[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"untreated-melanoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:untreated-melanoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100628277","phase-4-a-study-to-assess-the-safety-and-tolerability-of-nivolumab--relatlimab-fixed-dose-combination-fdc-in-untreated-unresectable-or-metastatic-melanoma-participants-in-india-100628277",false,"NCT07459543","A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unresectable or Metastatic Melanoma Participants In India","A Phase 4, Single Arm, Open Label Study to Evaluate Safety, Tolerability, and Efficacy of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in Participants With Previously Untreated, Unresectable or Metastatic Melanoma in India.","Inclusion Criteria\n\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1\u002FLansky Performance Score ≥ 80% for minors (ages 12-17) ONLY.\n* Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) staging system (8th edition).\n* Participants must be treatment-naïve (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma).\n* Participants must have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.\n* Participants must have completed prior radiotherapy at least 2 weeks prior to study treatment administration.\n* Individuals of Childbearing Potential (IOCBP) must not be pregnant or breastfeeding.\n\nExclusion Criteria\n\n* Participants must not have active brain metastases or leptomeningeal metastases.\n* Participants must not have uveal melanoma.\n* Participants must not have an active, known, or suspected autoimmune disease.\n* Participants must not have a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment.\n* Participants must not have a history of myocarditis.\n* Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways. Prior treatment with relatlimab or any other with LAG-3 targeted agents.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","ALL","12 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","The purpose of this study is to assess the safety and tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in untreated, unresectable or metastatic melanoma participants in India",[26,27,28],"Untreated Melanoma","Unresectable Melanoma","Metastatic Melanoma",[30,31,32,33,34,35],"Skin Cancer","Malignant Melanoma","Immunotherapy","India","Nivolumab","Relatlimab","NOT_YET_RECRUITING","2026-03-05",{"date":39,"type":40},"2026-03-09","ACTUAL",{"date":42,"type":20},"2026-11-15",{"date":44,"type":20},"2029-05-28",{"name":46,"class":47},"Bristol-Myers Squibb","INDUSTRY",8]