Ovarian Cancer Clinical Trial
A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Summary
This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.
Eligibility Criteria
Inclusion Criteria:
Participants receiving a histologic diagnosis of epithelial ovarian cancer (EOC), peritoneal primary carcinoma, or fallopian tube cancer
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Life expectancy greater than (>) 12 weeks
For participants who receive therapeutic anticoagulation: stable anticoagulant regimen
Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in paraffin blocks (preferred) or at least 20 unstained slides (for detailed tissue requirements at screening)
Exclusion Criteria:
Received a current diagnosis of borderline epithelial ovarian tumor (formerly tumors of low malignant potential)
Have recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer that was treated only with surgery (example [e.g.], participants with Stage IA or Stage IB epithelial ovarian or fallopian tube cancers)
Have non-epithelial ovarian tumors (e.g., germ cell tumors, sex cord stromal tumors)
Received prior radiotherapy to any portion of the abdominal cavity or pelvis
Received prior chemotherapy for any abdominal or pelvic tumor that include neoadjuvant chemotherapy (NACT) for ovarian, primary peritoneal or fallopian tube cancer
Received any biological and/or targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management and/or treatment of epithelial ovarian or peritoneal primary cancer
Have synchronous primary endometrial cancer
Have a prior history of primary endometrial cancer, except: Stage IA cancer; superficial myometrial invasion, without lymphovascular invasion; grade less than (<) 3 or poorly differentiated subtypes, and this includes papillary serous, clear cell or other International Federation of Gynecological Oncologists (FIGO) Grade 3 lesions
With the exception of non-melanoma skin cancer and other specific malignancies as noted above, other invasive malignancies with any evidence of other cancers present within the last 5 years or previous cancer treatment that contraindicates this protocol therapy
Have a known hypersensitivity or allergy to biopharmaceutical agents produced in Chinese hamster ovary cells or any component of the atezolizumab and/or bevacizumab formulations
Undergo major surgical procedure within 28 days prior to first bevacizumab dose, or anticipation of the need for a major surgical procedure during the course of the study except participants who receive NACT and will need interval surgery. This may include but is not limited to laparotomy.
Have prior allogeneic bone marrow transplantation or solid organ transplant
Have any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results
Have any approved or investigational anti-cancer therapy, including chemotherapy or hormonal therapy, with exceptions: Hormone-replacement therapy or oral contraceptives
Are administered treatment with any other investigational agent or participation in another clinical study with anti-cancer therapeutic intent
Have core biopsy or other minor surgical procedures within 7 days prior to the first dose of bevacizumab
Have known sensitivity to any component of bevacizumab
Have known sensitivity to any component of paclitaxel
Current treatment with anti-viral therapy for hepatitis B virus (HBV)
History of leptomeningeal disease
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There are 258 Locations for this study
Phoenix Arizona, 85013, United States
Scottsdale Arizona, 85258, United States
Tucson Arizona, 85710, United States
La Jolla California, 92093, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
Oakland California, 94611, United States
Orange California, 92868, United States
Orange California, 92868, United States
Palo Alto California, 94305, United States
Roseville California, 95661, United States
San Diego California, 92108, United States
San Francisco California, 94115, United States
San Francisco California, 94115, United States
