An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT02598960
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- BMS-986156 — DRUG
- Nivolumab — DRUG
Study Details
The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or cancers that have spread.
Key Dates
- Start date
- Oct 14, 2015
- Status verified
- Feb 2023
- Primary completion
- Dec 16, 2019
- Completion
- Dec 16, 2019
Study Design
- Enrollment
- 295 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: BMS-986156: Dose Escalation
- Experimental: BMS-986156 + nivolumab (nivo): Dose Escalation
- Experimental: BMS-986156: Dose Expansion
- Experimental: BMS-986156 + nivolumab (nivo): Dose Expansion
- Experimental: BMS986156 + Nivo: Cohort Expansion
Primary Outcome Measure
Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths [ Time Frame: From first treatment to 100 days post last dose. Approximately 29 months ]
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University Of Alabama At Birmingham | Birmingham | Alabama | 35294-3300 | - |
| UCSD Moores Cancer Center | La Jolla | California | 92093-0698 | - |
| Emory University | Atlanta | Georgia | 30322 | - |
| The Ohio State University | Columbus | Ohio | 43210 | - |
| Providence Portland Medical Center | Portland | Oregon | 97213 | - |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | - |
| The West Clinic, P.C. | Germantown | Tennessee | 38138 | - |
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