NCT07459543
Not yet recruiting
Phase 4
A Phase 4, Single Arm, Open Label Study to Evaluate Safety, Tolerability, and Efficacy of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in Participants With Previously Untreated, Unresectable or Metastatic Melanoma in India.
InterventionsNivolumab + Relatlimab
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 30
- Locations
- 8
- Primary Endpoint
- Incidence of adverse events (AEs)
Overview
Brief Summary
The purpose of this study is to assess the safety and tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in untreated, unresectable or metastatic melanoma participants in India
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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 be treatment-naïve (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma).
- •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.
- •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.
- •Participants must not have a history of myocarditis.
- •Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways. Prior treatment with relatlimab or any other with LAG-3 targeted agents.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
Arms & Interventions
Administration of Nivolumab + Relatlimab Fixed-Dose Combination (FDC)
Experimental
Intervention: Nivolumab + Relatlimab (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Objective response rate (ORR) as assessed by investigator, using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1(Up to 30 weeks)
Investigators
Study Sites (8)
Loading locations...
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