A Study to Assess Safety and Efficacy of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-PD-1 Treatment

Phase 1

• Conditions: Melanoma; MedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-000132-25-FR
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-03
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 403

Inclusion Criteria

•Must have documented progression while on a prior anti-programmed cell death protein 1 (PD-1) containing regimen limited to Nivolumab or Pembrolizumab.
•Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test
•Participants must have histologically confirmed advanced unresectable (Stage III) or metastatic (Stage IV) melanoma, as per AJCC staging system
•Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses.
•BRAF wild type and mutant participants are eligible
•Eastern Cooperative Oncology Group (ECOG) 0-1
•Ability to comply with treatment, patient-reported outcomes (PROs), PK, and pharmacodynamic sample collection and required study follow-up

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 181
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 222

Exclusion Criteria

•History of uveal melanoma
•Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
•Prior treatment with ipilimumab, relatlimab, or any other CTLA-4 or LAG-3 targeted agents
•Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1 and HIV-2 antibody.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified