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 Jul 2024 by AstraZeneca
AstraZeneca
European Network of Gynaecological Oncology Trial Groups (ENGOT), GOG Foundation, Inc. (GOG Foundation), Myriad Genetic Laboratories, Inc.
No locations available
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 |