About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 history of myocarditis.
Trial design
Single group
Treatments tested in this trial
Nivolumab + Relatlimab
DrugSpecified dose on specified days
Treatment groups
Trial outcomes
Primary outcomes
Incidence of adverse events (AEs)
Incidence of drug-related AEs
Incidence of serious adverse events (SAEs)
Incidence of drug-related SAEs
Secondary outcomes
Objective response rate (ORR) as assessed by investigator, using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Sponsors and contacts
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