Trials / Completed
CompletedNCT03668119
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)
A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination With Ipilimumab or Nivolumab Monotherapy in Participants With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 212 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Nivolumab | Specified dose on specified days |
| BIOLOGICAL | Ipilimumab | Specified dose on specified days |
Timeline
- Start date
- 2018-10-31
- Primary completion
- 2022-05-03
- Completion
- 2023-08-02
- First posted
- 2018-09-12
- Last updated
- 2024-08-28
- Results posted
- 2023-05-18
Locations
60 sites across 17 countries: United States, Argentina, Australia, Belgium, Canada, Chile, Denmark, France, Germany, Italy, Netherlands, Poland, Puerto Rico, Romania, Singapore, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03668119. Inclusion in this directory is not an endorsement.