A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unresectable or Metastatic Melanoma Participants In India

March 5, 2026 updated by: Bristol-Myers Squibb

A Phase 4, Single Arm, Open Label Study to Evaluate Safety, Tolerability, and Efficacy of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in Participants With Previously Untreated, Unresectable or Metastatic Melanoma in India.

The purpose of this study is to assess the safety and tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in untreated, unresectable or metastatic melanoma participants in India

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • India
      • Chennai, India, 600006
        • Local Institution - 0002
        • Contact:
          • Site 0002
      • Mumbai, India, 400 012
        • Local Institution - 0006
        • Contact:
          • Site 0006
      • Nagpur, India, 440001
        • Local Institution - 0005
        • Contact:
          • Site 0005
      • New Delhi, India, 110029
        • Local Institution - 0004
        • Contact:
          • Site 0004
      • New Delhi, India, 110085
        • Local Institution - 0001
        • Contact:
          • Site 0001
    • Maharashtra
      • Navi Mumbai, Maharashtra, India, 400614
        • Local Institution - 0009
        • Contact:
          • Site 0009
      • Pune, Maharashtra, India, 411017
        • Local Institution - 0008
        • Contact:
          • Site 0008
    • Odisha
      • Bhubaneswar, Odisha, India, 751007
        • Local Institution - 0003
        • Contact:
          • Site 0003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for minors (ages 12-17) ONLY.
  • Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) staging system (8th edition).
  • Participants must be treatment-naïve (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma).
  • Participants must have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
  • Participants must have completed prior radiotherapy at least 2 weeks prior to study treatment administration.
  • Individuals of Childbearing Potential (IOCBP) must not be pregnant or breastfeeding.

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.
  • Participants must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment.
  • Participants must not have a history of myocarditis.
  • Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways. Prior treatment with relatlimab or any other with LAG-3 targeted agents.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Administration of Nivolumab + Relatlimab Fixed-Dose Combination (FDC)
Drug: Nivolumab + Relatlimab
Specified dose on specified days
Other Names:
  • BMS-986213
  • Relopduo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events (AEs)
Time Frame: Up to 30 weeks
Up to 30 weeks
Incidence of drug-related AEs
Time Frame: Up to 30 weeks
Up to 30 weeks
Incidence of serious adverse events (SAEs)
Time Frame: Up to 30 weeks
Up to 30 weeks
Incidence of drug-related SAEs
Time Frame: Up to 30 weeks
Up to 30 weeks
Incidence of immune-mediated adverse events (IMAEs)
Time Frame: Up to 30 weeks
Up to 30 weeks
AEs leading to discontinuation of treatment
Time Frame: Up to 30 weeks
Up to 30 weeks
Number of deaths
Time Frame: Up to 30 weeks
Up to 30 weeks
Number of participants with laboratory abnormalities
Time Frame: Up to 30 weeks
Up to 30 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR) as assessed by investigator, using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame: Up to 30 weeks
Up to 30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 15, 2026

Primary Completion (Estimated)

May 26, 2029

Study Completion (Estimated)

May 28, 2029

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA224-1125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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