inclusion Criteria:\n\n* hsCRP ≥2 mg\u002FL and ≤15 mg\u002FL at screening\n* At least one of the following chronic conditions:\n\n  * Established atherosclerotic cardiovascular disease (ASCVD)\n  * Obesity (body mass index (BMI) ≥30 kg\u002Fm2)\n  * Type 2 diabetes\n  * Hypertension\n  * Chronic kidney disease Grade 3 or 4\n\nExclusion Criteria:\n\n* Acute cardiovascular event within 60 days prior to screening\n* Acute decompensated heart failure hospitalization within 60 days prior to screening\n* Planned coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or major surgery at the time of randomization\n* New York Heart Association Class III or IV heart failure\n* Uncontrolled hypertension at screening (systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg)\n* Type 1 diabetes\n* Type 2 diabetes with Hemoglobin A1c ≥9.0% (86 mmol\u002Fmol) at screening\n* Nephrotic syndrome, estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73 m², or history of kidney transplant\n* Dialysis or acute kidney injury within 60 days prior to screening\n* Congenital\u002Fhereditary kidney disease, polycystic kidney disease, lupus nephritis, or antineutrophil cytoplasmic antibody-associated vasculitis\n* Active tuberculosis, untreated latent tuberculosis, or known hepatitis B or hepatitis C infection\n* Serious, opportunistic, chronic, or recurrent infection requiring treatment within 12 weeks prior to screening\n* Significant active autoimmune disease\n* Suspected or confirmed immunocompromised state (e.g., HIV infection)\n* History of peptic ulcer disease or gastrointestinal ulceration within 12 months prior to screening\n* History of diverticular disease, gastrointestinal perforation, or major gastrointestinal surgery\n* Mechanical heart valve prosthesis requiring chronic vitamin K antagonist anticoagulation\n* Use of colchicine within 14 days prior to screening or anticipated need during the study\n* Use of immunosuppressive or immunomodulatory agents, including other biologic anti-IL-6 therapies, within specified windows prior to screening\n* Use of systemic corticosteroids within 14 days prior to screening\n* Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs)",{"count":281,"type":21},120,[60],"The purpose of this study is to measure the change in high-sensitivity C-reactive protein (hsCRP), a marker of inflammation in the body, with clazakizumab compared with placebo in adults who have elevated hsCRP and at increased risk for cardiovascular event.\n\nParticipation in the study will last about 9 months.",[285,286,287,288,289,290],"Atherosclerosis","Cardiovascular Disease","Obesity","Hypertension","Diabetes Mellitus, Type 2","Renal Insufficiency, Chronic",[292,293,294,295,296,297],"Interleukin-6 (IL-6)","IL-6 inhibition","C-reactive protein","Residual inflammatory risk","Cardiovascular risk","Monoclonal antibody","2026-08-21",{"date":36,"type":37},{"date":39,"type":21},{"date":302,"type":21},"2027-10",{"name":304,"class":81},"Eli Lilly and Company",47,{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":58,"phases":316,"briefSummary":317,"conditions":318,"keywords":320,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":330},"100653263","phase-3-a-study-to-evaluate-effect-of-azd6234-in-adult-participants-with-obesity-or-overweight-with-weight-related-comorbidity-without-type-2-diabetes-mellitus-100653263","NCT07784725","A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus","A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity Without Type 2 Diabetes Mellitus (SELENE 1)","SELENE 1","Inclusion Criteria:\n\n* Males \\& females (inclusive of all gender identities) age ≥18 years\n* BMI ≥30 kg\u002Fm2 OR BMI ≥27 kg\u002Fm2 with at least one of the following weight related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence\n* Stable body weight (≤5% body weight change) for at least 3 months prior to Randomisation\n* History of at least one self-reported unsuccessful attempt to lose body weight in their lifetime\n\nExclusion Criteria:\n\n* Obesity primarily caused by other endocrine disorders\n* History of Type 1 or Type 2 Diabetes Mellitus, HbA1c ≥6.5% (48 mmol\u002Fmol), and\u002For treatment with glucose-lowering agent(s) within 3 months prior to Screening\n* Significant hepatobiliary disease and\u002For any of the following results at Screening:\n\n  * ALT ≥ 3.0 × ULN\n  * AST ≥ 3.0 × ULN\n  * TBL \\> 1.5 × ULN (except for cases of known Gilbert's Syndrome)\n* Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation.",{"count":315,"type":21},2500,[61],"The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment",[319],"Obesity or Overweight",[287,321,322],"Overweight","AZD6234",{"date":36,"type":37},{"date":325,"type":37},"2026-08-19",{"date":327,"type":21},"2029-05-21",{"name":329,"class":81},"AstraZeneca",212,{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":54,"minAge":339,"maxAge":340,"enrollmentInfo":341,"targetDuration":4,"studyType":58,"phases":343,"briefSummary":344,"conditions":345,"keywords":347,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":357},"100651359","phase-2-a-study-of-brenipatide-ly3537031-in-adult-participants-with-moderate-to-severe-chronic-obstructive-pulmonary-disease-copd-100651359","NCT07759245","A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)","A Phase 2, Multicenter, Randomized, Double-Blind, 52-week Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)","RENEW-COPD","Inclusion Criteria:\n\n* Have a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD), at least 12 months prior to screening who meet the following criteria:\n\n  * Current or former smokers with a smoking history of greater than or equal to (≥) 10 pack-years\n  * Moderate-to-severe COPD (post-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)\u002Fforced vital capacity (FVC) less than (\\\u003C) 70 percent (%)\n  * Modified Medical Research Council Dyspnea Scale (mMRC-DS) grade ≥2\n  * Exacerbation history of ≥2 moderate or ≥1 severe exacerbations within the year prior to inclusion.