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

NCT07459543 | Not Yet Recruiting Phase 4

• 1 other identifier: CA224-1125
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Untreated Melanoma; Unresectable Melanoma; Metastatic Melanoma

Keywords

Skin Cancer; Malignant Melanoma; Immunotherapy; India; Nivolumab; Relatlimab

Outcome Measures

Primary Outcomes (8)

• Incidence of adverse events (AEs)

  Up to 30 weeks

• Incidence of drug-related AEs

  Up to 30 weeks

• Incidence of serious adverse events (SAEs)

  Up to 30 weeks

• Incidence of drug-related SAEs

  Up to 30 weeks

• Incidence of immune-mediated adverse events (IMAEs)

  Up to 30 weeks

• AEs leading to discontinuation of treatment

  Up to 30 weeks

• Number of deaths

  Up to 30 weeks

• Number of participants with laboratory abnormalities

  Up to 30 weeks

Secondary Outcomes (1)

• Objective response rate (ORR) as assessed by investigator, using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Up to 30 weeks

Study Arms (1)

Administration of Nivolumab + Relatlimab Fixed-Dose Combination (FDC)

EXPERIMENTAL

Drug: Nivolumab + Relatlimab

Interventions

Nivolumab + Relatlimab DRUG

Specified dose on specified days

Also known as: Relopduo, BMS-986213

Administration of Nivolumab + Relatlimab Fixed-Dose Combination (FDC)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (8)

Local Institution - 0009

Navi Mumbai, Maharashtra, 400614, India

Location

Local Institution - 0008

Pune, Maharashtra, 411017, India

Location

Local Institution - 0003

Bhubaneswar, Odisha, 751007, India

Location

Local Institution - 0002

Chennai, 600006, India

Location

Local Institution - 0006

Mumbai, 400 012, India

Location

Local Institution - 0005

Nagpur, 440001, India

Location

Local Institution - 0004

New Delhi, 110029, India

Location

Local Institution - 0001

New Delhi, 110085, India

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Interventions

Nivolumab; relatlimab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 9, 2026
• Study Start (Estimated): November 15, 2026
• Primary Completion (Estimated): May 26, 2029
• Study Completion (Estimated): May 28, 2029
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

IN (8)