NCT03978611
Recruiting
June 7, 2019
April 4, 2022
Brief 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).
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Part 1: Dose Escalation Phase |
Drug: Relatlimab Specified dose on specified days Drug: Ipilimumab Specified dose on specified days |
Experimental: Part 2: Dose Expansion Phase |
Drug: Relatlimab Specified dose on specified days Drug: Ipilimumab Specified dose on specified days |
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
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
United States, Arizona
Arizona Cancer Center
Tucson
United States, California
Hoag Memorial Hospital Presbyterian
Los Angeles
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles
United States, California
John Wayne Cancer Institute
Santa Monica
United States, Colorado
Local Institution
Aurora
United States, Florida
Sylvester Comprehensive Cancer Center
Miami
United States, Florida
Local Institution
Tampa
United States, Illinois
Northwestern University, Feinberg School of Medicine
Chicago
United States, Michigan
University of Michigan
Ann Arbor
United States, New Jersey
Atlantic Health System
Morristown
United States, Texas
Local Institution
San Antonio
United States, Texas
Local Institution
San Antonio
United States, Utah
Local Institution
Salt Lake City
United States, Virginia
Local Institution
Charlottesville
Belgium
Local Institution
Antwerpen
Belgium
Local Institution
Brussels
Belgium
Local Institution
Bruxelles
Belgium
Local Institution
Bruxelles
Canada, Ontario
Local Institution
Ottawa
Canada, Ontario
Local Institution
Toronto
Canada, Quebec
Local Institution
Sherbrooke
Canada
Local Institution
Quebec
France
Local Institution
Bordeaux
France
Local Institution
Lyon
France
Local Institution
Marseille Cedex 5
France
Local Institution
Nantes
France
Local Institution
Paris
Germany
Local Institution
Erlangen
Germany
Local Institution
Essen
Germany
Local Institution
Gera
Germany
Local Institution
Hannover
Germany
Local Institution
Hannover
Germany
Local Institution
Heidelberg
Germany
Local Institution
Lübeck
Germany
Local Institution
Nurnberg
Spain
Local Institution
Barcelona
Spain
Local Institution
Cordoba
Spain
Local Institution
Hospitalet de Llobregat - Barcelona
Spain
Local Institution
Madrid
Spain
Local Institution
San Sebastian
Spain
Local Institution
Valencia
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb