NCT04361370

Olaparib Maintenance With Pembrolizumab & Bevacizumab in BRCA Non-mutated Patients With Platinum-sensitive Recurrent Ovarian Cancer

A Single-arm Phase II Study of Olaparib Maintenance With Pembrolizumab & Bevacizumab in BRCA Non-mutated Patients With Platinum-sensitive Recurrent Ovarian Cancer (OPEB-01)

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

'This is a Phase II, open-label, non-randomized, multi-center study assessing the efficacy and safety of Olaparib maintenance with Bevacizumab and Pembrolizumab in subjects with platinum-sensitive who have received prior of platinum-based chemotherapy. The study will assess the effectiveness of progression-free survival(6 months PFS rate) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The subject will be treated to until disease progression as below: * Maintenance : 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)

Conditions

• Platinum-sensitive Recurrent BRCA Wild Type Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Olaparib-Pembrolizumab-Bevacizumab	* 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)

Timeline

• Start date: 2020-10-28
• Primary completion: 2026-05-01
• Completion: 2026-08-01
• First posted: 2020-04-24
• Last updated: 2021-04-19

Locations

1 site across 1 country: South Korea