A Phase 1/2a Study of BMS-986205 Administered in Combination With Nivolumab (Anti-PD-1 Monoclonal Antibody) and in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors
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.
18 Years to 100 Years
Accepting Healthy Volunteers?
- 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
- 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
Other protocol defined inclusion/exclusion criteria could apply