Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-01 @ 12:54 PM
Study NCT ID:
NCT05002569
Status:
TERMINATED
Last Update Posted:
2025-05-18
First Post:
2021-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma
Sponsor:
Organization:
Raw JSON
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'Nivolumab'}, {'id': 'C000721227', 'term': 'relatlimab'}, {'id': 'C000729737', 'term': 'Opdualag'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1190}}, 'statusModule': {'whyStopped': 'Inability to meet protocol objectives', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT05170685', 'statusForNctId': 'NO_LONGER_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2021-08-04', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence-Free Survival (RFS) time per Investigator assessment', 'timeFrame': 'Approximately 52 months'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Approximately 90 months'}, {'measure': 'Distant Metastasis-Free Survival (DMFS) time per Investigator assessment', 'timeFrame': 'Approximately 90 months'}, {'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': "30 days from participant's last dose"}, {'measure': 'Severity of AEs', 'timeFrame': "30 days from participant's last dose"}, {'measure': 'Incidence of Serious Adverse Events (SAEs)', 'timeFrame': "30 days from participant's last dose"}, {'measure': 'Severity of SAEs', 'timeFrame': "30 days from participant's last dose"}, {'measure': 'Incidence of AEs leading to discontinuation (DC)', 'timeFrame': "30 days from participant's last dose"}, {'measure': 'Severity of AEs leading to DC', 'timeFrame': "30 days from participant's last dose"}, {'measure': 'Incidence of immune-mediated AEs (IMAEs)', 'timeFrame': "135 days from participant's last dose"}, {'measure': 'Severity of IMAEs', 'timeFrame': "135 days from participant's last dose"}, {'measure': 'Incidence of drug related AEs', 'timeFrame': "30 days from participant's last dose"}, {'measure': 'Severity of drug related AEs', 'timeFrame': "30 days from participant's last dose"}, {'measure': 'Incidence of deaths', 'timeFrame': "30 days from participant's last dose"}, {'measure': 'Incidence of clinically significant changes in clinical laboratory values: Hematology tests', 'timeFrame': "30 days from participant's last dose"}, {'measure': 'Incidence of clinically significant changes in clinical laboratory values: Chemistry tests', 'timeFrame': "30 days from participant's last dose"}, {'measure': 'Progression-Free Survival 2 (PFS2)', 'timeFrame': 'Approximately 52 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Melanoma', 'Relatlimab', 'Nivolumab', 'Opdivo'], 'conditions': ['Melanoma']}, 'referencesModule': {'references': [{'pmid': '41109920', 'type': 'DERIVED', 'citation': 'Long GV, Garnett-Benson C, Dolfi S, Ascierto PA, Guo J, Tarhini AA, Chandra S, Munoz-Couselo E, Del Vecchio M, de Melo AC, Callahan M, Gogas H, Dummer R, Schadendorf D, Koelblinger P, Quereux G, Thomas I, Yu JX, Fisher A, Wang B, Djidel P, Chouzy A, Semaan M, Chen B, Cheong AMY, Tawbi HA. Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial. Nat Med. 2025 Dec;31(12):4301-4309. doi: 10.1038/s41591-025-04032-8. Epub 2025 Oct 18.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'http://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have been diagnosed with either Stage IIIA (\\> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible\n* Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Adolescent participants between 12 and \\< 18 years of age must have a Lansky/Karnofsky performance score ≥ 80%\n* Complete resection must be performed within 90 days prior to randomization\n* All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization\n* Tumor tissue must be provided for biomarker analyses\n\nExclusion Criteria:\n\n* History of ocular melanoma\n* Untreated/unresected CNS metastases or leptomeningeal metastases\n* Active, known, or suspected autoimmune disease\n* Participants with serious or uncontrolled medical disorder\n* Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted\n* Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening\n* History of myocarditis, regardless of etiology.\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT05002569', 'acronym': 'RELATIVITY-098', 'briefTitle': 'A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab + Relatlimab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma', 'orgStudyIdInfo': {'id': 'CA224-098'}, 'secondaryIdInfos': [{'id': '2021-001641-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Nivolumab Plus Relatlimab', 'description': 'Combination', 'interventionNames': ['Biological: Nivolumab + Relatlimab Fixed Dose Combination']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: Nivolumab', 'description': 'Monotherapy', 'interventionNames': ['Biological: Nivolumab']}], 'interventions': [{'name': 'Nivolumab', 'type': 'BIOLOGICAL', 'otherNames': ['Opdivo', 'BMS-936558'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Arm B: Nivolumab']}, {'name': 'Nivolumab + Relatlimab Fixed Dose Combination', 'type': 'BIOLOGICAL', 'otherNames': ['BMS-986213', 'Opdualag'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Arm A: Nivolumab Plus Relatlimab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution - 0176', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72762', 'city': 'Springdale', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Local Institution - 0164', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution - 0200', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution - 0185', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution - 0162', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': "Saint John's Cancer Institute", 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Local Institution - 0138', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Local Institution - 0166', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution - 0243', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Washington University School Of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution - 0179', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center, Richard M. 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