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Not yet recruiting NCT07459543

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

Phase IV Interventional Untreated Melanoma Unresectable Melanoma Metastatic Melanoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nivolumab + Relatlimab.
Who it may be relevant to
Registry conditions: Untreated Melanoma, Unresectable Melanoma, Metastatic Melanoma. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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 Previously Untreated, Unresectable or Metastatic Melanoma in India.

Overview

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

Interventions

  • Drug Nivolumab + Relatlimab
    Specified dose on specified days

Primary outcome measures

  • 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 outcome measures (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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

India · 8 centers
  • Local Institution - 0009 — Navi Mumbai
  • Local Institution - 0008 — Pune
  • Local Institution - 0003 — Bhubaneswar
  • Local Institution - 0002 — Chennai
  • Local Institution - 0006 — Mumbai
  • Local Institution - 0005 — Nagpur
  • Local Institution - 0004 — New Delhi
  • Local Institution - 0001 — New Delhi

Identifiers

NCT: NCT07459543 · CA224-1125

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