drugset / Trial / NCT03791398
BrUOG 379 Phase Ib/II Trial ONC201 + Nivolumab in MSS mCRC
Phase 1/2
Terminated
13 enrolled
Brown University
Bristol-Myers Squibb · collabOncoceutics, Inc. · collabRhode Island Hospital · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a single arm Phase Ib/II, open label, safety, pharmacokinetic, pharmacodynamics and efficacy study of ONC201 in combination with Opdivo (Nivolumab) in adult patients with metastatic colorectal cancer, for whom no standard therapy is available. This study will enroll adult patients with metastatic colorectal cancer who progressed after at least two lines of therapy.
Timeline
- Start
- 2019-11-15
- Primary completion
- 2021-06-16
- Completion
- 2021-08-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dordaviprone | Small molecule | 375 mg | — |
| Subject | Dordaviprone | Small molecule | 500 mg | — |
| Subject | Dordaviprone | Small molecule | 625 mg | — |
| Background | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |