Ovarian Cancer Clinical Trial
Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients
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.
Full 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.
Eligibility Criteria
Key Inclusion Criteria:
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
Key Exclusion Criteria:
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
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
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There are 215 Locations for this study
Foothill Ranch California, 92610, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
San Francisco California, 94158, United States
Tampa Florida, 33612, United States
Augusta Georgia, 30912, United States
Hinsdale Illinois, 60521, United States
Indianapolis Indiana, 46202, United States
Towson Maryland, 21204, United States
Detroit Michigan, 48202, United States
Springfield Missouri, 65807, United States
Middletown New Jersey, 07748, United States
Montvale New Jersey, 07645, United States
Albany New York, 12208, United States
New York New York, 10065, United States
Uniondale New York, 11553, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44195, United States
Dayton Ohio, 45429, United States
Hilliard Ohio, 43026, United States
Tulsa Oklahoma, 74134, United States
Lancaster Pennsylvania, 17601, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15224, United States
Salt Lake City Utah, 84112, United States
Graz , 8036, Austria
Innsbruck , 6020, Austria
Linz , 4020, Austria
Wien , 1090, Austria
Aalst , 9300, Belgium
Leuven , 3000, Belgium
Namur , 5000, Belgium
Oostende , 8400, Belgium
Sint-Niklaas , 9100, Belgium
Barretos , 14784, Brazil
Florianópolis , 88034, Brazil
Fortaleza , 60810, Brazil
Londrina , 86015, Brazil
Porto Alegre , 90020, Brazil
Porto Alegre , 90110, Brazil
Rio de Janeiro , 20220, Brazil
Sao Paulo , 01317, Brazil
São Paulo , 04014, Brazil
Burgas , 8000, Bulgaria
Plovdiv , 4004, Bulgaria
Sofia , 1330, Bulgaria
Varna , 9000, Bulgaria
Calgary Alberta, T2N 4, Canada
Barrie Ontario, L4M 6, Canada
Hamilton Ontario, L8V 5, Canada
Sudbury Ontario, P3E 5, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2X 3, Canada
Montreal Quebec, H3T 1, Canada
Montreal Quebec, H4A 3, Canada
Rimouski Quebec, G5L 5, Canada
Quebec , G1J 1, Canada
Beijing , CN-10, China
Beijing , , China
Bengbu , 23306, China
Changchun , 13002, China
Changsha , 41000, China
Changsha , 43003, China
Chengdu , 61004, China
Chongqing , 40003, China
Dalian , 11600, China
Guangzhou , 51006, China
Guangzhou , 51008, China
Guangzhou , 51028, China
Hangzhou , 31000, China
Hangzhou , 31002, China
Hangzhou , 31002, China
Harbin , 15008, China
Hefei , 23003, China
Jinhua , 32109, China
Kunming , 65010, China
Kunming , 65011, China
Lanzhou , 73003, China
Luzhou , 64609, China
Nan Chong , 63700, China
Nanjing , 21000, China
Nanjing , 21002, China
Nanning , 53002, China
Nantong , 22636, China
Shanghai , 20001, China
Shanghai , 20003, China
Wuhan , 43003, China
Wuhan , 43006, China
Xi'an , 71006, China
Zhengzhou , 45000, China
Zhengzhou , 45000, China
Zhuhai , 51909, China
Aalborg , 9000, Denmark
Aarhus N , 8200, Denmark
Odense C , 5000, Denmark
