CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 714 enrolled
Drug / intervention
Relatlimab +1 morebiological
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Histologically confirmed Stage III (unresectable) or Stage IV melanoma per AJCC staging
  • ✓No prior systemic anticancer therapy for unresectable or metastatic melanoma
  • ✓Tumor tissue from unresectable or metastatic site available for biomarker analyses
Key exclusion· 3
  • ✕Active brain metastases or leptomeningeal metastases
  • ✕Uveal melanoma
  • ✕Active, known, or suspected autoimmune disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03470922
NCT03470922Phase 3Active
CompareCT.gov

A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma

Bristol-Myers Squibb·interventional·Posted Mar 20, 2018·Updated Sep 9, 2025

In Brief

A Phase 3 clinical trial evaluating Relatlimab and Nivolumab for Melanoma. Active but no longer recruiting, targeting 714 participants across 127 sites in 25 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Mexico, New Zealand, Norway, Poland, Romania, Russia, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3Active
20182019202020212022202320242025202620272028202920302031
First PostedMar 20, 2018
Enrollment StartApr 11, 2018
Primary CompletionJan 25, 2021
Study CompletionDec 15, 2030
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.3 years ago

Interventions

Relatlimabbiological

Specified dose on specified day

Nivolumabbiological

Specified dose on specified days