Ovarian Cancer Clinical Trial
A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
Summary
This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or following neoadjuvant chemotherapy (interval debulking)
Completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the Investigator
Sufficient tumor tissue for planned analysis
ECOG performance status of 0 or 1
Patients must be 20 years of age to consent in Japan, Taiwan and South Korea; in all other participating countries patients must be 18 years of age to consent
Exclusion Criteria:
Pure sarcomas or borderline tumors or mucinous tumors
Active second malignancy
Known central nervous system brain metastases
Any prior treatment for ovarian cancer, other than the first-line platinum regimen
Evidence of interstitial lung disease or active pneumonitis
Active, known or suspected autoimmune disease
Condition requiring active systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications
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There are 190 Locations for this study
Phoenix Arizona, 85016, United States
Tucson Arizona, 85711, United States
Tucson Arizona, 85724, United States
Concord California, 94520, United States
Los Angeles California, 90095, United States
San Francisco California, 94589, United States
Aurora Colorado, 80045, United States
Lakewood Colorado, 80228, United States
New Haven Connecticut, 06520, United States
Fort Myers Florida, 33905, United States
Jacksonville Florida, 32207, United States
Miami Florida, 33176, United States
Orlando Florida, 32804, United States
Atlanta Georgia, 30342, United States
Augusta Georgia, 30912, United States
Chicago Illinois, 60612, United States
Hinsdale Illinois, 60521, United States
Springfield Illinois, 62769, United States
Indianapolis Indiana, 46250, United States
Iowa City Iowa, 52242, United States
Westwood Kansas, 66205, United States
Lexington Kentucky, 40536, United States
Louisville Kentucky, 40241, United States
New Orleans Louisiana, 70121, United States
Scarborough Maine, 04074, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02114, United States
Detroit Michigan, 48201, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Missouri, 63110, United States
Las Vegas Nevada, 89169, United States
Camden New Jersey, 08103, United States
Florham Park New Jersey, 07932, United States
Albany New York, 12008, United States
Johnson City New York, 13790, United States
Lake Success New York, 11042, United States
New York New York, 10016, United States
Chapel Hill North Carolina, 27707, United States
Cincinnati Ohio, 45221, United States
Cincinnati Ohio, 45242, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 44907, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74146, United States
Eugene Oregon, 97401, United States
Portland Oregon, 97210, United States
Portland Oregon, 97225, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15213, United States
Willow Grove Pennsylvania, 19090, United States
Sioux Falls South Dakota, 57105, United States
Austin Texas, 78731, United States
Bedford Texas, 76022, United States
Dallas Texas, 75231, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
San Antonio Texas, 78240, United States
The Woodlands Texas, 77380, United States
Salt Lake City Utah, 84112, United States
Norfolk Virginia, 23502, United States
Milwaukee Wisconsin, 53226, United States
New Lambton Heights New South Wales, 2145, Australia
Saint Leonards New South Wales, 2065, Australia
Sydney New South Wales, 2031, Australia
Westmead New South Wales, 2145, Australia
Brisbane Queensland, 4020, Australia
Toorak Gardens South Australia, 5065, Australia
Melbourne Victoria, 3000, Australia
Subiaco Western Australia, 6005, Australia
Leuven , 3000, Belgium
Calgary Alberta, T2N 1, Canada