\n  * Background double therapy \\[long-acting β₂-agonists (LABA) + long-acting muscarinic antagonists (LAMA)\\] or triple therapy \\[inhaled corticosteroids (ICS) + LABA + LAMA)\\] for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to screening.\n\nExclusion Criteria:\n\n* Have a known pre-existing, clinically important lung condition other than COPD.\n* Have a current or recent acute, active infection before screening and up to randomization.","40 Years","75 Years",{"count":342,"type":21},606,[60],"The main purpose of this study is to assess if different dose levels of Brenipatide are safe and work the way they are intended to work in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), when compared with placebo. The study will last approximately one year.",[346],"Pulmonary Disease, Chronic Obstructive",[348,349,350],"Emphysema","Chronic Bronchitis","Lung Disease",{"date":34,"type":37},{"date":353,"type":21},"2026-08",{"date":355,"type":21},"2028-11",{"name":304,"class":81},128,{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":58,"phases":367,"briefSummary":368,"conditions":369,"keywords":370,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":381},"100645337","phase-3-study-of-izalontamab-brengitecan-bms-986507-in-combination-with-osimertinib-versus-osimertinib-monotherapy-or-osimertinib-in-combination-with-platinum-based-chemotherapy-for-egfrmt-non-small-cell-lung-cancer-izabright-lung02-100645337","NCT07680790","Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)","A Phase III, Randomized, Open-label Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy as First-Line Therapy in Patients With EGFR-Mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB\u002FIIIC), metastatic (Stage IVA\u002FIVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatment\n* Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution)\n* Participants must have measurable extracranial disease per RECIST v1.1 as assessed by the investigator\n* Participants must have ECOG Performance Status 0-1\n\nExclusion Criteria:\n\n* Participants must not have unstable, symptomatic, or uncontrolled CNS metastases, including brain, leptomeningeal disease, and\u002For spinal cord compression\n* Participants must not have history of ILD\u002Fpneumonitis requiring treatment with steroids (≥ Grade 2), or current or suspected ILD\u002Fpneumonitis\n* Participants must not have clinically significant cardiac disease\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":366,"type":21},850,[61],"The purpose of this study is to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy",[95],[134,371,372,103,99,373,374],"EGFR","First line","ADC","IZABRIGHT-Lung02",{"date":34,"type":37},{"date":377,"type":21},"2026-09-30",{"date":379,"type":21},"2031-12-30",{"name":115,"class":81},208,{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":54,"minAge":389,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":58,"phases":392,"briefSummary":393,"conditions":394,"keywords":397,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":408},"100611500","phase-3-a-study-of-orforglipron-ly3502970-on-cardiovascular-outcomes-in-adults-with-atherosclerotic-cardiovascular-disease-andor-chronic-kidney-disease-attain-outcomes-100611500","NCT07241390","A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease (ATTAIN-Outcomes)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease","Inclusion Criteria:\n\n* Have established ASCVD and\u002For CKD\n\nExclusion Criteria:\n\n* Have type 1 diabetes\n* Have had a major heart condition within 60 days prior to screening\n* Have New York Heart Association Functional Classification Class IV heart failure","50 Years",{"count":391,"type":21},7140,[61],"The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and\u002For chronic kidney disease (CKD). Participation in the study will last about 5 years.",[395,396],"Atherosclerosis Cardiovascular Disease","Chronic Kidney Disease",[398,399,400,401],"Heart Disease","Kidney Disease","Outcomes","Stroke",{"date":34,"type":37},{"date":404,"type":37},"2025-12-01",{"date":406,"type":21},"2031-08",{"name":304,"class":81},567,{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":416,"sex":54,"minAge":417,"maxAge":418,"enrollmentInfo":419,"targetDuration":4,"studyType":58,"phases":421,"briefSummary":422,"conditions":423,"keywords":425,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":434},"100605263","phase-3-beatrix-a-study-to-learn-about-a-group-b-streptococcus-vaccine-in-healthy-pregnant-women-and-their-babies-100605263","NCT07160244","BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies","A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY PREGNANT WOMEN AND THEIR INFANTS","Key Inclusion criteria- Maternal:\n\n* Healthy pregnant women ≤49 years of age who are between 24 0\u002F7 and 36 0\u002F7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and who have no known increased risk of complications.\n* Had a fetal anomaly ultrasound examination with no significant fetal abnormalities observed.\n* Documented negative human immunodeficiency virus (HIV) antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization.\n* Capable of giving personal signed informed consent.\n* Willing to give informed consent for her infant to participate in the study.\n\nKey Exclusion criteria- Maternal:\n\n* Prepregnancy body mass index (BMI) of \\>40 kg\u002Fm2.