RecruitingPhase 2NCT04644289

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

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)


Sponsor

AGO Research GmbH

Enrollment

60 participants

Start Date

May 5, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (WoO — Window of Opportunity) is testing the combination of olaparib (a PARP inhibitor that targets DNA repair) and durvalumab (an immunotherapy drug) in women with advanced ovarian cancer, given during the window between the diagnostic laparoscopy and the main debulking surgery. The goal is to measure early biological effects and see if this combination primes the tumor for better treatment outcomes. **You may be eligible if...** - You are 18 or older - You have presumed advanced-stage ovarian cancer that has not been treated yet and are scheduled for a diagnostic laparoscopy - You are in good general health (ECOG 0–1) - Your life expectancy is at least 16 weeks - You are able to take oral medication - You are postmenopausal or have a confirmed negative pregnancy test **You may NOT be eligible if...** - You have received prior treatment for ovarian cancer - You have active autoimmune disease or take immunosuppressant medications - You are pregnant or breastfeeding - Your organ function is significantly impaired - You are unable or unwilling to provide tissue or blood samples for research Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGolaparib

Olaparib tablets are administrated orally 300 mg twice daily.

DRUGdurvalumab

Durvalumab is administered 1500mg iv as a single dose prior to surgery (corresponding to 1 single cycle) .


Locations(6)

Universitätsklinikum Mannheim GmbH, Frauenklinik

Mannheim, Baden-Wurttemberg, Germany

Klinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Frauenheilkunde

München, Bavaria, Germany

Mammazentrum HH am Krankenhaus Jerusalem, Gynäkologisches Operationszentrum Hamburg

Hamburg, Free and Hanseatic City of Hamburg, Germany

KEM Essen | Evang. Kliniken Essen Mitte

Essen, North Rine-Westphalia, Germany

Universitätsklinikum Carl Gustav Carus Dresden an der technischen Universität Dresden, Gynäkologisches Krebszentrum und Regionales Brustzentrum Dresden am Universitäts-KrebsCentrum

Dresden, Saxony, Germany

Charité Berlin, Klinik für Gynäkologie mit Zentrum für onkologische Chirurgie

Berlin, State of Berlin, Germany

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NCT04644289


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