Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients
DUO-O
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).
2 other identifiers
interventional
1,407
20 countries
214
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2019
Longer than P75 for phase_3
214 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2018
CompletedFirst Posted
Study publicly available on registry
November 9, 2018
CompletedStudy Start
First participant enrolled
January 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2028
ExpectedJanuary 29, 2025
January 1, 2025
6.2 years
October 15, 2018
January 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression Free Survival (PFS) - in non-tBRCA HRD positive patients
Defined as time from randomisation to first progression by investigator assessment using modified RECIST 1.1 or death (by any cause in the absence of progression)
Approximately 4 years
Progression Free Survival (PFS) - in all non-tBRCA patients
Defined as time from randomisation to first progression by investigator assessment using modified RECIST 1.1 or death (by any cause in the absence of progression)
Approximately 4 years
Secondary Outcomes (21)
Progression Free Survival (PFS) - in non-tBRCAm patients
Approximately 4 years
Overall Survival (OS) - in non-tBRCA HRD positive patients and in all non-tBRCA patients
Approximately 7 years
Second Progression (PFS2) - in non-tBRCAm patients
Approximately 7 years
Health-related quality of life - in non-tBRCAm patients
Approximately 4 years
Pathological Complete Response (pCR) - in non-tBRCAm patients
Approximately 4 years
- +16 more secondary outcomes
Other Outcomes (1)
Safety and tolerability of drugs by assessment of AEs/SAEs
Approximately 4 years
Study Arms (4)
Arm 1
ACTIVE COMPARATORPlatinum-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).
Arm 2
EXPERIMENTALPlatinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib placebo.
Arm 3
EXPERIMENTALPlatinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib.
tBRCAm cohort
EXPERIMENTALPlatinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib. Bevacizumab is optional according to local practice.
Interventions
Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- European Network of Gynaecological Oncological Trial Groups (ENGOT)collaborator
- GOG Foundation, Inc. (GOG Foundation)collaborator
- Myriad Genetic Laboratories, Inc.collaborator
Study Sites (214)
Research Site
Foothill Ranch, California, 92610, United States
Research Site
Los Angeles, California, 90095, United States
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Orange, California, 92868-3298, United States
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San Francisco, California, 94158, United States
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Tampa, Florida, 33612, United States
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Augusta, Georgia, 30912, United States
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Hinsdale, Illinois, 60521, United States
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Indianapolis, Indiana, 46202, United States
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Towson, Maryland, 21204, United States
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Detroit, Michigan, 48202, United States
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Springfield, Missouri, 65807, United States
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Middletown, New Jersey, 07748, United States
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Montvale, New Jersey, 07645, United States
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Albany, New York, 12208, United States
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New York, New York, 10065, United States
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Uniondale, New York, 11553, United States
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Durham, North Carolina, 27710, United States
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Cleveland, Ohio, 44195, United States
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Dayton, Ohio, 45429, United States
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Hilliard, Ohio, 43026, United States
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Tulsa, Oklahoma, 74134, United States
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Lancaster, Pennsylvania, 17601, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19107-5097, United States
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Pittsburgh, Pennsylvania, 15224, United States
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Salt Lake City, Utah, 84112, United States
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Linz, 4020, Austria
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Vienna, 1090, Austria
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Aalst, 9300, Belgium
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Leuven, 3000, Belgium
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Namur, 5000, Belgium
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Ostend, 8400, Belgium
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Sint-Niklaas, 9100, Belgium
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Barretos, 14784-400, Brazil
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Florianópolis, 88034-000, Brazil
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Fortaleza, 60810-180, Brazil
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Londrina, 86015-520, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 90110-270, Brazil
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Rio de Janeiro, 20220-410, Brazil
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São Paulo, 01317-000, Brazil
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São Paulo, 04014-002, Brazil
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Burgas, 8000, Bulgaria
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Plovdiv, 4004, Bulgaria
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Sofia, 1330, Bulgaria
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Varna, 9000, Bulgaria
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Calgary, Alberta, T2N 5G2, Canada
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Barrie, Ontario, L4M 6M2, Canada
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Greater Sudbury, Ontario, P3E 5J1, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H2X 3E4, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Québec, Quebec, G1J 1Z4, Canada
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Rimouski, Quebec, G5L 5T1, Canada
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Beijing, 100026, China
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Beijing, CN-100730, China
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Bengbu, 233060, China
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Changchun, 130021, China
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Changsha, 410008, China
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Changsha, 430033, China
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Chengdu, 610041, China
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Chongqing, 400030, China
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Dalian, 116001, China
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Guangzhou, 510060, China
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Guangzhou, 510080, China
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Hangzhou, 310009, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Hefei, 230031, China
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Jinhua, 321099, China
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Kunming, 650118, China
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Lanzhou, 730030, China
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Luzhou, 646099, China
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Nanchong, 637000, China
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Nanjing, 2100008, China
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Nanning, 530021, China
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Nantong, 226361, China
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Shanghai, 200011, China
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Shanghai, 200032, China
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Wuhan, 430030, China
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Wuhan, 430060, China
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Xi'an, 710061, China
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Zhengzhou, 450002, China
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Zhengzhou, 450008, China
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Zhuhai, 519099, China
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Aalborg, 9000, Denmark
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Aarhus N, 8200, Denmark
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Odense, 5000, Denmark
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Roskilde, 4000, Denmark
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Vejle, 7100, Denmark
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Kuopio, 70210, Finland