\n* Current pregnancy complications or abnormalities that may increase the risk associated with the participation in and completion of the study.\n* Prior pregnancy complications or abnormalities that, based on the investigator's judgment, may increase the risk associated with the participation in and completion of the study.\n* History of microbiologically proven invasive disease caused by GBS in the current pregnancy.\n* A known or suspected infection during the current pregnancy that may increase the risk of complications in pregnancy (eg, active tuberculosis, syphilis, primary genital herpes simplex, malaria).\n\nKey Inclusion criteria- Infant Participants\n\n\\- Evidence of a signed and dated ICD signed by the parent(s)\u002Flegally authorized representative or legal guardian\n\nKey Exclusion Criteria - Infant Participants:\n\n\\- Children or grandchildren who are direct descendants of investigator site staff or sponsor and sponsor delegate employees directly involved in the conduct of the study.\n\nKey Exclusion Criteria - Infant immunogenicity subset Participants:\n\n\\- Children with a known or suspected contraindication to any vaccine administered in the infant vaccine immunogenicity subset.\n\nRefer to the study contact for further eligibility details",true,"1 Day","49 Years",{"count":420,"type":21},6000,[61],"BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies.\n\nThis study is seeking healthy pregnant participants:\n\n* aged 49 or younger who can join.\n* between 24 and 36 weeks of gestation (\"Gestational age\" is a medical term used to describe how far along your pregnancy is)\n* had a fetal ultrasound examination performed with no major fetal abnormalities observed\n* documented negative for HIV, syphilis and Hepatitis B All participants in this study will receive only 1 shot in an arm. This could either be a group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) or placebo. Placebo is an inactive substance used in the study for comparison purposes; in this study, the placebo injection will be saline (saltwater). The pregnant participants may take part in this study for a maximum of 14 months (6 months after delivery) , and their babies for about 12 months after they are born. The pregnant participants will need to visit the research site at least 3 to 4 times with some visits permitted to occur over the telephone.\n\nA subset of infants will be asked to take part in the study for up to 19 months. The subset will receive diphtheria toxoid-containing vaccine and\u002For pneumococcal vaccine following each country's standard immunization plan and have blood drawn 1 month after completion of the primary and\u002For toddler (booster) doses.",[424],"Healthy",[426],"group B streptococcus, maternal immunization, vaccine",{"date":34,"type":37},{"date":429,"type":37},"2025-08-25",{"date":431,"type":21},"2029-03-02",{"name":433,"class":81},"Pfizer",206,{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":58,"phases":444,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":448,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":455},"100603521","phase-2-a-study-to-assess-the-efficacy-and-safety-of-ro7790121-in-participants-with-moderate-to-severe-rheumatoid-arthritis-who-have-not-responded-to-or-who-cannot-tolerate-tumor-necrosis-factor-tnf-andor-janus-kinase-jak-inhibitors-100603521","NCT07137598","A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and\u002For Janus Kinase (JAK Inhibitors)","A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response or Intolerance to TNF and\u002For JAK Inhibitors","Inclusion Criteria:\n\n* Has moderate to severe active RA defined by the presence of \\>=6 swollen joints and \\>=6 tender joints at screening and baseline (based on 66\u002F68-joint count)\n* Diagnosis of RA for \\>=3 months and also fulfills the 2010 American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) classification criteria for RA\n* Demonstrated an inadequate response or loss of response to or intolerance to \\>=1 conventional synthetic disease-modifying antirheumatic drug (csDMARD)\n\nExclusion Criteria:\n\n* Have failed more than two TNF inhibitors or JAK inhibitors\n* Class IV RA according to ACR revised response criteria (Hochberg et al. 1992)\n* Past or current use of other biologic disease-modifying antirheumatic drugs (bDMARDs) (excluding TNF inhibitors) or rituximab\n* Treatment with investigational therapy within 4 weeks or within 5 half-lives of the investigational therapy, whichever is longer, prior to initiation of study treatment.\n* History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA\n* Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 weeks prior to the first dose of study drug\n* History of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of the study drug (or its excipients) and\u002For other products in the same class\n* Any major surgery within 6 weeks prior to screening or a major surgery planned during the study\n* Any serious, chronic and\u002For unstable pre-existing medical, psychiatric, or other- condition\n* History of malignancy, with the exception non-metastatic basal cell or cutaneous squamous cell cancer adequately treated with electrodesiccation and curettage or resection or in situ cervical cancer adequately treated and cured\n* Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections\n* History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection\n* History of organ transplant\n* Any identified confirmed congenital or acquired immunodeficiency\n* Abnormal laboratory values and liver function test",{"count":443,"type":21},160,[60],"This study will assess the efficacy and safety of Afimkibart (also known as