Actively Recruiting
WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC
Led by AGO Research GmbH · Updated on 2025-10-03
60
Participants Needed
6
Research Sites
317 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with presumed and untreated advanced ovarian cancer planned for laparoscopy for diagnosis and treatment planning
- Able and willing to follow study protocol, including treatments, visits, and follow-up
- Willing to provide fresh frozen biopsy samples from laparoscopy and surgery, plus serial liquid biopsies
- Willing to provide formalin-fixed paraffin embedded tissue samples from laparoscopy and surgery
- Age 18 years or older
- Able to give signed informed consent
- Signed consent for mandatory biomarker, genetic research, clinical, and therapeutic parts of the study
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy of at least 16 weeks
- Ability to take oral medication
- Postmenopausal or confirmed non-childbearing status for women of childbearing potential with negative pregnancy tests
- Women of childbearing potential and partners must use two effective contraception methods or abstain from sexual intercourse during and for 6 months after treatment
- Confirmed advanced (FIGO IIB/III/IV) high-grade, non-mucinous, non-clear cell epithelial ovarian, fallopian tube, or primary peritoneal cancer or known BRCA mutation
- Planned primary debulking surgery after diagnosis and evaluation
- Body weight greater than 30 kg
- Normal organ and bone marrow function within 28 days before treatment as defined by specific hemoglobin, neutrophil, platelet, bilirubin, liver enzymes, and creatinine clearance levels
- Successful contribution of blood and tissue samples as required
You will not qualify if you...
- Disease needing urgent surgery
- Significant uncontrolled diseases affecting study compliance
- Severe uncontrolled symptoms like large ascites, breathlessness, pain needing opioids, or bowel obstruction signs
- Uncontrolled illnesses including infections, heart failure, recent heart attack, unstable angina, arrhythmia, lung disease, seizures, spinal cord compression, or psychiatric/social issues affecting consent or safety
- Other cancers unless treated and disease-free for 5 years, with few exceptions
- Uncontrolled cardiac conditions or congenital long QT syndrome
- Ongoing toxicities from previous cancer treatments except certain exceptions
- Myelodysplastic syndrome or acute myeloid leukemia
- Brain metastases or spinal cord compression without stable disease
- Poor medical risk from serious uncontrolled illnesses or infections
- Inability to swallow oral medication or gastrointestinal issues affecting absorption
- Immunocompromised status including HIV infection
- Active infections including tuberculosis, hepatitis B or C under certain conditions
- ECOG performance status 2 or higher
- Allergies to study drugs or excipients
- Prior cancer therapy for ovarian or related cancers
- Recent chemotherapy or radiotherapy within 3 weeks except for palliative care
- Concurrent cancer treatments except non-cancer hormonal therapy
- Planned neoadjuvant chemotherapy or unresectable disease
- Use of certain CYP3A inhibitors or inducers without required washout periods
- Recent major surgery within 2 weeks before treatment start
- History of organ or bone marrow transplantation
- Prior treatment with olaparib or other PARP inhibitors
- Recent blood transfusions except certain types
- Pregnancy, breastfeeding, or unwillingness to use birth control
- Participation in other interventional trials within 3 months
- Unsuitability for study participation or compliance
- Additional criteria for cohort B including recent anticancer therapy, unresolved toxicities, autoimmune disorders, infections, immunosuppressive medication use, vaccination restrictions, and prior immunotherapy history
- Signs of bowel obstruction or malignant bowel issues
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Universitätsklinikum Mannheim GmbH, Frauenklinik
Mannheim, Baden-Wurttemberg, Germany, 68167
Actively Recruiting
2
Klinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Frauenheilkunde
München, Bavaria, Germany, 81675
Actively Recruiting
3
Mammazentrum HH am Krankenhaus Jerusalem, Gynäkologisches Operationszentrum Hamburg
Hamburg, Free and Hanseatic City of Hamburg, Germany, 20357
Actively Recruiting
4
KEM Essen | Evang. Kliniken Essen Mitte
Essen, North Rine-Westphalia, Germany, 45136
Actively Recruiting
5
Universitätsklinikum Carl Gustav Carus Dresden an der technischen Universität Dresden, Gynäkologisches Krebszentrum und Regionales Brustzentrum Dresden am Universitäts-KrebsCentrum
Dresden, Saxony, Germany, 01307
Actively Recruiting
6
Charité Berlin, Klinik für Gynäkologie mit Zentrum für onkologische Chirurgie
Berlin, State of Berlin, Germany, 13353
Actively Recruiting
Research Team
Y
Yvonne Treffner, Dr.
CONTACT
J
Jana Warby
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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