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

StatusNot Yet Recruiting
PhasePhase 4
Started2026-11-15
View on ClinicalTrials.gov ↗

Amendment history

2026-08-10
Study Identification, Study Status, Study Description, Conditions, Study Design, Eligibility, Contacts/Locations, References v1
Enrollment increased: 30 → 40 participants
Trial sites expanded: 8 → 11 locations
Eligibility criteria+343 characters
Inclusion Criteria - Participants must have an Eastern Cooperative Oncology Group [...] ansky 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 (u [...] nt Committee on Cancer (AJCC) staging system (8th edition). Participants must be treatment-naïve (ie, no prior systemic anticancer therapy for unresectable or m [...] [...]
Study title-11 characters
A Study Toto Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unresectable or Metastatic Melanoma Participants In India
2026-03-05
Original filing
Bristol-Myers Squibb
311 trials monitored
See 15 trials at risk
Melanoma
1,020 trials monitored
See 45 trials at risk
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.
Trial Details
NCT Number NCT07459543
Lead Sponsor Bristol-Myers Squibb
Conditions Unresectable Melanoma, Metastatic Melanoma
Enrollment 40 participants
Start Date 2026-11-15
Primary Completion 2029-05-26 (estimated)
Study Completion 2029-05-28 (estimated)
Updated on ClinicalTrials.gov 2026-08-12