Melanoma Clinical Trial
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
Summary
The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine the recommended dose of relatlimab in combination with ipilimumab (for dose escalation). It is also to evaluate the safety, tolerability, and preliminary efficacy of the recommended dose of relatlimab in combination with ipilimumab versus ipilimumab monotherapy (for dose expansion).
Eligibility Criteria
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
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There are 25 Locations for this study
Tucson Arizona, 85724, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Santa Monica California, 90404, United States
Miami Florida, 33136, United States
Chicago Illinois, 60611, United States
Ann Arbor Michigan, 48109, United States
Morristown New Jersey, 07960, United States
Bruxelles Brussels, 1000, Belgium
Antwerpen , 2020, Belgium
Brussels , 1090, Belgium
Bruxelles , 1200, Belgium
Ottawa Ontario, K1H 8, Canada
Erlangen , 91054, Germany
Essen , 45147, Germany
Gera , 07548, Germany
Hannover , 30625, Germany
Heidelberg , 69120, Germany
Lübeck , 23562, Germany
Nuremberg , 90419, Germany
Barcelona , 08035, Spain
Cordoba , 14004, Spain
Hospitalet de Llobregat - Barcelona , 08908, Spain
Madrid , 28034, Spain
San Sebastian , 20014, Spain
Valencia , 46009, Spain
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