A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma (RELATIVITY-047)

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Melanoma

Treatments: Biological: Nivolumab; Biological: Relatlimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03470922

CA224-047

2017-003583-12 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 714 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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714 participants in 2 patient groups

Arm A: Relatlimab + Nivolumab

Experimental group

Description:

Combination

Treatment:

Biological: Relatlimab

Biological: Nivolumab

Arm B: Nivolumab

Experimental group

Description:

Monotherapy

Treatment:

Biological: Nivolumab