RO7790121) compared with placebo in participants with moderate to severe rheumatoid arthritis (RA) who have an inadequate response or intolerance to TNF and\u002For JAK inhibitors.",[447],"Rheumatoid Arthritis",{"date":36,"type":37},{"date":450,"type":37},"2025-12-05",{"date":452,"type":21},"2027-10-02",{"name":454,"class":81},"Hoffmann-La Roche",63,{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":416,"sex":54,"minAge":463,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":58,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":478},"100596349","a-clinical-study-of-mk-8527-to-prevent-human-immunodeficiency-virus-type-1-hiv-1-mk-8527-011-100596349","NCT07044297","A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)","A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Is confirmed HIV-uninfected based on negative HIV-1\u002FHIV-2 test results\n* Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person\n* Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening\n* Weighs ≥35 kg\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has hypersensitivity or other contraindication to any component of the study interventions\n* Has evidence of acute or chronic hepatitis B infection\n* Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers\n* Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time\n* Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration\n* Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1\n* Is expecting to donate eggs at any time during the study","16 Years",{"count":465,"type":21},4390,[61],"Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection.\n\nThe goals of this study are to learn:\n\n* If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day\n* About the safety of MK-8527 and if people tolerate it",[469,470],"Human Immunodeficiency Virus (HIV)","HIV Pre-Exposure Prophylaxis",{"date":34,"type":37},{"date":473,"type":37},"2025-07-31",{"date":475,"type":21},"2027-07-22",{"name":477,"class":81},"Merck Sharp & Dohme LLC",81,{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":58,"phases":488,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":493,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":500},"100596280","phase-3-a-study-to-investigate-tislelizumab-administered-as-subcutaneous-injection-versus-intravenous-infusion-plus-chemotherapy-in-patients-with-unresectable-or-metastatic-gastric-or-gastroesophageal-junction-adenocarcinoma-100596280","NCT07043400","A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","A Phase 3, Multi-Center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Histologically confirmed, locally advanced unresectable or metastatic gastric\u002F gastroesophageal junction (GEJ) adenocarcinoma.\n* No previous systemic therapy for locally advanced unresectable or metastatic gastric\u002FGEJ cancer.\n* At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment.\n* Must be able to provide tumor tissues for biomarker assessment.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1.\n* Adequate organ function.\n* Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and ≥ 120 days after the last dose of tislelizumab.\n* Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab.\n\nExclusion Criteria:\n\n* Squamous cell or undifferentiated or other histological type gastric cancer (GC)\n* Active leptomeningeal disease or uncontrolled brain metastasis. Patients with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for ≥ 4 weeks before randomization.\n* Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2).\n* Active autoimmune diseases or history of autoimmune diseases that may relapse.\n* Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and\u002For diuretics within 7 days prior to randomization\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":487,"type":21},351,[61],"This study is designed to assess the levels of drug exposure following treatment with tislelizumab administered as a subcutaneous (SC) injection compared to intravenous infusion (IV) as first-line therapy in adults with gastric or gastroesophageal junction (GEJ) that is locally advanced and cannot be surgically removed or has spread from the stomach to other areas of the body. Approximately 351 patients will be participating in this study. The study is composed of a screening period, a treatment period, and a follow-up period.",[491,492],"Metastatic Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma",{"date":34,"type":37},{"date":495,"type":37},"2025-08-27",{"date":497,"type":21},"2028-04-22",{"name":499,"class":81},"BeOne Medicines",95,{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":58,"phases":510,"briefSummary":511,"conditions":512,"keywords":514,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":533,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":539},"100593979","a-study-to-learn-about-the-study-medicine-ibuzatrelvir-in-adults-with-covid-19-who-are-severely-immunocompromised-100593979","NCT07013474","A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised","AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE IBUZATRELVIR IN ADULTS WITH SYMPTOMATIC COVID-19 WHO ARE SEVERELY IMMUNOCOMPROMISED","Inclusion Criteria:\n\n1. 18 years of age or older at screening who are non-hospitalized or hospitalized with mild to moderate COVID-19\n2. Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test) collected within 2 days prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization.\n3. Severely immunocompromised due to:\n\n   * Solid organ or islet cell transplant recipient who is receiving immunosuppressive therapy;\n   * Active hematologic malignancy (eg, chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia);\n   * Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or who are receiving immunosuppressive therapy;\n   * Currently receiving or recently received B-cell depleting therapies (eg, rituximab), where the immunosuppressive effect is still ongoing.