NCT03369223
Recruiting
December 11, 2017
May 3, 2022
Brief summary:
The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Part 1A: BMS-986249 |
Biological: BMS-986249 Specified dose on specified days |
Experimental: Part 1B: BMS-986249 + nivolumab (nivo) |
Biological: BMS-986249 Specified dose on specified days Biological: Nivolumab Specified dose on specified days |
Experimental: Part 2A Arm A: BMS-986249 + nivo then nivo Previously untreated unresectable stage III-IV melanoma Enrollment is closed for this Arm |
Biological: BMS-986249 Specified dose on specified days Biological: Nivolumab Specified dose on specified days |
Experimental: Part 2A Arm B: BMS-986249 + nivo Previously untreated unresectable stage III-IV melanoma Enrollment is closed for this Arm |
Biological: BMS-986249 Specified dose on specified days Biological: Nivolumab Specified dose on specified days |
Experimental: Part 2A Arm C: BMS-986249 + nivo Previously untreated unresectable stage III-IV melanoma |
Biological: BMS-986249 Specified dose on specified days Biological: Nivolumab Specified dose on specified days |
Experimental: Part 2A Arm F: BMS-986249 + nivo Previously untreated unresectable stage III-IV melanoma |
Biological: BMS-986249 Specified dose on specified days Biological: Nivolumab Specified dose on specified days |
Experimental: Part 2B Cohort 1: BMS-986249 + nivo Advanced or intermediate hepatocellular carcinoma (HCC) |
Biological: BMS-986249 Specified dose on specified days Biological: Nivolumab Specified dose on specified days |
Experimental: Part 2B Cohort 2: BMS-986249 + nivo Metastatic castration-resistant prostate cancer (CRPC) |
Biological: BMS-986249 Specified dose on specified days Biological: Nivolumab Specified dose on specified days |
Experimental: Part 2B Cohort 3: BMS-986249 + nivo Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) |
Biological: BMS-986249 Specified dose on specified days Biological: Nivolumab Specified dose on specified days |
Experimental: Part 2A Arm D: ipilimumab + nivo then nivo Previously untreated unresectable stage III-IV melanoma |
Biological: Nivolumab Specified dose on specified days Biological: Ipilimumab Specified dose on specified days |
Experimental: Part 2A Arm E: Nivo Previously untreated unresectable stage III-IV melanoma Enrollment is closed for this Arm |
Biological: Nivolumab Specified dose on specified days |
Inclusion Criteria: Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease or metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on CT/MRI for prostate cancer and have at least 1 lesion accessible for biopsy. For Part 2B participants with HCC, intermediate disease is allowed. Eastern Cooperative Oncology Group Performance Status of 0 or 1 Must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to tumor type, if such a therapy exists Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants Willing and able to comply with all study procedures Exclusion Criteria: Primary central nervous system (CNS) malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded Other active malignancy requiring concurrent intervention Prior organ allograft Active, known, or suspected autoimmune disease Other protocol-defined inclusion/exclusion criteria apply
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, Colorado
University of Colorado - Cancer Center - PPDS
Aurora
United States, Colorado
Rocky Mountain Cancer Centers
Denver
United States, Florida
Baptist Health Medical Group Oncology LLC
Miami
United States, Maryland
Johns Hopkins University
Baltimore
United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack
United States, New York
Columbia University Medical Center (Cumc)
New York
United States, New York
Memorial Sloan Kettering Nassau
New York
United States, Ohio
University of Cincinnati Medical Center
Cincinnati
United States, Oregon
Willamette Valley Cancer Institute And Research Center
Eugene
United States, Pennsylvania
University of Pennsylvania
Philadelphia
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
MD Anderson Cancer Center
Houston
United States, Texas
Texas Oncology-San Antonio Medical Center
San Antonio
United States, Texas
Texas Oncology - DFWW
Tyler
United States, Virginia
Virginia Cancer Specialists (Leesburg) - USOR
Leesburg
United States, Virginia
Virginia Oncology Associates
Norfolk
United States, Washington
Northwest Cancer Specialists
Vancouver
Argentina, Distrito Federal
Local Institution - 0038
Buenos Aires
Argentina, Distrito Federal
Local Institution - 0052
Caba
Argentina
Local Institution - 0037
Buenos Aires
Australia, New South Wales
Local Institution - 0015
North Sydney
Australia, South Australia
Local Institution
Adelaide
Australia, Victoria
Local Institution
Frankston
Australia, Victoria
Austin Hospital
Heidelberg
Canada, Alberta
Local Institution
Edmonton
Canada
Local Institution - 0056
Ottawa
Chile, Metropolitana
Local Institution - 0036
Santiago
Finland
Local Institution - 0039
Helsinki
Germany
Local Institution
Essen
Germany
Local Institution
Hamburg
Germany
Local Institution
Heidelberg
Germany
Local Institution
Koeln
Italy
Local Institution
Milano
Italy
Local Institution - 0020
Napoli
Italy
Local Institution - 0049
Siena
Poland, Mazowieckie
Local Institution
Warszawa
Romania
Local Institution - 0045
Bucharest
Romania
Local Institution - 0041
Craiova
Spain, Madrid, Comunidad De
Local Institution - 0022
Madrid
Spain
Hospital Universitari Germans Trias I Pujol
Badalona-barcelona
Spain
H. Univ. Vall dHebron
Barcelona
Spain
Local Institution - 0023
Madrid
Spain
Local Institution - 0050
Madrid
Spain
Hospital Universitario Virgen De La Victoria
Malaga
Switzerland
Local Institution
Lausanne
Switzerland
Local Institution
Zuerich
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb