Window-of-opportunity Proof-of-concept, Non-randomized, Open-label Phase II Trial of Olaparib Given Alone (Cohort A) or in Combination With Durvalumab (Cohort B) Prior to Primary Debulking Surgery in Histologically Proven High-grade Epithelial Ovarian Cancer (EOC) (WoO)

NCT04644289 Phase 2 RECRUITING

This is a multi-center, prospective, open-label, phase II trial. Patients with suspected advanced ovarian cancer planned to undergo diagnostic laparoscopy for histologic confirmation and evaluation of disease spread will be registered into the trial after providing a 1st written informed consent.

Details

Lead sponsor	AGO Research GmbH
Phase	Phase 2
Status	RECRUITING
Enrolment	60
Start date	2022-05-05
Completion	2028-06

Conditions

• Epithelial Ovarian Cancer

Interventions

• olaparib
• durvalumab

Primary outcomes

• Feasibility of the WoO procedure for olaparib alone (cohort a) & olaparib in combination with durvalumab (cohort b) — Between registration into the trial until 60 days after surgery or 60 days after the originally planned surgery date in case of switch of therapeutic strategy.
  Defined as the successful completion of the WoO therapy: * Relative dose intensity (RDI) of ≥80% * No treatment-related surgical delays * Adherence to therapeutic strategy * Lack of clinical progression prior to primary debulking surgery * No treatment-related toxicities of any grade that in the judgment of the investigator or surgeon significantly interfered with the subject's optimal perioperative management

Countries

Germany