A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

NCT03470922 · tracked via the Priya Life Science UK tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 2/3

Started

2018-04-11

Last updated

2025-09-09

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

RelatlimabNivolumab

Relatlimab: Specified dose on specified day

Nivolumab: Specified dose on specified days

Study summary

The purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab monotherapy in treating unresectable melanoma or melanoma that has spread.

Eligibility

Sex

ALL

Min age

12 Years

Max age

—

Healthy volunteers

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system * Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma * Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses Exclusion Criteria: * Participants must not have active brain metastases or leptomeningeal metastases * Participants must not have uveal melanoma * Participants must not have an active, known, or suspected autoimmune disease Other protocol defined inclusion/exclusion criteria could apply

Primary outcome measure(s)

Progression Free Survival (PFS) — From randomization to date of first documented tumor progression or death (up to approximately 33 months)
Progression Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented tumor progression, assessed by a blinded independent central review (BICR) (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death.

Trial sites (127)

Facility	City	Region
Local Institution - 0010	Tucson	Arizona
Local Institution - 0020	Los Angeles	California
Coastal Integrative Cancer Care	San Luis Obispo	California
Local Institution - 0116	Santa Barbara	California
Local Institution - 0012	Washington D.C.	District of Columbia
Local Institution - 0013	Jacksonville	Florida
Local Institution - 0117	Orlando	Florida
Local Institution - 0007	Tampa	Florida
Local Institution - 0038	Atlanta	Georgia
Local Institution - 0016	Chicago	Illinois
Local Institution - 0114	Fort Wayne	Indiana
Local Institution - 0077	Baltimore	Maryland
Local Institution - 0120	Baltimore	Maryland
Local Institution - 0014	Boston	Massachusetts
Local Institution - 0134	Boston	Massachusetts
Local Institution - 0015	Ann Arbor	Michigan
Local Institution - 0009	Minneapolis	Minnesota
Local Institution - 0011	Rochester	Minnesota
Local Institution - 0018	Charlotte	North Carolina
Local Institution - 0019	Allentown	Pennsylvania
Local Institution - 0076	Dallas	Texas
Local Institution - 0008	Houston	Texas
Local Institution - 0135	Buenos Aires	Distrito Federal
Local Institution - 0002	Capital Federal	Distrito Federal
Local Institution - 0004	Buenos Aires	Argentina
Local Institution - 0003	Buenos Aires	Argentina
Local Institution - 0005	Buenos Aires	Argentina
Local Institution - 0042	North Sydney	New South Wales
Local Institution - 0043	Waratah	New South Wales
Local Institution - 0041	Greenslopes	Queensland
Local Institution - 0045	Southport	Queensland
Local Institution - 0133	Bedford Park	South Australia
Local Institution - 0044	Murdoch	Western Australia
Local Institution - 0036	Graz	Styria
Local Institution - 0037	Salzburg	Austria
Local Institution - 0035	Vienna	Austria
Local Institution - 0047	Brussels	Belgium
Local Institution - 0049	Brussels	Belgium
Local Institution - 0048	Ghent	Belgium
Local Institution - 0058	Belo Horizonte	Minas Gerais

+ 87 more sites — see the full list on the official registry below.

On this site

📄 Opdivo (nivolumab) drug profile →

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Other trials for the same condition

Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma. Recruiting

A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001) Active, not recruiting

A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition Active, not recruiting

Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. Active, not recruiting

Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03470922 on ClinicalTrials.gov ↗ ← All trials in the UK