San Francisco California, 94158, United States
Santa Clara California, 95051, United States
Sylmar California, 91342, United States
Walnut Creek California, 94596, United States
Aurora Colorado, 80045, United States
Danbury Connecticut, 06810, United States
Norwich Connecticut, 06360, United States
Miami Florida, 33136, United States
Miami Florida, 33176, United States
Saint Petersburg Florida, 33701, United States
Sarasota Florida, 34239, United States
Atlanta Georgia, 30342, United States
Gainesville Georgia, 30501, United States
Honolulu Hawaii, 96826, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Hinsdale Illinois, 60521, United States
Fort Wayne Indiana, 46845, United States
Indianapolis Indiana, 46260, United States
Iowa City Iowa, 52242, United States
Lexington Kansas, 40536, United States
Edgewood Kentucky, 41017, United States
Baton Rouge Louisiana, 70817, United States
Scarborough Maine, 04074, United States
Baltimore Maryland, 21204, United States
Baltimore Maryland, 21215, United States
Baltimore Maryland, 21237, United States
Frederick Maryland, 21701, United States
Boston Massachusetts, 02114, United States
Springfield Massachusetts, 01199, United States
Ann Arbor Michigan, 48106, United States
Detroit Michigan, 48201, United States
Traverse City Michigan, 49684, United States
Bemidji Minnesota, 56601, United States
Minneapolis Minnesota, 55455, United States
Saint Louis Park Minnesota, 55416, United States
Woodbury Minnesota, 55125, United States
Jackson Mississippi, 39216, United States
Saint Louis Missouri, 63108, United States
Billings Montana, 59101, United States
Missoula Montana, 59804, United States
Omaha Nebraska, 68114, United States
Omaha Nebraska, 68198, United States
Las Vegas Nevada, 89106, United States
Reno Nevada, 89511, United States
Lebanon New Hampshire, 03756, United States
Basking Ridge New Jersey, 07920, United States
Camden New Jersey, 08103, United States
Hackensack New Jersey, 07601, United States
Middletown New Jersey, 07748, United States
Neptune New Jersey, 07753, United States
Teaneck New Jersey, 07666, United States
Albuquerque New Mexico, 87106, United States
Albuquerque New Mexico, 87106, United States
Albany New York, 12208, United States
Flushing New York, 11355, United States
Lake Success New York, 11042, United States
New York New York, 10016, United States
New York New York, 10029, United States
New York New York, 10029, United States
New York New York, 11101, United States
Rockville Centre New York, 11570, United States
Charlotte North Carolina, 28204, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27103, United States
Winston-Salem North Carolina, 27157, United States
Bismarck North Dakota, 58506, United States
Fargo North Dakota, 58102, United States
Cincinnati Ohio, 45203, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44111, United States
Columbus Ohio, 43125, United States
Columbus Ohio, 43210, United States
Kettering Ohio, 45429, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74146, United States
Springfield Oregon, 97477, United States
Tigard Oregon, 97223, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19140, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15224, United States
Willow Grove Pennsylvania, 19090, United States
York Pennsylvania, 17403, United States
Providence Rhode Island, 02905, United States
Greenville South Carolina, 29607, United States
Rapid City South Dakota, 57701, United States
Sioux Falls South Dakota, 57105, United States
Austin Texas, 78701, United States
Austin Texas, 78731, United States
Bedford Texas, 76022, United States
Dallas Texas, 75390, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Irving Texas, 75063, United States
San Antonio Texas, 78240, United States
The Woodlands Texas, 77060, United States
Tyler Texas, 75702, United States
Saint George Utah, 84790, United States
Salt Lake City Utah, 84112, United States
Charlottesville Virginia, 22906, United States
Fairfax Virginia, 22031, United States
