A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

Phase 3Active Not RecruitingNCT03470922

Bristol-Myers Squibb714 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

714

Conditions

Melanoma

Interventions

RelatlimabBIOLOGICAL

Specified dose on specified day

NivolumabBIOLOGICAL

Specified dose on specified days

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (127)

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

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.

Time frame: From randomization to date of first documented tumor progression or death (up to approximately 33 months)

Secondary Outcomes

Overall Survival (OS)

Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For subjects that are alive, their survival time will be censored at the date of last contact ("last known alive date").

Time frame: From randomization to the date of death (up to approximately 3 years)

Overall Response Rate (ORR)

Objective response rate (ORR) is defined as the number of randomized subjects who achieve a best response of complete response (CR) or partial response (PR) based on BICR assessments (using RECIST v1.1 criteria).

Time frame: From randomization up to approximately 3 years

Data from ClinicalTrials.gov

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Local Institution - 0010

Tucson, Arizona, United States

Local Institution - 0020

Los Angeles, California, United States

Coastal Integrative Cancer Care

San Luis Obispo, California, United States

Local Institution - 0116

Santa Barbara, California, United States

Local Institution - 0012

Washington D.C., District of Columbia, United States

Local Institution - 0013

Jacksonville, Florida, United States

Local Institution - 0117

Orlando, Florida, United States

Local Institution - 0007

Tampa, Florida, United States

Local Institution - 0038

Atlanta, Georgia, United States

Local Institution - 0016

Chicago, Illinois, United States

...and 117 more locations