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Oulu, 90029, Finland
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Turku, 20521, Finland
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Besançon, 25000, France
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Bordeaux, 33076, France
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Limoges, 87042, France
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Lyon, 69373, France
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Marseille, 13273, France
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Nantes, 44202, France
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Paris, 75012, France
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Paris, 75015, France
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Paris, 75674, France
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Saint-Herblain, 44805, France
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Vandœuvre-lès-Nancy, 54519, France
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Bad Homburg, 61352, Germany
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Berlin, 10117, Germany
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Bielefeld, 33604, Germany
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Bonn, 53105, Germany
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Brandenburg, 14770, Germany
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Cologne, 50935, Germany
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Dresden, 1307, Germany
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Düsseldorf, 40489, Germany
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Essen, 45136, Germany
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Essen, 45147, Germany
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Esslingen am Neckar, 73730, Germany
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Frankfurt, 60590, Germany
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Freiburg im Breisgau, 79106, Germany
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Fürth, 90766, Germany
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Greifswald, 17475, Germany
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Gütersloh, 33332, Germany
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Hamburg, 20246, Germany
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Hamburg, 20357, Germany
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Hamburg, 22457, Germany
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Hanover, 30177, Germany
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Hanover, 30625, Germany
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Jena, 07747, Germany
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Karlsruhe, 76133, Germany
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Karlsruhe, 76135, Germany
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Kassel, 34125, Germany
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Kiel, 24105, Germany
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Leipzig, 04103, Germany
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Ludwigsburg, 71640, Germany
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Lübeck, 23538, Germany
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Mainz, 55131, Germany
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Mannheim, 68167, Germany
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München, 81377, Germany
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Offenbach, 63069, Germany
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Oldenburg, 26133, Germany
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Rosenheim, 83022, Germany
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Rostock, 18057, Germany
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Saalfeld, 07318, Germany
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Schweinfurt, 97422, Germany
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Tübingen, 72016, Germany
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Ulm, 89075, Germany
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Worms, 67550, Germany
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Budapest, 1062, Hungary
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Budapest, 1122, Hungary
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Debrecen, 4032, Hungary
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Győr, 9024, Hungary
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Kaposvár, 7400, Hungary
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Szeged, 6725, Hungary
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Zalaegerszeg, 8900, Hungary
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Brescia, 25123, Italy
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Lecce, 73100, Italy
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Lecco, 23900, Italy
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Milan, 20132, Italy
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Milan, 20141, Italy
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Mirano, 30035, Italy
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Napoli, 80131, Italy
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Reggio Calabria, 89100, Italy
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Reggio Emilia, 42100, Italy
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Roma, 00168, Italy
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Torino, 10126, Italy
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Torino, 10128, Italy
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Fukuoka, 811-1395, Japan
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Kashiwa-shi, 277-8567, Japan
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Kobe, 650-0047, Japan
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Kōtoku, 135-8550, Japan
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Kurume-shi, 830-0011, Japan
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Kyoto, 606-8507, Japan
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Minatoku, 105-8471, Japan
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Nagoya, 464-8681, Japan
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Niigata, 951-8520, Japan
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Okayama, 700-8558, Japan
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Sapporo, 003-0804, Japan
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Sendai, 980-8574, Japan
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Shinjuku-ku, 160-8582, Japan
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Sunto-gun, 411-8777, Japan
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Toyoake-shi, 470-1192, Japan
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Bellavista, CALLAO 2, Peru
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La Libertad, 13013, Peru
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Lima, LIMA 31, Peru
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Lima, Lima 32, Peru
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Lima, LIMA 34, Peru
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Lima, LIMA 41, Peru
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San Isidro, 27, Peru
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Gdynia, 81-519, Poland
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Lodz, 93-513, Poland
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Szczecin, 70-111, Poland
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Warsaw, 02-781, Poland
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Warsaw, 04-141, Poland
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Floreşti, 407280, Romania
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Goyang-si, 10408, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 06351, South Korea
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Suwon, 16499, South Korea
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Córdoba, 14004, Spain
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Madrid, 28033, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Terrassa(Barcelona), 08221, Spain
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Vigo, 36312, Spain
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Adana, 1260, Turkey (Türkiye)
Research Site
Ankara, 06230, Turkey (Türkiye)
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Ankara, 06490, Turkey (Türkiye)
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Istanbul, 34093, Turkey (Türkiye)
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Istanbul, 34384, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
Related Publications (1)
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PMID: 37185961DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philipp Harter
European Network of Gynaecological Oncological Trial Groups (ENGOT)
- PRINCIPAL INVESTIGATOR
Carol Aghajanian
GOG
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2018
First Posted
November 9, 2018
Study Start
January 4, 2019
Primary Completion
March 28, 2025
Study Completion (Estimated)
March 30, 2028
Last Updated
January 29, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.