Trials / Active Not Recruiting
Active Not RecruitingNCT05446298
ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer
Phase 2 Randomized Open-label Multicenter Study of Combination of ONC-392 and Pembrolizumab for the Treatment of Patients With Platinum Resistant Ovarian Cancer (PROC)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- OncoC4, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a study to test the safety and efficacy with the combination of a next generation anti-CTLA-4 antibody, ONC-392, and anti-PD-1 antibody, pembrolizumab, in platinum resistant ovarian cancer patients.
Detailed description
The purpose of this Phase 2 study is to compare two doses of ONC-392 in combination with a fixed dose of pembrolizumab in participants with ovarian cancer who are resistant to platinum-based chemotherapy and have disease progression on line of therapy containing bevacizumab. Results from this study will be used to inform the study design, patient population, and dose selection for future studies in advanced ovarian cancer.
Conditions
- Ovarian Cancer
- High Grade Serous Adenocarcinoma of Ovary
- Primary Peritoneal Carcinoma
- Fallopian Tube Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ONC-392 | ONC-392 will be given by IV infusion, q3w. |
| DRUG | Pembrolizumab | Pembrolizumab in fixed dose of 200 mg will be given by IV infusion, q3w. |
Timeline
- Start date
- 2022-12-22
- Primary completion
- 2026-08-30
- Completion
- 2026-08-30
- First posted
- 2022-07-06
- Last updated
- 2026-04-13
Locations
21 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05446298. Inclusion in this directory is not an endorsement.