An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT02754141
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- Malignant Solid Tumor
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- BMS-986179 — BIOLOGICALSpecified dose on specified days
- Nivolumab — BIOLOGICALSpecified dose on specified days
- rHuPH20 — BIOLOGICALSpecified dose on specified days
Study Details
The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.
Key Dates
- Start date
- Jun 21, 2016
- Status verified
- Mar 2023
- Primary completion
- Oct 12, 2021
- Completion
- Oct 12, 2021
Study Design
- Enrollment
- 235 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A-MonotherapyBMS-986179, dose as specified
- Experimental: Arm B- Combination TherapyBMS-986179 + nivolumab, dose as specified
- Experimental: Arm C-Combination TherapyBMS-986179 + rHuPH20, dose as specified
Primary Outcome Measure
Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths. [ Time Frame: From first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. ]
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0028 | Chicago | Illinois | 60611 | - |
| Local Institution - 0001 | Baltimore | Maryland | 21287 | - |
| Local Institution - 0022 | Boston | Massachusetts | 02215 | - |
| Local Institution - 0023 | Buffalo | New York | 14263 | - |
| Local Institution - 0005 | New York | New York | 10032 | - |
| Local Institution - 0020 | Pittsburgh | Pennsylvania | 15232 | - |
| Local Institution - 0004 | Nashville | Tennessee | 37203 | - |
| Local Institution - 0009 | Dallas | Texas | 75230 | - |
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