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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Nivolumab + Relatlimab

    Drug

    Specified dose on specified days

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Administration of Nivolumab + Relatlimab Fixed-Dose Combination (FDC)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs)

Time frame
Up to 30 weeks
2

Incidence of drug-related AEs

Time frame
Up to 30 weeks
3

Incidence of serious adverse events (SAEs)

Time frame
Up to 30 weeks
4

Incidence of drug-related SAEs

Time frame
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

Time frame
Up to 30 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: