A Study to Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (… (NCT07459543) | Clinical Trial Compass
Not Yet RecruitingPhase 4
A Study to Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Unresectable or Metastatic Melanoma Participants In India
India40 participantsStarted 2026-11-15
Plain-language 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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events (AEs)
Timeframe: Up to 30 weeks
2
Incidence of drug-related AEs
Timeframe: Up to 30 weeks
3
Incidence of serious adverse events (SAEs)
Timeframe: Up to 30 weeks
4
Incidence of drug-related SAEs
Timeframe: Up to 30 weeks
5
Incidence of immune-mediated adverse events (IMAEs)
Timeframe: Up to 30 weeks
6
AEs leading to discontinuation of treatment
Timeframe: Up to 30 weeks
7
Number of deaths
Timeframe: Up to 30 weeks
8
Number of participants with laboratory abnormalities
Trial details
NCT IDNCT07459543
SponsorBristol-Myers Squibb
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2029-05-26
Contact for this trial
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com