A Study to Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Unresectable or Metastatic Melanoma Participants In India

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12+
SponsorBristol-Myers Squibb

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

Qualifiers

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

Treatments tested in this trial

  • Nivolumab + Relatlimab

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators