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

Sponsor
AGO Research GmbH
Study ID
NCT04644289
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • olaparib — DRUG
    Olaparib tablets are administrated orally 300 mg twice daily.
  • durvalumab — DRUG
    Durvalumab is administered 1500mg iv as a single dose prior to surgery (corresponding to 1 single cycle) .

Study Details

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.

Key Dates

Start date
May 5, 2022
Status verified
Sep 2025
Primary completion
Jan 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: cohort A - olaparib monotherapy
    Olaparib tablets 2 × 300mg per day for 3 weeks (max. 28 days) prior to surgery until one day prior to surgery or withdrawal of informed consent. Patients will receive the indicated standard of care (SoC) chemotherapy plus or minus Bevacizumab as per investigators discretion, followed by SoC maintenance treatment according to the national S3-guideline and treating physician's choice. They can be offered: For patients in cohort A who have received all possible licensed treatment regimens according to the national guideline or for whom further licensed treatment options are not available or contraindicated, Olaparib may be offered as investigational maintenance therapy for up to 24 months.
  • Other: cohort B - olaparib + durvalumab combination
    Olaparib tablets 2 × 300mg per day for 3 weeks (max. 28 days) plus Durvalumab 1500mg iv as a single dose prior to surgery (corresponding to 1 single cycle). Patients will receive the indicated standard of care (SoC) chemotherapy plus or minus Bevacizumab as per investigators discretion, followed by SoC maintenance treatment according to the national S3-guideline and treating physician's choice. They can be offered: Patients in cohort B may be offered Durvalumab 1120mg iv Q3W during chemotherapy treatment phase in combination with bevacizumab (unless contraindicated) and as maintenance for a total of up to 24 months (1120mg Q3W) in combination with Bevacizumab (for a total of 15 months, unless contraindicated) and Olaparib for a total of 24 months. For HRD-positive patients Durvalumab will be an investigational agent; for HRD-negative patients Durvalumab and Olaparib will be investigational agents.

Primary Outcome Measure

Feasibility of the WoO procedure for olaparib alone (cohort a) & olaparib in combination with durvalumab (cohort b) [ Time Frame: 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. ]

Central Contacts

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