Description:
The purpose of this study is to determine whether relatlimab in combination with nivolumab is
more effective than nivolumab by itself in treating unresectable melanoma or melanoma that
has spread.
Title
- Brief Title: A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma
- Official Title: A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma
Clinical Trial IDs
- ORG STUDY ID:
CA224-047
- SECONDARY ID:
2017-003583-12
- NCT ID:
NCT03470922
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Relatlimab | | Arm A: Relatlimab + Nivolumab |
| Nivolumab | | Arm A: Relatlimab + Nivolumab |
Purpose
The purpose of this study is to determine whether relatlimab in combination with nivolumab is
more effective than nivolumab by itself in treating unresectable melanoma or melanoma that
has spread.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Arm A: Relatlimab + Nivolumab | Experimental | Combination | |
| Arm B: Nivolumab | Experimental | Monotherapy | |
Eligibility Criteria
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 12 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Progression Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
| Time Frame: | Up to approximately 32 months |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Overall Survival (OS) |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | |
| Measure: | Overall response rate (ORR) as assessed by BICR |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 2/Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Trial Keywords
Last Updated
July 14, 2021
