Unresectable MelanomaPhase 4NCT07459543
A Study to Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Unresectable or Metastatic Melanoma Participants In India
A Phase 4 study testing Nivolumab + Relatlimab in people with Unresectable Melanoma and Metastatic Melanoma, run by Bristol-Myers Squibb at 11 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Unresectable Melanoma, Metastatic Melanoma
- What is being tested?
- Nivolumab + Relatlimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 11 sitesIndia
- Study dates
- 15 Nov 2026to 28 May 2029
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- 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.
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- 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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
11 sites in 1 country
India11 sites
Local Institution - 0003
Bhubaneswar, Odisha, 751007
Site 0003
Local Institution - 0011
Bhubaneswar, 751019
Site 0011
Local Institution - 0002
Chennai, 600006
Site 0002
Local Institution - 0010
Mumbai, Maharashtra, 400052
Site 0010
Local Institution - 0006
Mumbai, 400 012
Site 0006
Local Institution - 0005
Nagpur, 440001
Site 0005
Local Institution - 0012
Nashik, Dādra and Nagar Haveli and Damān and Diu, 422001
Site 0012
Local Institution - 0009
Navi Mumbai, Maharashtra, 400614
Site 0009
Local Institution - 0004
New Delhi, 110029
Site 0004
Local Institution - 0001
New Delhi, 110085
Site 0001
Local Institution - 0008
Pune, Maharashtra, 411017
Site 0008
About this study
Official title: 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.
- Conditions
- Unresectable Melanoma, Metastatic Melanoma
- Being tested
- Nivolumab + Relatlimab
- Keywords
- Skin Cancer, Malignant Melanoma, Immunotherapy, India, Nivolumab, Relatlimab
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab + RelatlimabDrug
Also called Relopduo, BMS-986213
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Administration of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) | Experimental | Not described Receives: Drug: Nivolumab + Relatlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Measured: Up to 30 weeks
Incidence of drug-related AEs
Measured: Up to 30 weeks
Incidence of serious adverse events (SAEs)
Measured: Up to 30 weeks
Incidence of drug-related SAEs
Measured: Up to 30 weeks
Incidence of immune-mediated adverse events (IMAEs)
Measured: Up to 30 weeks
AEs leading to discontinuation of treatment
Measured: Up to 30 weeks
Number of deaths
Measured: Up to 30 weeks
Number of participants with laboratory abnormalities
Measured: Up to 30 weeks
Secondary outcomes (1)
Objective response rate (ORR) as assessed by investigator, using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: Up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start15 Nov 2026 (estimated)
- Primary completion26 May 2029 (estimated)
- Study completion28 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable MelanomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459543
- Sponsor's protocol ID
- CA224-1125
- Status last verified
- Jul 2026
- First submitted
- 5 Mar 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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