A Study to Assess Safety of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-Programmed Cell Death Protein 1 (Anti-PD-1) Treatment

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Melanoma

Treatments: Drug: Relatlimab; Drug: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03978611

CA224-083

2019-000132-25 (EudraCT Number)

Details and patient eligibility

About

The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) of relatlimab in combination with ipilimumab.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• 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
• Eastern Cooperative Oncology Group (ECOG) 0-1

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 cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) or lymphocyte-activation gene 3 (LAG-3) targeted agents

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Part 1: Dose Escalation Phase

Experimental group

Treatment:

Drug: Ipilimumab

Drug: Relatlimab