\n\nExclusion Criteria:\n\n1. Severe or critical COVID-19, or current need for supplemental oxygen.\n2. Receiving dialysis or have current kidney failure (ie, eGFR consistently \\\u003C15 mL\u002Fmin)\n3. Active liver disease\n4. History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator\n5. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.\n6. Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator.\n7. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n8. Has received any other antiviral for the treatment of the current COVID-19 infection\n9. Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).\n10. Current or previous administration of an investigational product (drug or vaccine) within 30 days (or as determined by local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Authorized or products with conditional approval are not considered investigational.\n11. Prior participation in this trial or any clinical trial of ibuzatrelvir.\n12. Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study.\n13. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.",{"count":509,"type":21},300,[61],"This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy, superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in combination with remdesivir IV compared to remdesivir IV alone for the treatment of symptomatic COVID-19 in severely immunocompromised adult participants who are non-hospitalized or are hospitalized at baseline with mild-to-moderate COVID-19.",[513],"COVID-19 Infection",[515,516,517,518,519,520,521,522,523,524,525,526,527,528,529,530,531,532],"COVID-19 infection","pneumonia","respiratory tract infections","coronavirus infection","RNA virus infection","lung disease","pneumonia, viral","infections","virus","viral protease inhibitor","protease inhibitor","enzyme inhibitor","severe immunocompromise","anti-viral agents","anti-infectives","ibuzatrelvir","remdesivir","COVID-19",{"date":36,"type":37},{"date":535,"type":37},"2025-07-14",{"date":537,"type":21},"2028-02-25",{"name":433,"class":81},152,{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":546,"eligibilityCriteria":547,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":340,"enrollmentInfo":548,"targetDuration":4,"studyType":58,"phases":550,"briefSummary":551,"conditions":552,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":557,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":564},"100593896","phase-2-a-study-of-long-acting-antibodies-alone-and-in-combinations-for-moderate-to-severe-ulcerative-colitis-100593896","NCT07012395","A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis","Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis","SKYLINE-UC","Inclusion Criteria:\n\n* Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening\n* Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)\n* Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2\n\nExclusion Criteria:\n\n* Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined\n* Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and\u002For other conditions that will likely require surgery during induction\n* Failed 4 or more approved or investigational advanced therapy classes",{"count":549,"type":21},645,[60],"This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.",[553,554,555,556],"Ulcerative Colitis","Inflammatory Bowel Diseases","Colitis","Colitis, Ulcerative",{"date":36,"type":37},{"date":559,"type":37},"2025-05-27",{"date":561,"type":21},"2028-03",{"name":563,"class":81},"Spyre Therapeutics, Inc.",267,{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":571,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":58,"phases":575,"briefSummary":576,"conditions":577,"keywords":578,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":580,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":586},"100592970","phase-3-a-phase-iii-study-of-azd0780-on-major-adverse-cv-events-in-patients-with-a-history-of-ascvd-events-or-at-high-risk-for-a-first-event-100592970","NCT07000357","A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event","A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event","AZURE-Outcomes","Inclusion Criteria:\n\n* Meets one of the following:\n\n  1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening\n\n     Additional risk factors based on the level of the LDL-C and timing of MI or stroke:\n\n     o Participants with an LDL-C ≥ 75 mg\u002FdL (≥ 1.9 mmol\u002FL) need to have at least one of the other additional risk factors (i to viii) below.\n\n     ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD\n  2. Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg\u002FdL (≥ 2.6 mmol\u002FL), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii):\n\n  (i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases:\n  1. Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin\u002Fcreatinine ratio ≥ 30 mg\u002Fg) and\u002For persistent eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening\n  2. Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist\n  3. Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist\n  4. ABI \\\u003C 0.9 or \\> 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance\n\n     For (ii) and (iii), participants need to have at least one of the additional risk factors below:\n\n  \u003C!-- -->\n\n  1. CKD with eGFR x mL\u002Fmin\u002F1.73 m2\n  2. Current tobacco use\n  3. Age ≥ 65\n  4. T2DM (if included on the less significant atherosclerosis criterion iii)\n* Participants should receive a background lipid lowering regimen anticipated to achieve at least a \\~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and\u002For bempedoic acid).\n\nParticipants must achieve a stable background lipid lowering therapy \\> 28 days before screening.\n\nExclusion criteria:\n\n* Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.\n* Any revascularisation procedure planned within the next 3 months.\n* Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.\n* Calculated eGFR \\\u003C 15 mL \u002Fmin\u002F1.73 m2 at screening.\n* Any laboratory values with the following deviations at screening:\n\n  * AST or ALT \\> 3 × ULN\n  * TBL \\> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \\\u003C 1.5 × ULN)\n  * Fasting triglycerides ≥ 400 mg\u002FdL (≥ 4.52 mmol\u002FL).\n  * Creatine kinase \\> 5 × ULN\n  * Urine albumin\u002Fcreatinine ratio ≥ 500 mg\u002Fg\n* Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.\n* Inadequately treated hypothyroidism defined as TSH \\> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.\n* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.\n* Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.\n* Use of PCSK9 inhibitors: evolocumab\u002Falirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.",{"count":574,"type":21},15100,[61],"The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.",[286],[579],"Atherosclerotic Cardiovascular Disease",{"date":34,"type":37},{"date":582,"type":37},"2025-06-04",{"date":584,"type":21},"2029-10-26",{"name":329,"class":81},1452,{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":593,"eligibilityCriteria":594,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":595,"targetDuration":4,"studyType":58,"phases":597,"briefSummary":598,"conditions":599,"keywords":602,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":603,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":609},"100581158","phase-3-a-study-of-bgb-16673-compared-to-investigators-choice-in-participants-with-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma-previously-exposed-to-both-bruton-tyrosine-kinase-btk-and-b-cell-leukemialymphoma-2-protein-bcl2-inhibitors-100581158","NCT06846671","A Study of Tacabrutideg (BGB-16673) Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia\u002FLymphoma 2 Protein (BCL2) Inhibitors","A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors","CaDAnCe-302","Inclusion Criteria:\n\n1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.\n2. Previously received treatment for CLL\u002FSLL with both a BTKi and a BCL2i.\n3. Participants with SLL must have measurable disease by computer tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2\n5. Adequate liver function\n6. Adequate blood clotting function\n\nExclusion Criteria:\n\n1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation\n2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months\n3. Known central nervous system involvement\n4. Prior exposure to any BTK protein degraders\n5. Active fungal, bacterial and\u002For viral infection requiring parenteral systemic therapy\n6. Clinically significant cardiovascular disease\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":596,"type":21},250,[61],"The purpose of this study is to investigate the efficacy and safety of tacabrutideg compared with investigator's choice (idelalisib plus rituximab \\[for CLL only\\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).",[600,601],"CLL","Chronic Lymphocytic Leukemia",[600],{"date":34,"type":37},{"date":605,"type":37},"2025-04-10",{"date":607,"type":21},"2030-02-14",{"name":499,"class":81},130,{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":615,"acronym":616,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":618,"targetDuration":4,"studyType":58,"phases":619,"briefSummary":620,"conditions":621,"keywords":624,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":631,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":638},"100574886","phase-3-neladalkib-nvl-655-for-tki-naive-patients-with-advanced-alk-positive-nsclc-100574886","NCT06765109","Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC","A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)","ALKAZAR","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)\n2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood\n3. No prior systemic anticancer treatment for NSCLC (adjuvant\u002Fneoadjuvant chemotherapy allowed if 12 months prior to randomization; prior ALK tyrosine kinase inhibitor \\[TKI\\] such as alectinib is not allowed in any setting)\n4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1)\n5. Pretreatment tumor tissue\n\nExclusion Criteria:\n\n1. Patient's cancer has a known oncogenic driver alteration other than ALK.\n2. Known allergy\u002Fhypersensitivity to excipients of neladalkib or alectinib.\n3. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization\n4. Major surgery within 4 weeks prior to randomization\n5. Uncontrolled clinically relevant infection requiring systemic therapy\n6. Known active tuberculosis, or active Hepatitis B or C\n7. QT corrected for heart rate by Fridericia's formula (QTcF) \\> 470 msec on repeated assessments\n8. Clinically significant cardiovascular disease\n9. Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease\n10. Active malignancy requiring therapy within 2 years prior to randomization",{"count":155,"type":21},[61],"Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).",[622,623],"Non-small Cell Lung Cancer","Anaplastic Lymphoma Kinase-positive",[134,133,625,626,627,628,629,630],"Lung neoplasms","Lung diseases","ALK positive NSCLC","TKI naive","ALK TKI naive","Treatment naive",{"date":36,"type":37},{"date":633,"type":37},"2025-07-17",{"date":635,"type":21},"2029-12",{"name":637,"class":81},"Nuvalent Inc.",158,{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":4,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":646,"targetDuration":4,"studyType":58,"phases":648,"briefSummary":649,"conditions":650,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":653,"startDateStruct":654,"completionDateStruct":656,"leadSponsor":658,"locationsCount":659},"100569788","phase-3-a-study-to-understand-how-the-study-medicine-dazukibart-works-in-people-with-idiopathic-inflammatory-myopathies-100569788","NCT06698796","A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies","A PHASE 3, MULTI-CENTER, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF DAZUKIBART IN PARTICIPANTS WITH IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH DERMATOMYOSITIS OR POLYMYOSITIS)","Inclusion Criteria:\n\n* Participants that completed a qualifying study through Week 52.\n\nExclusion Criteria:\n\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation.\n* Previous administration with an investigational product (drug or vaccine) other than dazukibart in a qualifying study within 30 days (or as determined by the local requirement) or 5 half-lives preceding baseline in this study (whichever is longer).\n* Current use of any prohibited concomitant medication(s).\n* Active bacterial, viral, fungal, mycobacterial or other infections.\n* Ongoing adverse event in a qualifying study or the participant has met safety monitoring criteria in a qualifying study that have not resolved.\n* Investigator site staff or sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.",{"count":647,"type":21},211,[61],"The purpose of this study is to understand how the study medicine, dazukibart, works in people with active idiopathic inflammatory myopathies (dermatomyositis \\[DM\\] or polymyositis \\[PM\\]).\n\nIdiopathic inflammatory myopathies are a group of disorders that show inflammation of the muscles used for movement. There are several types of idiopathic inflammatory myopathies, including DM and PM.\n\nDM and PM involve weakness of the muscles closest to the center of the body, such as the muscles of the hips, thighs, upper arms, and neck. People with these forms of idiopathic inflammatory myopathies may find it difficult to climb stairs, get up from a seated position, or lift items above their head. People with DM can also have a skin rash.\n\nThese disorders negatively impact the quality of life and functioning of patients. In addition to the above, these disorders can affect how the lungs and heart work.\n\nThis study is seeking participants who took part in a DM and PM study with dazukibart before. Some participants will receive study medicine, and some participants will not receive study medicine and only complete safety follow-up.\n\nThe study medicine will be given as an intravenous (IV) infusion (directly into the veins). This takes about 1 hour, every 4 weeks, from Day 1 to Week 48 (about 12 months) of the study. This will be followed by a safety follow-up period that lasts about 4 months after the last infusion. Participants who receive study medicine will have about 18 study visits at the site over about 16 months.\n\nThere will also be participants enrolled in this study who will not receive study medicine. Such participants will only take part in safety follow-up visits as they do not want to or are not eligible to receive dazukibart. These participants will not receive study medicine and will have up to 4 study visits at the site every 4 weeks to complete safety follow-up.",[651,652],"Dermatomyositis","Polymyositis",{"date":36,"type":37},{"date":655,"type":37},"2025-01-22",{"date":657,"type":21},"2031-07-29",{"name":433,"class":81},26,{"id":661,"slug":662,"hasResults":12,"nctId":663,"briefTitle":664,"officialTitle":665,"acronym":4,"eligibilityCriteria":666,"healthyVolunteers":12,"sex":54,"minAge":667,"maxAge":4,"enrollmentInfo":668,"targetDuration":4,"studyType":58,"phases":670,"briefSummary":671,"conditions":672,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":674,"startDateStruct":675,"completionDateStruct":677,"leadSponsor":678,"locationsCount":679},"100542140","phase-3-a-study-of-lebrikizumab-ly3650150-in-participants-with-chronic-rhinosinusitis-and-nasal-polyps-treated-with-intranasal-corticosteroids-contrast-np-100542140","NCT06338995","A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)","A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab\u002FLY3650150 in Participants With Chronic Rhinosinusitis With Nasal Polyps on Background Intranasal Corticosteroids","Inclusion Criteria:\n\n* Physician-diagnosed chronic rhinosinusitis (CRS) with bilateral nasal polyps (NP).\n* Prior treatment with systemic corticosteroids (SCS) within the last 2 years (or a medical contraindication or intolerance to SCS), prior surgery for NP, or both.\n* Endoscopic bilateral NPS score of at least 5 out of 8, with a minimum score of 2 in each nasal cavity performed at screening and baseline.\n* Ongoing symptoms for at least 8 weeks prior to study entry (screening), including:\n\n  1. Nasal congestion with moderate or severe symptom severity (score 2 or 3) at screening and a weekly average severity score of at least 1 (range 0 to 3) at randomization, and\n  2. At least one other symptom, such as partial loss of smell (hyposmia), total loss of smell (anosmia), or anterior or posterior rhinorrhea.\n* Have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.\n* Adolescent participants ≥12 to \\\u003C18 years of age and weighing ≥40 kg at time of Visit 1.\n\nExclusion Criteria:\n\n* Have received a dose of lebrikizumab.