Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients.



Status:Recruiting
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 127
Updated:4/6/2019
Start Date:January 4, 2019
End Date:July 28, 2025
Contact:AstraZeneca Clinical Study Information Center
Email:information.center@astrazeneca.com
Phone:1-877-240-9479

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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).

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.

Key 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

- All patients should be candidates for cytoreductive surgery either: upfront primary
surgery OR plan to undergo chemotherapy with interval debulking surgery

- Evidence of presence or absence of BRCA1/2 mutation in tumour tissue

- Mandatory provision of tumour sample for centralised tBRCA testing

- 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

Key Exclusion Criteria:

Non-epithelial ovarian cancer, borderline tumors, low grade epithelial tumors or mucinous
histology

- Prior systemic anti-cancer therapy for ovarian cancer

- Inability to determine the presence or absence of a deleterious or suspected
deleterious BRCA mutation

- Prior treatment with PARP inhibitor or immune mediated therapy

- Planned intraperitoneal cytotoxic chemotherapy

- Active or prior documented autoimmune or inflammatory disorders

- Patients considered a poor medical risk due to a serious, uncontrolled intercurrent
illness

- Clinically significant cardiovascular disease

- Patients with known brain metastases

- History of another primary malignancy except for:

- Malignancy treated with curative intent and with no known active disease ≥5 years
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
disease)

- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
of disease

- 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

- Patients with a known hypersensitivity to olaparib, durvalumab or any of the
excipients of these products and to the combination/comparator agents

- Breast feeding women
We found this trial at
28
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