NCT03400332
Recruiting
January 17, 2018
May 11, 2021
Brief summary:
The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Part 1A: BMS-986253 + nivolumab |
Drug: BMS-986253 Specified dose on specified days Biological: Nivolumab Specified dose on specified days |
Experimental: Part 1B: BMS-986253 + nivolumab |
Drug: BMS-986253 Specified dose on specified days Biological: Nivolumab Specified dose on specified days |
Experimental: Part 1C: BMS-986253 + nivolumab + ipilimumab |
Drug: BMS-986253 Specified dose on specified days Biological: Nivolumab Specified dose on specified days Biological: Ipilimumab Specified dose on specified days |
Experimental: Part 2A: BMS-986253 + nivolumab + ipilimumab |
Drug: BMS-986253 Specified dose on specified days Biological: Nivolumab Specified dose on specified days Biological: Ipilimumab Specified dose on specified days |
Placebo Comparator: Part 2B: Placebo + nivolumab + ipilimumab |
Biological: Nivolumab Specified dose on specified days Biological: Ipilimumab Specified dose on specified days Other: Placebo Specified dose on specified days |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1 At least 1 lesion accessible for biopsy Eastern Cooperative Oncology Group Performance Status of 0 or 1 Exclusion Criteria: Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll) Participants with active, known or suspected autoimmune disease Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS) Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy Other protocol defined inclusion/exclusion criteria could apply
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
United States, Arkansas
Local Institution
Springdale
United States, Colorado
Rocky Mountain Cancer Centers
Denver
United States, Florida
Local Institution
Miami Beach
United States, Maryland
Maryland Oncology Hematology P.A.
Columbia
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Lutherville
United States, Michigan
University Of Michigan Health System
Ann Arbor
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas
United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack
United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick
United States, New York
Icahn School Of Medicine At Mount Sinai
New York
United States, New York
Columbia University Medical Center (Cumc)
New York
United States, Oklahoma
Stephenson Cancer Center
Oklahoma City
United States, Oregon
Willamette Valley Cancer Institute And Research Center
Eugene
United States, Pennsylvania
Local Institution
Philadelphia
United States, Pennsylvania
UPMC Cancer Center
Pittsburgh
United States, South Carolina
Greenville Health System
Greenville
United States, Texas
Texas Oncology-Austin Midtown
Austin
United States, Texas
Texas Oncology - Baylor Charles A. Simmons Cancer Center
Dallas
United States, Texas
Local Institution
Fort Worth
United States, Texas
MD Anderson Cancer Center
Houston
United States, Texas
Texas Oncology-San Antonio Medical Center
San Antonio
United States, Texas
Texas Oncology, P.A.
Tyler
United States, Utah
Local Institution
Salt Lake City
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax
United States, Virginia
Virginia Oncology Associates
Norfolk
Belgium
Local Institution
Bruxelles
Belgium
Local Institution
Gent
Canada, Alberta
Local Institution
Edmonton
Canada, British Columbia
Local Institution
Vancouver
Canada, Ontario
Local Institution
Toronto
Canada, Ontario
Local Institution
Toronto
Canada, Quebec
Local Institution
Montréal
Germany
Local Institution
Berlin
Germany
Local Institution
Gerlingen
Germany
Local Institution
Hamburg
Germany
Local Institution
Hamburg
Germany
Local Institution
Mainz
Germany
Local Institution
Mainz
Germany
Local Institution
Tübingen
Italy
Local Institution
Forlì
Italy
Local Institution
Milano
Italy
Istituto Nazionale Tumori Fondazione Pascale
Napoli
Italy
Local Institution
Rozzano-milano
Spain
Hospital Universitario Ramon Y Cajal
Madrid
Spain
Fundacion Jimenez Diaz
Madrid
Spain
Centro Integral Oncologico Clara Campal
Madrid
Spain
Hospital Universitario Virgen De La Victoria
Malaga
Spain
Clinica Universidad de Navarra
Pamplona
Spain
Hospital Clinico Univ. de Santiago-CHUS
Santiago Compostela
Switzerland
Chu Vaudois Lausanne
Lausanne
Switzerland
Kantonsspital St. Gallen
St.Gallen
Switzerland
University Hospital Zuerich
Zuerich
United Kingdom, Greater Manchester
Local Institution
Manchester
United Kingdom, West Midlands
Local Institution
Birmingham
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb