Study identifier:D081RC00001
ClinicalTrials.gov identifier:NCT03737643
EudraCT identifier:2017-004632-11
CTIS identifier:2022-502747-35-00
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).
Advanced Ovarian cancer
Phase 3
No
Bevacizumab, Durvalumab, Olaparib, Placebo olaparib, Durvalumab placebo, Carboplatin+Paclitaxel
Female
1407
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jan 2025 by AstraZeneca
AstraZeneca
European Network of Gynaecological Oncology Trial Groups (ENGOT), GOG Foundation, Inc. (GOG Foundation), Myriad Genetic Laboratories, Inc.
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.
Location
Location
New York, NY, United States, 10065
Location
Essen, Germany, 45136
Location
Oldenburg, Germany, 26133
Location
Augusta, GA, United States, 30912
Location
Hinsdale, IL, United States, 60521
Location
Indianapolis, IN, United States, 46202
Location
Kyoto-shi, Japan, 606-8507
Location
Köln, Germany, 50935
Arms | Assigned Interventions |
---|---|
Active Comparator: Arm 1 Platinum-based chemotherapy in combination with bevacizumab and durvalumab placebo (saline IV infusion) followed by maintenance bevacizumab, durvalumab placebo (saline IV infusion) and olaparib placebo (tablets). | Drug: Bevacizumab Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice. Drug: Placebo olaparib Placebo tablets to match olaparib Drug: Durvalumab placebo Matching placebo for intravenous infusion Drug: Carboplatin+Paclitaxel Standard of care chemotherapy |
Experimental: Arm 2 Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib placebo. | Drug: Bevacizumab Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice. Drug: Durvalumab Durvalumab by intravenous infusion Drug: Placebo olaparib Placebo tablets to match olaparib Drug: Carboplatin+Paclitaxel Standard of care chemotherapy |
Experimental: Arm 3 Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib. | Drug: Bevacizumab Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice. Drug: Durvalumab Durvalumab by intravenous infusion Drug: Olaparib Olaparib tablets Drug: Carboplatin+Paclitaxel Standard of care chemotherapy |
Experimental: tBRCAm cohort Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib. Bevacizumab is optional according to local practice. | Drug: Bevacizumab Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice. Drug: Durvalumab Durvalumab by intravenous infusion Drug: Olaparib Olaparib tablets Drug: Carboplatin+Paclitaxel Standard of care chemotherapy |
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