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

Stopped early · Phase 3

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT05002569

Run by

Bristol-Myers Squibb

People needed

1093

Starts

2021-10-19

Expected to finish

2025-04-02

Last updated by the study team

2026-01-08

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Local Institution - 0179 — Pensacola, Florida, United States
• Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center — Tampa, Florida, United States
• Local Institution - 0191 — Atlanta, Georgia, United States
• Local Institution - 0148 — Atlanta, Georgia, United States
• Local Institution - 0202 — Chicago, Illinois, United States
• Local Institution - 0177 — Peoria, Illinois, United States
• Local Institution - 0223 — Fort Wayne, Indiana, United States
• University of Iowa-Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
• Local Institution - 0178 — Westwood, Kansas, United States
• Dana-Farber Cancer Institute-Melanoma — Boston, Massachusetts, United States
• Local Institution - 0258 — Ann Arbor, Michigan, United States
• Local Institution — Grand Rapids, Michigan, United States
• Local Institution - 0133 — Minneapolis, Minnesota, United States
• Local Institution - 0139 — Hackensack, New Jersey, United States
• Local Institution - 0201 — Barcelona, Spain

Full record on ClinicalTrials.gov

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