A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma
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ClinicalTrials.gov Identifier: NCT03470922 |
Recruitment Status :
Recruiting
First Posted : March 20, 2018
Last Update Posted : September 1, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Melanoma | Biological: Relatlimab Biological: Nivolumab | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 700 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | April 10, 2018 |
Estimated Primary Completion Date : | May 24, 2021 |
Estimated Study Completion Date : | March 16, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A: Relatlimab + Nivolumab
Combination
|
Biological: Relatlimab
Specified dose on specified day Biological: Nivolumab Specified dose on specified days |
Experimental: Arm B: Nivolumab
Monotherapy
|
Biological: Nivolumab
Specified dose on specified days |
- Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]Phase 3 portion of trial. Assessed by a Blinded Independent Central Review (BICR)
- PFS [ Time Frame: Up to 5 years ]Phase 2 portion of trial, assessed by a BICR
- Overall Survival (OS) [ Time Frame: Up to 5 years ]Phase 3 portion of trial
- ORR [ Time Frame: Up to 5 years ]Phase 3 portion of trial, assessed by a BICR
- ORR [ Time Frame: Up to 5 years ]Phase 2 portion of trial, assessed by a BICR. In the randomized population and in subgroups
- Duration of Response (DOR) [ Time Frame: Up to 5 years ]Phase 2 portion of trial. In the randomized population and in subgroups
- PFS [ Time Frame: Up to 5 years ]Phase 2 portion of trial. In subgroups.
- OS [ Time Frame: Up to 5 years ]Phase 2 portion of trial. In the randomized population and in subgroups
- Number of Adverse Events (AEs) [ Time Frame: Up to 5 years ]Phase 2 portion of the trial
- Number of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]Phase 2 portion of the trial
- Number of AEs Leading to Discontinuation [ Time Frame: Up to 5 years ]Phase 2 portion of the trial
- Number of Deaths [ Time Frame: Up to 5 years ]Phase 2 portion of the trial
- Number of Laboratory Abnormalities [ Time Frame: Up to 5 years ]Phase 2 portion of the trial

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470922
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, | please email: | Clinical.Trials@bms.com | |
Contact: First line of the email MUST contain NCT # and Site #. |

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT03470922 |
Other Study ID Numbers: |
CA224-047 2017-003583-12 ( EudraCT Number ) |
First Posted: | March 20, 2018 Key Record Dates |
Last Update Posted: | September 1, 2020 |
Last Verified: | August 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Cancer Advanced Cancer |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Nivolumab Antineoplastic Agents, Immunological Antineoplastic Agents |