Nivolumab and relatlimab together for advanced melanoma that cannot be removed by surgery
Tests nivolumab plus relatlimab for safety in people with advanced melanoma.
Plain-language title generated from the registry record
Registry title: A Study to Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Unresectable or Metastatic Melanoma Participants In India
Key facts
- Where
- Bhubaneswar, Chennai, Mumbai, Nagpur, Nashik, Navi Mumbai, New Delhi, and Pune, IndiaSee the 11 sites
- Phase
- Phase 4
Where in India
- BhubaneswarBhubaneswar, IndiaNo longer taking part
- BhubaneswarBhubaneswar, IndiaNo longer taking part
- ChennaiChennai, IndiaNo longer taking part
- MumbaiMumbai, IndiaNo longer taking part
- MumbaiMumbai, IndiaNo longer taking part
- NagpurNagpur, IndiaNo longer taking part
- NashikNashik, IndiaNo longer taking part
- Navi MumbaiNavi Mumbai, IndiaNo longer taking part
- New DelhiNew Delhi, IndiaNo longer taking part
- New DelhiNew Delhi, IndiaNo longer taking part
- PunePune, IndiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07459543
- Record updated
- 12 August 2026
- Original description
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.Read full original descriptionShow less
A Phase 4, Single Arm, Open Label Study to Evaluate Safety, Tolerability, and Efficacy of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in Participants With 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 unresectable or metastatic melanoma participants in India.
Inclusion: 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: 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 an active, known, or suspected autoimmune disease; Note: Participants may enroll with the following conditions:; 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 history of myocarditis; Participants must not have active brain metastases or leptomeningeal metastases; Participants must not have uveal melanoma; Other protocol-defined Inclusion/Exclusion criteria apply.