Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients
NCT ID: NCT03737643
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1407 participants
INTERVENTIONAL
2019-01-04
2028-03-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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).
Bevacizumab
Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice.
Placebo olaparib
Placebo tablets to match olaparib
Durvalumab placebo
Matching placebo for intravenous infusion
Carboplatin+Paclitaxel
Standard of care chemotherapy
Arm 2
Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib placebo.
Bevacizumab
Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice.
Durvalumab
Durvalumab by intravenous infusion
Placebo olaparib
Placebo tablets to match olaparib
Carboplatin+Paclitaxel
Standard of care chemotherapy
Arm 3
Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib.
Bevacizumab
Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice.
Durvalumab
Durvalumab by intravenous infusion
Olaparib
Olaparib tablets
Carboplatin+Paclitaxel
Standard of care chemotherapy
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.
Bevacizumab
Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice.
Durvalumab
Durvalumab by intravenous infusion
Olaparib
Olaparib tablets
Carboplatin+Paclitaxel
Standard of care chemotherapy
Interventions
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Bevacizumab
Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice.
Durvalumab
Durvalumab by intravenous infusion
Olaparib
Olaparib tablets
Placebo olaparib
Placebo tablets to match olaparib
Durvalumab placebo
Matching placebo for intravenous infusion
Carboplatin+Paclitaxel
Standard of care chemotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
130 Years
FEMALE
No
Sponsors
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European Network of Gynaecological Oncological Trial Groups (ENGOT)
OTHER
GOG Foundation, Inc. (GOG Foundation)
UNKNOWN
Myriad Genetic Laboratories, Inc.
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Philipp Harter
Role: PRINCIPAL_INVESTIGATOR
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Carol Aghajanian
Role: PRINCIPAL_INVESTIGATOR
GOG
Locations
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Research Site
Foothill Ranch, California, United States
Research Site
Los Angeles, California, United States
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Orange, California, United States
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San Francisco, California, United States
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Tampa, Florida, United States
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Augusta, Georgia, United States
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Hinsdale, Illinois, United States
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Indianapolis, Indiana, United States
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Towson, Maryland, United States
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Detroit, Michigan, United States
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Springfield, Missouri, United States
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Middletown, New Jersey, United States
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Montvale, New Jersey, United States
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Albany, New York, United States
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New York, New York, United States
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Uniondale, New York, United States
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Durham, North Carolina, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Hilliard, Ohio, United States
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Tulsa, Oklahoma, United States
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Lancaster, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Salt Lake City, Utah, United States
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Graz, , Austria
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Innsbruck, , Austria
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Linz, , Austria
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Vienna, , Austria
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Aalst, , Belgium
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Leuven, , Belgium
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Namur, , Belgium
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Ostend, , Belgium
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Sint-Niklaas, , Belgium
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Barretos, , Brazil
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Florianópolis, , Brazil
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Fortaleza, , Brazil
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Londrina, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Burgas, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Calgary, Alberta, Canada
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Barrie, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Rimouski, Quebec, Canada
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Beijing, , China
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Beijing, , China
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Bengbu, , China
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Changchun, , China
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Changsha, , China
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Changsha, , China
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Chengdu, , China
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Chongqing, , China
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Dalian, , China
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Guangzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Harbin, , China
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Hefei, , China
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Jinhua, , China
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Kunming, , China
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Lanzhou, , China
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Luzhou, , China
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Nanchong, , China
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Nanjing, , China
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Nanning, , China
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Nantong, , China
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Shanghai, , China
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Shanghai, , China
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Wuhan, , China
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Wuhan, , China
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Xi'an, , China
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Zhengzhou, , China
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Zhengzhou, , China
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Zhuhai, , China
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Aalborg, , Denmark
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Aarhus N, , Denmark
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Odense, , Denmark
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Roskilde, , Denmark
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Vejle, , Denmark
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Kuopio, , Finland
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Oulu, , Finland
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Turku, , Finland
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Besançon, , France
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Bordeaux, , France
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Limoges, , France
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Lyon, , France
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Marseille, , France
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Nantes, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Saint-Herblain, , France
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Vandœuvre-lès-Nancy, , France
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Bad Homburg, , Germany
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Berlin, , Germany
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Bielefeld, , Germany
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Bonn, , Germany
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Brandenburg, , Germany
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Cologne, , Germany
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Dresden, , Germany
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Düsseldorf, , Germany
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Essen, , Germany
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Essen, , Germany
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Esslingen am Neckar, , Germany
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Frankfurt, , Germany
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Freiburg im Breisgau, , Germany
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Fürth, , Germany
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Greifswald, , Germany
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Gütersloh, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Hanover, , Germany
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Jena, , Germany
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Karlsruhe, , Germany
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Karlsruhe, , Germany
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Kassel, , Germany
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Kiel, , Germany
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Leipzig, , Germany
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Ludwigsburg, , Germany
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Lübeck, , Germany
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Mainz, , Germany
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Mannheim, , Germany
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München, , Germany
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Offenbach, , Germany
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Oldenburg, , Germany
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Rosenheim, , Germany
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Rostock, , Germany
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Saalfeld, , Germany
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Schweinfurt, , Germany
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Tübingen, , Germany
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Ulm, , Germany
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Worms, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Győr, , Hungary
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Kaposvár, , Hungary
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Szeged, , Hungary
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Zalaegerszeg, , Hungary
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Brescia, , Italy
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Lecce, , Italy
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Lecco, , Italy
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Milan, , Italy
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Milan, , Italy
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Mirano, , Italy
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Napoli, , Italy
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Reggio Calabria, , Italy
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Reggio Emilia, , Italy
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Roma, , Italy
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Torino, , Italy
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Torino, , Italy
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Fukuoka, , Japan
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Kashiwa-shi, , Japan
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Kobe, , Japan
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Kōtoku, , Japan
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Kurume-shi, , Japan
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Kyoto, , Japan
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Minatoku, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Okayama, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Shinjuku-ku, , Japan
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Sunto-gun, , Japan
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Toyoake-shi, , Japan
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Bellavista, , Peru
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La Libertad, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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San Isidro, , Peru
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Gdynia, , Poland
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Lodz, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Floreşti, , Romania
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Goyang-si, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Córdoba, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Terrassa(Barcelona), , Spain
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Vigo, , Spain
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
Countries
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References
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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.
Other Identifiers
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2017-004632-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D081RC00001
Identifier Type: -
Identifier Source: org_study_id
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