Trials / Terminated
TerminatedNCT03791398
BrUOG 379 Phase Ib/II Trial ONC201 + Nivolumab in MSS mCRC
BrUOG 379: A Phase Ib/II Single Arm Study of ONC201 Plus Nivolumab in Microsatellite Stable (MSS) Metastatic Colorectal Cancer (mCRC) Patients
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Brown University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dose level 1 ONC201 625mg | ONC201 625mg + Nivolumab 240mg IV flat dose |
| DRUG | Dose level 2 ONC201 500mg | ONC201 500mg + Nivolumab 240mg IV flat dose |
| DRUG | Dose level 3 ONC201 375mg | ONC201 375mg + Nivolumab 240mg IV flat dose |
Timeline
- Start date
- 2019-11-15
- Primary completion
- 2021-06-16
- Completion
- 2021-08-05
- First posted
- 2019-01-02
- Last updated
- 2023-02-17
- Results posted
- 2022-06-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03791398. Inclusion in this directory is not an endorsement.