Roskilde , 4000, Denmark
Vejle , 7100, Denmark
Kuopio , 70210, Finland
Oulu , 90029, Finland
Turku , 20521, Finland
Besançon , 25000, France
Bordeaux , 33076, France
Limoges Cedex , 87042, France
Lyon Cedex 08 , 69373, France
Marseille , 13273, France
Nantes , 44202, France
Paris Cedex 14 , 75674, France
Paris , 75012, France
Paris , 75015, France
Saint Herblain Cedex , 44805, France
Vandoeuvre les Nancy , 54519, France
Bad Homburg , 61352, Germany
Berlin , 10117, Germany
Bielefeld , 33604, Germany
Bonn , 53105, Germany
Brandenburg , 14770, Germany
Dresden , 1307, Germany
Düsseldorf , 40489, Germany
Essen , 45136, Germany
Essen , 45147, Germany
Esslingen am Neckar , 73730, Germany
Frankfurt , 60590, Germany
Freiburg , 79106, Germany
Fürth , 90766, Germany
Greifswald , 17475, Germany
Gütersloh , 33332, Germany
Hamburg , 20246, Germany
Hamburg , 20357, Germany
Hamburg , 22457, Germany
Hannover , 30177, Germany
Hannover , 30625, Germany
Jena , 07747, Germany
Karlsruhe , 76133, Germany
Karlsruhe , 76135, Germany
Kassel , 34125, Germany
Kiel , 24105, Germany
Köln , 50935, Germany
Leipzig , 04103, Germany
Ludwigsburg , 71640, Germany
Lübeck , 23538, Germany
Mainz , 55131, Germany
Mannheim , 68167, Germany
München , 81377, Germany
Offenbach am Main , 63069, Germany
Oldenburg , 26133, Germany
Rosenheim , 83022, Germany
Rostock , 18057, Germany
Saalfeld , 07318, Germany
Schweinfurt , 97422, Germany
Tübingen , 72016, Germany
Ulm , 89075, Germany
Worms , 67550, Germany
Budapest , 1062, Hungary
Budapest , 1122, Hungary
Debrecen , 4032, Hungary
Győr , 9024, Hungary
Kaposvár , 7400, Hungary
Szeged , 6725, Hungary
Zalaegerszeg , 8900, Hungary
Brescia , 25123, Italy
Lecce , 73100, Italy
Lecco , 23900, Italy
Milano , 20132, Italy
Milano , 20141, Italy
Mirano , 30035, Italy
Napoli , 80131, Italy
Reggio Calabria , 89100, Italy
Reggio Emilia , 42100, Italy
Roma , 00168, Italy
Torino , 10126, Italy
Torino , 10128, Italy
Fukuoka-shi , 811-1, Japan
Kashiwa-shi , 277-8, Japan
Kobe-shi , 650-0, Japan
Koto-ku , 135-8, Japan
Kurume-shi , 830-0, Japan
Kyoto-shi , 606-8, Japan
Minato-ku , 105-8, Japan
Nagoya-shi , 464-8, Japan
Niigata-shi , 951-8, Japan
Okayama-shi , 700-8, Japan
Sapporo-shi , 003-0, Japan
Sendai-shi , 980-8, Japan
Shinjuku-ku , 160-8, Japan
Sunto-gun , 411-8, Japan
Toyoake-shi , 470-1, Japan
Goyang-si , 10408, Korea, Republic of
Seongnam-si , 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Suwon-si , 16499, Korea, Republic of
Bellavista , CALLA, Peru
La Libertad , 13013, Peru
Lima , LIMA , Peru
Lima , Lima , Peru
Lima , LIMA , Peru
Lima , LIMA , Peru
San Isidro , 27, Peru
Gdynia , 81-51, Poland
Szczecin , 70-11, Poland
Warszawa , 02-78, Poland
Warszawa , 04-14, Poland
Łódź , 93-51, Poland
Bucuresti , 01117, Romania
Constanta , 90059, Romania
Floresti , 40728, Romania
Iasi , 70048, Romania
Suceava , 72023, Romania
Timisoara , 30023, Romania
Córdoba , 14004, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Terrassa(Barcelona) , 08221, Spain
Vigo , 36312, Spain
Adana , 1260, Turkey
Ankara , 06230, Turkey
Ankara , 06490, Turkey
Istanbul , 34093, Turkey
Istanbul , 34384, Turkey
Izmir , 35100, Turkey
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