Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05446298 | ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 58 | — | — | Dec 22, 2022 | Aug 30, 2026 | Apr 13, 2026 | 21 | United States |
To assess the efficacy of ONC-392 and pembrolizumab combination therapy in objective response rate per RECIST1.1.
To assess the safety of ONC-392 and pembrolizumab combination therapy
| Arm | Type | Description |
|---|---|---|
| 1 mg/kg ONC-392 and 200 mg pembrolizumab | EXPERIMENTAL | Arm A: Pembrolizumab 200 mg will be administered by IV infusion over 30 minutes, followed by ONC-392 at 1.0 mg/kg will be administered by IV infusion over 60 minutes, q3w. |
| 2 mg/kg ONC-392 and 200 mg pembrolizumab | EXPERIMENTAL | Arm B: Pembrolizumab 200 mg will be administered by IV infusion over 30 minutes, followed by ONC-392 at 2.0 mg/kg will be administered by IV infusion over 60 minutes, q3w. |
| Name | Type | Description |
|---|---|---|
| ONC-392 | DRUG | ONC-392 will be given by IV infusion, q3w. |
| Pembrolizumab | DRUG | Pembrolizumab in fixed dose of 200 mg will be given by IV infusion, q3w. |
Inclusion Criteria: 1. Age ≥ 18 yrs old female patients who provide written informed consent for the study. 2. Patients must have a confirmed diagnosis of high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. 3. Patients must have received prior standard of care of ...