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

Purpose

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.

Condition

  • Melanoma

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Nivolumab Plus Relatlimab 		Combination
  • Biological: Nivolumab + Relatlimab Fixed Dose Combination
    Specified dose on specified days
    Other names:
    • BMS-986213
    • Opdualag
Experimental
Arm B: Nivolumab 		Monotherapy
  • Biological: Nivolumab
    Specified dose on specified days
    Other names:
    • Opdivo
    • BMS-936558

More Details

Status
Active, not recruiting
Sponsor
Bristol-Myers Squibb

Study Contact