Spots Global Cancer Trial Database for WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC

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Trial Identification

Brief Title: WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC

Official Title: 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)

Study ID: NCT04644289

Conditions

Epithelial Ovarian Cancer

Interventions

olaparib

durvalumab

Study Description

Brief Summary: 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.

Detailed Description: In total, 60 patients are planned to be enrolled in 2 consecutive cohorts (30 patients per cohort) into the trial. After histologic confirmation of high-grade epithelial non-mucinous, non-clear cell ovarian cancer, patients will be treated in two consecutive cohorts (A, B) of 30 patients each, with A) olaparib alone or B) olaparib in combination with durvalumab Treatment allocation will take place in two consecutive cohorts rather than by randomization. This will allow to evaluate the safety and feasibility in a stepwise approach. A trial steering committee (TSC) meeting will take place between the cohorts to review safety and feasibility prior to starting the second cohort. The safety follow-up of the first cohort will take 90 days as of the first dose of therapy. The window-of-opportunity treatment phase will be followed by primary debulking surgery and standard of care platinum based first-line chemotherapy at the discretion of the investigator. After completion of first-line chemotherapy patients who have not progressed during first-line chemotherapy will receive the indicated standard maintenance treatment according to the national S3-guideline and treating physician's choice. For patients who have received all possible licensed treatment regimens according to the national guideline or for whom further licensed treatment options are contraindicated, Olaparib may be offered as investigational maintenance therapy for up to 24 months.