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Clinical Trials in India / NCT07459543
Starting soon Phase 4

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

NCT07459543 · tracked via the Priya Life Science India tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 4
Started
2026-11-15
Last updated
2026-08-12

Condition(s) studied

Unresectable MelanomaMetastatic Melanoma

Investigational drug(s) / intervention(s)

Nivolumab + Relatlimab

Nivolumab + Relatlimab: Specified dose on specified days

Study summary

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

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
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. Note: Participants with ECOG PS 2 are allowed if the performance status of 2 is attributable to disease burden (and not to significant comorbidity), and if the investigator and Medical Monitor agree the patient may benefit from treatment. * 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 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. Note: Participants may enroll with the following conditions: i) type 1 diabetes mellitus; ii) hypothyroidism only requiring hormone replacement; iii) skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment; iv) conditions not expected to recur in the absence of an external trigger are permitted to enroll. \- 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. Note: Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. * Participants must not have a history of myocarditis. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Local Institution - 0012 Nashik Dādra and Nagar Haveli and Damān and Diu
Local Institution - 0010 Mumbai Maharashtra
Local Institution - 0009 Navi Mumbai Maharashtra
Local Institution - 0008 Pune Maharashtra
Local Institution - 0003 Bhubaneswar Odisha
Local Institution - 0011 Bhubaneswar India
Local Institution - 0002 Chennai India
Local Institution - 0006 Mumbai India
Local Institution - 0005 Nagpur India
Local Institution - 0004 New Delhi India
Local Institution - 0001 New Delhi India

More Bristol-Myers Squibb trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07459543 on ClinicalTrials.gov ↗ ← All trials in India