\n* Have received treatment with any rescue medication and\u002For have the need for surgery for NP during screening and\u002For run-in period.\n* Allergen immunotherapy (subcutaneous immunotherapy \\[SCIT\\]\u002Fsublingual immunotherapy \\[SLIT\\]) initiated within 6 months prior to screening, that is not on a stable dose (3 months prior to screening).\n* Has received a biologic treatment approved for use in CRSwNP, asthma, or AD, even if administered to treat a different condition, within 4 months or 5 half-lives, whichever is longer, prior to screening.\n* Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit:\n\n  1. B cell-depleting biologics, including rituximab, within 6 months.\n  2. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.\n  3. Systemic immunosuppressants within 4 weeks prior to baseline.\n* Have had any sinus intranasal surgery (including nasal polypectomy) within 6 months prior to screening\n* Have had prior sino-nasal surgery or sinus surgery changing lateral wall structure of the nose making it difficult to assess endoscopic NPS\n* Have a presence of any of the following conditions that may impact the assessment of endpoints at screening or baseline:\n\n  1. Nasal septal deviation occluding at least one nostril.\n  2. Antrochoanal polyps.\n  3. Acute sinusitis, acute nasal infection, or acute upper respiratory infection.\n  4. Ongoing rhinitis medicamentosa.\n  5. Presence of another diagnosis associated with NP (ie, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young's syndrome, primary ciliary dyskinesia, cystic fibrosis). Note: for adolescents, documentation for ruling out cystic fibrosis and primary ciliary dyskinesia is required.\n  6. A nasal cavity tumor (malignant or benign).\n  7. Evidence of fungal rhinosinusitis.\n* Have anosmia from COVID or any reason other than CRSwNP.\n* Participants with forced expiratory volume in 1 second (FEV1) 50% or less (of predicted normal) at screening.\n* Female participant who is pregnant, breastfeeding, or is planning to become pregnant, or to breastfeed during the study.","12 Years",{"count":669,"type":21},510,[61],"The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.",[673],"Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)",{"date":34,"type":37},{"date":676,"type":37},"2024-04-29",{"date":561,"type":21},{"name":304,"class":81},202,{"id":681,"slug":682,"hasResults":12,"nctId":683,"briefTitle":684,"officialTitle":685,"acronym":4,"eligibilityCriteria":686,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":687,"targetDuration":4,"studyType":58,"phases":689,"briefSummary":690,"conditions":691,"keywords":693,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":710,"startDateStruct":711,"completionDateStruct":713,"leadSponsor":715,"locationsCount":716},"100527808","phase-3-magnetismm-32-a-study-to-learn-about-the-study-medicine-called-elranatamab-in-people-with-multiple-myeloma-mm-that-has-come-back-after-taking-other-treatments-including-prior-treatment-with-an-anti-cd38-antibody-and-lenalidomide-100527808","NCT06152575","MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)","A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED\u002FREFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY","Inclusion Criteria:\n\n* Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.\n* Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.\n* Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g\u002FdL; (b) Urinary M-protein excretion ≥200 mg\u002F24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg\u002FdL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\\\u003C0.26 or \\>1.65).\n* Have clinical laboratory values within the specified range.\n* ECOG (Eastern Cooperative Oncology Group) performance status ≤2.\n* Not pregnant or breastfeeding and willing to use contraception.\n\nExclusion Criteria:\n\n* Smoldering multiple myeloma.\n* Plasma cell leukemia.\n* Amyloidosis.\n* Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.\n* Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.\n* Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.\n* Any active, uncontrolled bacterial, fungal, or viral infection.\n* Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)\n* Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.\n* Unable to receive investigator's choice therapy.\n* Live attenuated vaccine within 4 weeks of the first dose of study intervention.\n* Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.",{"count":688,"type":21},492,[61],"The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer).\n\nThis study is seeking participants who:\n\n* Are 18 years of age or older and have MM.\n* Have received treatments before for MM.\n* Have MM that has returned or not responded to their most recent treatment.\n\nHalf of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM.\n\nElranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study.\n\nThe medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as:\n\n* a shot under the skin at the study clinic\n* through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects.\n\nParticipants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits).\n\nThe study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.",[692],"Multiple Myeloma",[694,695,696,697,698,699,700,701,702,703,704,705,706,707,708,709],"Elranatamab","B-Cell Maturation Antigen","BCMA","Bispecific antibody","BCMA-CD3 bispecific antibody","Myeloma","Multiple myeloma","Relapsed multiple myeloma","Refractory multiple myeloma","MagnetisMM","MagnetisMM-32","Pomalidomide","Elotuzumab","Bortezomib","Carfilzomib","PF-06863135",{"date":34,"type":37},{"date":712,"type":37},"2024-02-08",{"date":714,"type":21},"2027-12-30",{"name":433,"class":81},270,""]