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Active, Not Recruiting

A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma - CA224-098

Updated: 15 September, 2023   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 12+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Arm A: Nivolumab Plus Relatlimab
Biological: Nivolumab + Relatlimab Fixed Dose Combination
Experimental: Arm B: Nivolumab
Biological: Nivolumab

Key Eligibility Criteria

Inclusion Criteria: - 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 - 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% - Complete resection must be performed within 90 days prior to randomization - 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 - Tumor tissue must be provided for biomarker analyses Exclusion Criteria: - History of ocular melanoma - Untreated/unresected CNS metastases or leptomeningeal metastases - Active, known, or suspected autoimmune disease - Participants with serious or uncontrolled medical disorder - Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted - Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening - History of myocarditis, regardless of etiology. Other protocol-defined inclusion/exclusion criteria apply

If you want to report a side effect, you can report directly to the Danish Medicines Agency via the website www.meldenbivirkning.dk
We recommend that you also contact BMS to report side effects.
Side effects and other reportable events are defined here
Report side effects or product quality complaints: Medical Information

466-DK-2200001