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

Summary

Participation Requirements

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 ...

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 be offered maintenance treatment with olaparib for 24 months (or according to label).

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