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

TERMINATEDPHASE3

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

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

NCT05002569•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (184)

Local Institution - 0176

Birmingham, Alabama, United States

Local Institution - 0164

Springdale, Arkansas, United States

Local Institution - 0200

Los Angeles, California, United States

Local Institution - 0185

Palo Alto, California, United States

Local Institution - 0162

San Francisco, California, United States

Saint John's Cancer Institute

Santa Monica, California, United States

Local Institution - 0138

Aurora, Colorado, United States

Local Institution - 0166

Washington D.C., District of Columbia, United States

Local Institution - 0243

Miami, Florida, United States

Washington University School Of Medicine

Miami, Florida, United States

Key Dates

Start Date

October 19, 2021

Primary Completion Date

December 16, 2024

Completion Date

April 2, 2025

Last Updated

January 8, 2026

Enrollment

1,093

ACTUAL participants

Conditions

Melanoma

Interventions

Nivolumab

BIOLOGICAL

Nivolumab + Relatlimab Fixed Dose Combination

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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