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Brief Title: Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients
Official Title: 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).
Study ID: NCT03737643
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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Research Site, Foothill Ranch, California, United States
Research Site, Los Angeles, California, United States
Research Site, Orange, California, United States
Research Site, San Francisco, California, United States
Research Site, Tampa, Florida, United States
Research Site, Augusta, Georgia, United States
Research Site, Hinsdale, Illinois, United States
Research Site, Indianapolis, Indiana, United States
Research Site, Towson, Maryland, United States
Research Site, Detroit, Michigan, United States
Research Site, Springfield, Missouri, United States
Research Site, Middletown, New Jersey, United States
Research Site, Montvale, New Jersey, United States
Research Site, Albany, New York, United States
Research Site, New York, New York, United States
Research Site, Uniondale, New York, United States
Research Site, Durham, North Carolina, United States
Research Site, Cleveland, Ohio, United States
Research Site, Dayton, Ohio, United States
Research Site, Hilliard, Ohio, United States
Research Site, Tulsa, Oklahoma, United States
Research Site, Lancaster, Pennsylvania, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Salt Lake City, Utah, United States
Research Site, Graz, , Austria
Research Site, Innsbruck, , Austria
Research Site, Linz, , Austria
Research Site, Wien, , Austria
Research Site, Aalst, , Belgium
Research Site, Leuven, , Belgium
Research Site, Namur, , Belgium
Research Site, Oostende, , Belgium
Research Site, Sint-Niklaas, , Belgium
Research Site, Barretos, , Brazil
Research Site, Florianópolis, , Brazil
Research Site, Fortaleza, , Brazil
Research Site, Londrina, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Rio de Janeiro, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, São Paulo, , Brazil
Research Site, Burgas, , Bulgaria
Research Site, Plovdiv, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Varna, , Bulgaria
Research Site, Calgary, Alberta, Canada
Research Site, Barrie, Ontario, Canada
Research Site, Sudbury, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Rimouski, Quebec, Canada
Research Site, Quebec, , Canada
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Bengbu, , China
Research Site, Changchun, , China
Research Site, Changsha, , China
Research Site, Changsha, , China
Research Site, Chengdu, , China
Research Site, Chongqing, , China
Research Site, Dalian, , China
Research Site, Guangzhou, , China
Research Site, Guangzhou, , China
Research Site, Hangzhou, , China
Research Site, Hangzhou, , China
Research Site, Harbin, , China
Research Site, Hefei, , China
Research Site, Jinhua, , China
Research Site, Kunming, , China
Research Site, Lanzhou, , China
Research Site, Luzhou, , China
Research Site, Nan Chong, , China
Research Site, Nanjing, , China
Research Site, Nanning, , China
Research Site, Nantong, , China
Research Site, Shanghai, , China
Research Site, Shanghai, , China
Research Site, Wuhan, , China
Research Site, Wuhan, , China
Research Site, Xi'an, , China
Research Site, Zhengzhou, , China
Research Site, Zhengzhou, , China
Research Site, Zhuhai, , China
Research Site, Aalborg, , Denmark
Research Site, Aarhus N, , Denmark
Research Site, Odense C, , Denmark
Research Site, Roskilde, , Denmark
Research Site, Vejle, , Denmark
Research Site, Kuopio, , Finland
Research Site, Oulu, , Finland
Research Site, Turku, , Finland
Research Site, Besançon, , France
Research Site, Bordeaux, , France
Research Site, Limoges Cedex, , France
Research Site, Lyon Cedex 08, , France
Research Site, Marseille, , France
Research Site, Nantes, , France
Research Site, Paris Cedex 14, , France
Research Site, Paris, , France
Research Site, Paris, , France
Research Site, Saint Herblain Cedex, , France
Research Site, Vandoeuvre les Nancy, , France
Research Site, Bad Homburg, , Germany
Research Site, Berlin, , Germany
Research Site, Bielefeld, , Germany
Research Site, Bonn, , Germany
Research Site, Brandenburg, , Germany
Research Site, Dresden, , Germany
Research Site, Düsseldorf, , Germany
Research Site, Essen, , Germany
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Research Site, Esslingen am Neckar, , Germany
Research Site, Frankfurt, , Germany
Research Site, Freiburg, , Germany
Research Site, Fürth, , Germany
Research Site, Greifswald, , Germany
Research Site, Gütersloh, , Germany
Research Site, Hamburg, , Germany
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Research Site, Hannover, , Germany
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Research Site, Jena, , Germany
Research Site, Karlsruhe, , Germany
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Research Site, Kassel, , Germany
Research Site, Kiel, , Germany
Research Site, Köln, , Germany
Research Site, Leipzig, , Germany
Research Site, Ludwigsburg, , Germany
Research Site, Lübeck, , Germany
Research Site, Mainz, , Germany
Research Site, Mannheim, , Germany
Research Site, München, , Germany
Research Site, Offenbach am Main, , Germany
Research Site, Oldenburg, , Germany
Research Site, Rosenheim, , Germany
Research Site, Rostock, , Germany
Research Site, Saalfeld, , Germany
Research Site, Schweinfurt, , Germany
Research Site, Tübingen, , Germany
Research Site, Ulm, , Germany
Research Site, Worms, , Germany
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Debrecen, , Hungary
Research Site, Győr, , Hungary
Research Site, Kaposvár, , Hungary
Research Site, Szeged, , Hungary
Research Site, Zalaegerszeg, , Hungary
Research Site, Brescia, , Italy
Research Site, Lecce, , Italy
Research Site, Lecco, , Italy
Research Site, Milano, , Italy
Research Site, Milano, , Italy
Research Site, Mirano, , Italy
Research Site, Napoli, , Italy
Research Site, Reggio Calabria, , Italy
Research Site, Reggio Emilia, , Italy
Research Site, Roma, , Italy
Research Site, Torino, , Italy
Research Site, Torino, , Italy
Research Site, Fukuoka-shi, , Japan
Research Site, Kashiwa-shi, , Japan
Research Site, Kobe-shi, , Japan
Research Site, Koto-ku, , Japan
Research Site, Kurume-shi, , Japan
Research Site, Kyoto-shi, , Japan
Research Site, Minato-ku, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Niigata-shi, , Japan
Research Site, Okayama-shi, , Japan
Research Site, Sapporo-shi, , Japan
Research Site, Sendai-shi, , Japan
Research Site, Shinjuku-ku, , Japan
Research Site, Sunto-gun, , Japan
Research Site, Toyoake-shi, , Japan
Research Site, Goyang-si, , Korea, Republic of
Research Site, Seongnam-si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Suwon-si, , Korea, Republic of
Research Site, Bellavista, , Peru
Research Site, La Libertad, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
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Research Site, San Isidro, , Peru
Research Site, Gdynia, , Poland
Research Site, Szczecin, , Poland
Research Site, Warszawa, , Poland
Research Site, Warszawa, , Poland
Research Site, Łódź, , Poland
Research Site, Floresti, , Romania
Research Site, Córdoba, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
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Research Site, Madrid, , Spain
Research Site, Terrassa(Barcelona), , Spain
Research Site, Vigo, , Spain
Research Site, Adana, , Turkey
Research Site, Ankara, , Turkey
Research Site, Ankara, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Izmir, , Turkey
Name: Philipp Harter
Affiliation: European Network of Gynaecological Oncological Trial Groups (ENGOT)
Role: PRINCIPAL_INVESTIGATOR
Name: Carol Aghajanian
Affiliation: GOG
Role: PRINCIPAL_INVESTIGATOR