Recruiting
A Study to Assess Safety and Efficacy of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-PD-1 Treatment - CA224-083
Updated: 23 August, 2021 | ClinicalTrials.gov
Print Friendly Summary
Trial Details
Phase
Gender(s)
Age Range
Location(s)
Recruiting
Treatment Options
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 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.
We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information
