Olaparib Maintenance With Pembrolizumab & Bevacizumab in BRCA Non-mutated Patients With Platinum-sensitive Recurrent Ovarian Cancer
- Sponsor
- Yonsei University
- Study ID
- NCT04361370
- Phase
- PHASE2
- Status
- Enrolling By Invitation
Conditions
- Platinum-sensitive Recurrent BRCA Wild Type Ovarian Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 20 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Olaparib-Pembrolizumab-Bevacizumab — DRUG* Olaparib 300mg (twice daily \[BID\]) * Pembrolizumab 200mg every 3 weeks (Q3W) from 2nd infusion for up to 35 infusions * Bevacizumab 15mg/kg or 7.5mg/kg every 3 weeks (Q3W)
Study Details
This study is phase II, open label, clinical trial to determine the efficacy of Olaparib maintenance with Bevacizumab and Pembrolizumab by assessment progression-free survival(6 months PFS rate) in BRCA non-mutated patients with platinum-sensitive recurrent ovarian cancer.
Key Dates
- Start date
- Oct 28, 2020
- Status verified
- Apr 2021
- Primary completion
- May 31, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 44 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment groupBRCA mutation wild type, non-mucinous , platinum-sensitive recurrent ovarian cancer
Primary Outcome Measure
progression-free survival(6 months PFS rate) [ Time Frame: 6 months ]