A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)
Part of paid clinical trials in Santa Monica, California.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT03668119
- Phase
- PHASE2
- Status
- Completed
Conditions
- Pan Tumor
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — BIOLOGICALSpecified dose on specified days
- Ipilimumab — BIOLOGICALSpecified dose on specified days
Study Details
The purpose of this study is to demonstrate the clinical activity of nivolumab in combination with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.
Key Dates
- Start date
- Oct 31, 2018
- Status verified
- Jul 2024
- Primary completion
- May 3, 2022
- Completion
- Aug 2, 2023
Study Design
- Enrollment
- 212 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Nivolumab + Ipilimumab Combination
- Experimental: Nivolumab Monotherapy
Primary Outcome Measure
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm A [ Time Frame: From date of randomization up to 42 months ]
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| John Wayne Cancer Center | Santa Monica | California | 90404 | - |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | - |
| Local Institution - 0093 | Minneapolis | Minnesota | 55404 | - |
| Broome Oncology | Johnson City | New York | 13790 | - |
| Duke Cancer Institute | Durham | North Carolina | 27710 | - |
| Local Institution - 0079 | Portland | Oregon | 97239 | - |
| Local Institution - 0095 | Austin | Texas | 78731 | - |
| Local Institution - 0094 | Dallas | Texas | 75231 | - |
| Local Institution - 0090 | Houston | Texas | 77030 | - |
| Texas Oncology - Northeast Texas | Tyler | Texas | 75702 | - |