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
Purpose
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.
Conditions
- Advanced Cancer
- Melanoma
- Non-Small Cell Lung Cancer
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Other protocol defined inclusion/exclusion criteria could apply
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Combination Therapy (Dose Escalation) |
BMS 986205 + Nivolumab specified dose at specified intervals. |
|
|
Experimental Combination Therapy (Dose Expansion) |
BMS 986205 + Nivolumab specified dose at specified intervals. |
|
|
Experimental Combination Therapy 2 (Dose Expansion) |
BMS 986205 + both Nivolumab and ipilimumab specified dose at specified intervals |
|
More Details
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb