A Phase 4 interventional study of Nivolumab + Relatlimab in Unresectable Melanoma and Metastatic Melanoma, sponsored by Bristol-Myers Squibb. Not yet recruiting at 11 sites in India. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Bristol-Myers Squibb · Phase 4, Interventional, and Treatment
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's planned enrollment of 40 is close to the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
- 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.
Exclusion Criteria
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.
Drug: Nivolumab + Relatlimab
Specified dose on specified days
Also known as: Relopduo, BMS-986213
Incidence of adverse events (AEs)
Time frame: Up to 30 weeks
Incidence of drug-related AEs
Time frame: Up to 30 weeks
Incidence of serious adverse events (SAEs)
Time frame: Up to 30 weeks
Incidence of drug-related SAEs
Time frame: Up to 30 weeks
Incidence of immune-mediated adverse events (IMAEs)
Time frame: Up to 30 weeks
AEs leading to discontinuation of treatment
Time frame: Up to 30 weeks
Number of deaths
Time frame: Up to 30 weeks
Number of participants with laboratory abnormalities
Time frame: Up to 30 weeks
Objective response rate (ORR) as assessed by investigator, using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 30 weeks
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Sap, Csr
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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