Norfolk Virginia, 23502, United States
Richmond Virginia, 23229, United States
Winchester Virginia, 22601, United States
Seattle Washington, 98195, United States
Madison Wisconsin, 53792, United States
Mukwonago Wisconsin, 53149, United States
Wausau Wisconsin, 54401, United States
St Leonards New South Wales, 2065, Australia
Malvern Victoria, 3144, Australia
North Melbourne Victoria, 3051, Australia
Graz , 8020, Austria
Innsbruck , 6020, Austria
Salzburg , 5020, Austria
Wien , 1090, Austria
Gent , 9000, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Wilrijk , 2610, Belgium
Rio de Janeiro RJ, 20560, Brazil
Sao Paulo SP, 01317, Brazil
Beijing City , 10003, China
Beijing , 10014, China
Chengdu City , 61006, China
Chongqing , 40003, China
Guangzhou City , 51066, China
Hangzhou , 31000, China
Harbin , 15008, China
Nanjing City , 21002, China
Nanjing , 21000, China
Nanning , 53002, China
Shanghai City , 20012, China
Tianjin City , 30005, China
Zhejiang , 31002, China
Zhengzhou , 45000, China
Olomouc , 779 0, Czechia
Ostrava-Poruba , 70852, Czechia
Prague , 120 0, Czechia
Praha 5 , 15006, Czechia
København Ø , 2100, Denmark
Kuopio , 70211, Finland
Tampere , 33520, Finland
Turku , 20521, Finland
Avignon , 84918, France
Le Mans , 72000, France
Lyon , 69373, France
Nantes , 44202, France
Paris , 75571, France
Pierre Benite , 69495, France
St Cloud , 92210, France
Villejuif , 94805, France
Berlin , 13353, Germany
Dresden , 01307, Germany
Essen , 45122, Germany
Essen , 45136, Germany
Freiburg , 79106, Germany
Greifswald , 17475, Germany
Hamburg , 20246, Germany
Hannover , 30625, Germany
Heidelberg , 69120, Germany
Konstanz , 78464, Germany
Lübeck , 23538, Germany
Mainz , 55131, Germany
Muenchen , 81377, Germany
München , 81675, Germany
Rostock , 18059, Germany
Ulm , 89075, Germany
Wiesbaden , 65199, Germany
Athens , 115 2, Greece
Ioannina , 455 0, Greece
Kifisia , 145 6, Greece
Patras , 265 0, Greece
Thessaloniki , 546 4, Greece
Hadera , 38101, Israel
Jerusalem , 91031, Israel
Kfar Saba , 44281, Israel
Ramat Gan , 52621, Israel
Rehovot , 76100, Israel
Napoli Campania, 80131, Italy
Napoli Campania, 80131, Italy
Bologna Emilia-Romagna, 40138, Italy
Faenza Emilia-Romagna, 48018, Italy
Meldola Emilia-Romagna, 47014, Italy
Reggio Emilia Emilia-Romagna, 42100, Italy
Roma Lazio, 00168, Italy
Brescia Lombardia, 25123, Italy
Milano Lombardia, 20132, Italy
Milano Lombardia, 20133, Italy
Milano Lombardia, 20141, Italy
Milano Lombardia, 20162, Italy
Monza Lombardia, 20052, Italy
Torino Piemonte, 10126, Italy
Torino Piemonte, 10128, Italy
Brindisi Puglia, 72100, Italy
Perugia Umbria, 06123, Italy
Padova Veneto, 35128, Italy
Aichi , 466-8, Japan
Ehime , 791-0, Japan
Ehime , 791-0, Japan
Fukuoka , 811-1, Japan
Fukuoka , 812-8, Japan
Fukuoka , 830-0, Japan
Hiroshima , 737-0, Japan
Hokkaido , 003-0, Japan
Hyogo , 673-0, Japan
Iwate , 028-3, Japan
Kagoshima , 890-8, Japan
Kanagawa , 236-0, Japan
Kyoto , 606-8, Japan
Mie , 514-8, Japan
Miyagi , 980-8, Japan
Niigata , 951-8, Japan
Osaka , 541-8, Japan
Shizuoka , 411-8, Japan
Tokyo , 105-8, Japan
Tokyo , 113-8, Japan
Tokyo , 135-8, Japan
Tokyo , 160-8, Japan
Goyang-si , 10408, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Oslo , 0310, Norway
Trondheim , 7006, Norway
Krakow , 31-11, Poland
Pozna? , 60-56, Poland
Szczecin , 70-11, Poland
Warszawa , 02-78, Poland
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
Kazan , 42002, Russian Federation
Moscow , 10522, Russian Federation
Saint-Petersburg , 19702, Russian Federation
Sabadell Barcelona, 8208, Spain
Palma de Mallorca Islas Baleares, 07010, Spain
Alcorcon Madrid, 28922, Spain
Barcelona , 08028, Spain
Madrid , 28007, Spain
Madrid , 28050, Spain
Malaga , 29010, Spain
Valencia , 46026, Spain
Zaragoza , 50009, Spain
Linköping , 58185, Sweden
Stockholm , 171 7, Sweden
Adana , 01230, Turkey
Ankara , 06100, Turkey
Ankara , 06490, Turkey
Istanbul , 34010, Turkey
Istanbul , 34093, Turkey
Istanbul , 34098, Turkey
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