An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread
Trial Status: Closed to Accrual
The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.
Inclusion Criteria
- During dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimen
- During cohort expansion, subjects with advanced cancer that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type
- Subjects must have measurable disease
- Subject must consent to provide previously collected tumor tissue and a tumor biopsy during screening.
- At least 4 weeks since any previous treatment for cancer
- Must be able to swallow pills or capsules
- Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1
Exclusion Criteria
- Active or chronic autoimmune diseases
- Uncontrolled or significant cardiovascular disease
- History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus (HIV), or acquired immune deficiency syndrome (AIDS)
- Chronic hepatitis: Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)
- Active central nervous system (CNS) metastases and CNS metastases as the only sites of disease
- Active infection
Arizona
Tucson
Banner University Medical Center - Tucson
Status: ACTIVE
California
San Diego
UC San Diego Medical Center - Hillcrest
Status: CLOSED_TO_ACCRUAL
Florida
Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Georgia
Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Maryland
Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: COMPLETED
Michigan
Detroit
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL
New Jersey
Hackensack
Hackensack University Medical Center
Status: CLOSED_TO_ACCRUAL
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: COMPLETED
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Pennsylvania
Philadelphia
Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: CLOSED_TO_ACCRUAL
Tennessee
Nashville
Vanderbilt University / Ingram Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Trial Phase Phase I/II
Trial Type Treatment
Lead Organization
Bristol-Myers Squibb
- Primary ID CA017-003
- Secondary IDs NCI-2016-00153, 2015-004914-79
- Clinicaltrials.gov ID NCT02658890