A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma
Overview
- Phase
- Phase 2
- Intervention
- Relatlimab
- Conditions
- Melanoma
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 714
- Locations
- 127
- Primary Endpoint
- Progression Free Survival (PFS)
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Arm A: Relatlimab + Nivolumab
Combination
Intervention: Relatlimab
Arm A: Relatlimab + Nivolumab
Combination
Intervention: Nivolumab
Arm B: Nivolumab
Monotherapy
Intervention: Nivolumab
Outcomes
Primary Outcomes
Progression Free Survival (PFS)
Time Frame: 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.
Secondary Outcomes
- Overall Response Rate (ORR)(From randomization up to approximately 3 years)
- Overall Survival (OS)(From randomization to the date of death (up to approximately 3 years))