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ONC-392 · 1 trial · 4 indications
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 ...
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ONC-392 is an investigational small molecule being studied for the treatment of ovarian cancer, specifically in patients with platinum-resistant disease. It is being evaluated in combination with pembrolizumab for conditions including high grade serous adenocarcinoma of the ovary, primary peritoneal carcinoma, and fallopian tube cancer.
ONC-392 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical research on this investigational oncology drug for ovarian cancer.
ONC-392 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is evaluating its safety and efficacy in patients with platinum-resistant ovarian cancer.
ONC-392 is being studied in a Phase 2 clinical trial with the identifier NCT05446298. This trial, titled 'ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer,' is active but not recruiting and is being conducted in the United States with an enrollment of 58 female participants aged 18 years and older.
Yes, the Phase 2 trial of ONC-392 is randomized and controlled. The trial is not double-blinded, and it uses a controlled design to compare the effects of ONC-392 in combination with pembrolizumab in patients with platinum-resistant ovarian cancer.
Yes, the Phase 2 clinical trial of ONC-392 involves biomarker-selected patient enrollment. This means that the study includes a biomarker-based approach to identify patients who may be more likely to benefit from the treatment being investigated.