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NCT Number: NCT07459543

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

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Local Institution - 0009, Navi Mumbai, Maharashtra, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nivolumab + Relatlimab

Drug

Specified dose on specified days

Other names: Relopduo, BMS-986213

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to 30 weeks

  2. Incidence of drug-related AEs

    Time frame: Up to 30 weeks

  3. Incidence of serious adverse events (SAEs)

    Time frame: Up to 30 weeks

  4. Incidence of drug-related SAEs

    Time frame: Up to 30 weeks

  5. Incidence of immune-mediated adverse events (IMAEs)

    Time frame: Up to 30 weeks

  6. AEs leading to discontinuation of treatment

    Time frame: Up to 30 weeks

  7. Number of deaths

    Time frame: Up to 30 weeks

  8. Number of participants with laboratory abnormalities

    Time frame: 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

    Time frame: Up to 30 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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