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Brief Title: An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors
Official Title: A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
Study ID: NCT01968109
Brief Summary: The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery. The following tumor types are included in this study: Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.
Detailed Description:
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Local Institution - 0043, La Jolla, California, United States
Local Institution - 0053, Aurora, Colorado, United States
Local Institution - 0058, Tampa, Florida, United States
Local Institution - 0003, Chicago, Illinois, United States
Local Institution - 0048, Niles, Illinois, United States
Local Institution - 0004, Baltimore, Maryland, United States
Local Institution - 0001, Boston, Massachusetts, United States
Local Institution - 0011, Detroit, Michigan, United States
Local Institution - 0051, Rochester, Minnesota, United States
Local Institution - 0044, Saint Louis, Missouri, United States
Local Institution - 0005, New York, New York, United States
Local Institution - 0002, Portland, Oregon, United States
Local Institution - 0047, Allentown, Pennsylvania, United States
Local Institution - 0010, Pittsburgh, Pennsylvania, United States
Local Institution - 0057, Dallas, Texas, United States
Local Institution - 0045, Houston, Texas, United States
Local Institution - 0008, Seattle, Washington, United States
Local Institution - 0029, North Sydney, New South Wales, Australia
Local Institution - 0031, Brisbane, Queensland, Australia
Local Institution - 0039, Southport, Queensland, Australia
Local Institution - 0033, Melbourne, Victoria, Australia
Local Institution - 0032, Nedlands, Western Australia, Australia
Local Institution - 0023, Wien, , Austria
Local Institution - 0024, Wien, , Austria
Local Institution - 0049, Toronto, Ontario, Canada
Local Institution - 0050, Quebec City, Quebec, Canada
Local Institution - 0028, Copenhagen, , Denmark
Local Institution - 0020, Herlev, , Denmark
Local Institution - 0021, Helsinki, Uusimaa, Finland
Local Institution - 0038, Marseille Cedex 5, , France
Local Institution - 0037, Nantes Cedex 01, , France
Local Institution - 0036, Pierre Benite Cedex, , France
Local Institution - 0026, Toulouse Cedex 9, , France
Local Institution - 0018, Villejuif, , France
Local Institution - 0007, Essen, , Germany
Local Institution - 0040, Heilbronn, , Germany
Local Institution - 0041, Wuerzburg, , Germany
Local Institution - 0014, Milano, , Italy
Local Institution - 0013, Napoli, , Italy
Local Institution - 0035, Padova, , Italy
Local Institution - 0055, Nagoya-shi, Aichi, Japan
Local Institution - 0059, Sapporo-shi, Hokkaido, Japan
Local Institution - 0054, Sunto-gun, Shizuoka, Japan
Local Institution - 0052, Chuo-ku, Tokyo, Japan
Local Institution - 0025, Amsterdam, , Netherlands
Local Institution - 0019, Oslo, , Norway
Local Institution - 0015, Barcelona, , Spain
Local Institution - 0046, Malaga, , Spain
Local Institution - 0006, Pamplona, , Spain
Local Institution - 0017, Lausanne, , Switzerland
Local Institution - 0016, Zuerich, , Switzerland
Local Institution - 0027, London, Greater London, United Kingdom
Local Institution - 0022, London, Greater London, United Kingdom
Local Institution - 0034, Manchester, , United Kingdom
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR