Description:
The purpose of this study is to determine whether nivolumab in combination with relatlimab 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 nivolumab in combination with relatlimab 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) |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Phase 3 portion of trial. Assessed by a Blinded Independent Central Review (BICR) |
Secondary Outcome Measures
| Measure: | Overall Survival (OS) |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Phase 3 portion of trial |
| Measure: | ORR |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Phase 3 portion of trial, assessed by a BICR |
| Measure: | ORR |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Phase 2 portion of trial, assessed by a BICR. In the randomized population and in subgroups |
| Measure: | Duration of Response (DOR) |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Phase 2 portion of trial. In the randomized population and in subgroups |
| Measure: | PFS |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Phase 2 portion of trial. In subgroups. |
| Measure: | OS |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Phase 2 portion of trial. In the randomized population and in subgroups |
| Measure: | Number of Adverse Events (AEs) |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Phase 2 portion of the trial |
| Measure: | Number of Serious Adverse Events (SAEs) |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Phase 2 portion of the trial |
| Measure: | Number of AEs Leading to Discontinuation |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Phase 2 portion of the trial |
| Measure: | Number of Deaths |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Phase 2 portion of the trial |
| Measure: | Number of Laboratory Abnormalities |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Phase 2 portion of the trial |
Details
| Phase: | Phase 2/Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Trial Keywords
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