NEoadjuvant Olaparib Combination OvArian Cancer Targeted Study
Summary
The goal of this phase 2 clinical trial is to learn if the three treatments olaparib, durvalumab and bevacizumab can treat participants with a diagnosis of stage 4 high grade serous ovarian cancer that is too advanced to undergo upfront surgery. The main questions it aims to answer are: Is the treatment able to shrink the cancer sufficiently for participants to undergo surgery? Is the combination of treatments safe in this neoadjuvant (before surgery) setting? This is a single arm study with no comparator arm. Participants will receive the treatment up to 3 cycles with each drug given as follows in a 28-day cycle: Olaparib orally on a twice daily continuous dosing schedule Durvalumab given intravenously on day 1 Bevacizumab given intravenously on day 1 and 15 (Day 15 omitted in C3) Participants will be assessed throughout the study for safety and efficacy endpoints
Timeline
- Start
- 2024-11-01
- Primary completion
- 2026-05-01
- Completion
- 2028-11-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Olaparib | Small molecule | 300 mg | Oral |