A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O). (DUO-O)

  • End date
    Dec 28, 2027
  • participants needed
  • sponsor
Updated on 24 October 2022


This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.


Eligible patients will be those patients with newly diagnosed, histologically confirmed advanced (Fédération Internationale de Gynécologie et d'Obstétrique [FIGO] Stage III-IV) ovarian, primary peritoneal cancer and/or fallopian-tube cancer. All patients should be candidates for cytoreductive surgery which could be conducted as immediate upfront primary surgery following diagnosis or can be conducted after initiation of platinum based neoadjuvant chemotherapy. All patients should be eligible to start first line platinum based chemotherapy in combination with bevacizumab.

The study aims to evaluate the efficacy and safety of standard of care (SoC) platinum-based chemotherapy and bevacizumab followed by maintenance bevacizumab either as monotherapy, or in combination with durvalumab, or in combination with durvalumab and olaparib. Therefore, this study aims to see which combination allows patients to live longer without the cancer coming back or getting worse. The study is also looking to see which combination makes patients live longer and how the treatment and the cancer affects their quality of life.

Condition Advanced Ovarian Cancer
Treatment bevacizumab, durvalumab, olaparib, Placebo olaparib, Durvalumab placebo, Carboplatin+Paclitaxel
Clinical Study IdentifierNCT03737643
Last Modified on24 October 2022


Yes No Not Sure

Inclusion Criteria

Female patients with newly diagnosed, histologically confirmed, advanced (Stage III-IV)
high grade epithelial ovarian cancer including high grade serious, high grade endometriod
clear cell ovarian cancer or carcinosarcoma, primary peritoneal cancer and / or
fallopian-tube cancer
Patients must be aged ≥18 years of age. For patients enrolled in Japan that are aged
<20 year
Evidence of presence or absence of BRCA1/2 mutation in tumour tissue
All patients should be candidates for cytoreductive surgery either: upfront primary
Mandatory provision of tumour sample for centralised tBRCA testing
surgery OR plan to undergo chemotherapy with interval debulking surgery
ECOG performance status 0-1
Patients must have preserved organ and bone marrow function
Postmenopausal or evidence of non-childbearing status for women of childbearing
potential: negative urine or serum pregnancy test

Exclusion Criteria

Prior systemic anti-cancer therapy for ovarian cancer
Non-epithelial ovarian cancer, borderline tumors, low grade epithelial tumors or mucinous
Prior treatment with PARP inhibitor or immune mediated therapy
Planned intraperitoneal cytotoxic chemotherapy
Inability to determine the presence or absence of a deleterious or suspected
Active or prior documented autoimmune or inflammatory disorders
deleterious BRCA mutation
Clinically significant cardiovascular disease
Patients with known brain metastases
History of another primary malignancy except for
Patients considered a poor medical risk due to a serious, uncontrolled intercurrent
Adequately treated carcinoma in situ without evidence of disease
Endometrial cancer FIGO Stage IA, Grade 1 or Grade 2
Persistent toxicities CTCAE Grade >2 caused by previous cancer therapy
Malignancy treated with curative intent and with no known active disease ≥5 years
Breast feeding women
before the first dose of study treatment and of low potential risk for recurrence
(patients who have received prior adjuvant chemotherapy for early stage breast
cancer may be eligible, provided that it was completed ≥3 years prior to
registration, and that the patient remains free of recurrent or metastatic
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
of disease
Patients with a known hypersensitivity to olaparib, durvalumab or any of the
excipients of these products and to the combination/comparator agents
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