Edmonton Alberta, T6G 2, Canada
Abbotsford British Columbia, V2S 0, Canada
Kelowna British Columbia, V1Y 5, Canada
Surrey British Columbia, V3V 1, Canada
Winnipeg Manitoba, R3E 0, Canada
Halifax Nova Scotia, B3H 2, Canada
Hamilton Ontario, LbV 5, Canada
London Ontario, N6A 5, Canada
Ottawa Ontario, K1H 8, Canada
Montréal Quebec, H2X 0, Canada
Montréal Quebec, H4A 3, Canada
Sherbrooke Quebec, J1H 5, Canada
Brno , 65653, Czechia
Prague , , Czechia
Zlín , , Czechia
Aalborg , 9000, Denmark
Odense , 5000, Denmark
Kuopio , 70210, Finland
Dessau , , Germany
Duesseldorf , , Germany
Heidelberg , , Germany
Mannheim , , Germany
Traunstein , , Germany
Chaidari Athens, 12462, Greece
Chaidari Athens, 12462, Greece
Athens , 11528, Greece
Patra , 26335, Greece
Thessaloniki , 5465, Greece
Cork , T12 D, Ireland
Cork , , Ireland
Limerick , V94 F, Ireland
Waterford , X91 E, Ireland
Jerusalem , , Israel
Kfar Saba , 44281, Israel
Nahariya , 22100, Israel
Ramat Gan , 52656, Israel
Safed , 13100, Israel
Tel Aviv , 64239, Israel
Aviano , 33081, Italy
Candiolo , 10060, Italy
Catania , 95122, Italy
Chieti , , Italy
Napoli , 80131, Italy
Roma , 00161, Italy
Roma , 00168, Italy
Roma , 00186, Italy
Vicenza , 36100, Italy
Tsukuba Amakubo, , Japan
Kashiwa Chiba, 277-8, Japan
Kurume Fukuoka, 830-0, Japan
Yokohama Fukuura, , Japan
Maebashi Gunma, 371-8, Japan
Ota-shi Gunma, 373-8, Japan
Naka Hiroshima, 730-0, Japan
Akashi Hyogo, 673-0, Japan
Morioka Iwate, , Japan
Kawasaki-shi Kanagawa, 211-8, Japan
Yokohama Kanagawa, 241-8, Japan
Tokorozawa Namiki, , Japan
Chuo Osaka, 541-8, Japan
Ōsaka-sayama Osaka, 589-8, Japan
Hidaka Saitama, 350-1, Japan
Shinjuku-Ku Shinanomachi, , Japan
Koto-Ku Tokyo, , Japan
Saitama , 362-0, Japan
Takamatsu , , Japan
Tokyo , 104-0, Japan
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Seongnam Gyeonggi-do, 13496, Korea, Republic of
Incheon Seoul, 21565, Korea, Republic of
Cheonan , , Korea, Republic of
Seoul , 01812, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05030, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , , Korea, Republic of
Suwon-si , , Korea, Republic of
Auckland , 1023, New Zealand
Christchurch , 8011, New Zealand
Hamilton , 3204, New Zealand
Palmerston North , 4442, New Zealand
Tauranga , 3112, New Zealand
Warsaw Kondratowicza, , Poland
Bialystok , 20-08, Poland
Białystok , , Poland
Gdynia , 81-51, Poland
Lublin , 20-08, Poland
Poznań , 61-86, Poland
Szczecin , , Poland
Oradea Jud. Bihor, 41046, Romania
Cluj-Napoca Jud. Cluj, 40064, Romania
Baia Mare , , Romania
Bucuresti , , Romania
Cluj-Napoca , , Romania
Craiova , 20034, Romania
Craiova , , Romania
Iaşi , 70048, Romania
Ploieşti , , Romania
Suceava , 72023, Romania
Timişoara , 30023, Romania
Arkhangel'sk , 16304, Russian Federation
Omsk , 64401, Russian Federation
Orenburg , , Russian Federation
Pesochnyy , 19775, Russian Federation
Pyatigorsk , 35750, Russian Federation
Saint Petersburg , 19435, Russian Federation
Saint Petersburg , 19702, Russian Federation
Saint Petersburg , 19825, Russian Federation
Saint Petersburg , , Russian Federation
Saransk , 43003, Russian Federation
Sotchi , 35405, Russian Federation
Singapore , 11908, Singapore
Singapore , , Singapore
Barcelona , 08035, Spain
Barcelona , 08041, Spain
Bilbao , 48013, Spain
Castillón , 12002, Spain
El Palmar , 30120, Spain
Jerez de la Frontera , 11407, Spain
Madrid , 28222, Spain
Oviedo , 33011, Spain
Palma De Mallorca , 07198, Spain
Sevilla , 41014, Spain
Linköping , , Sweden
Lund , , Sweden
Stockholm , , Sweden
Hualien City , , Taiwan
Kaohsiung , 81362, Taiwan
New Taipei City , 22060, Taiwan
Taichung , 40705, Taiwan
Taichung , , Taiwan
Tainan , , Taiwan
Tainan , , Taiwan
Taipei , 10048, Taiwan
Taipei , 10449, Taiwan
Taipei , 11217, Taiwan
Taipei , 11490, Taiwan
Taipei , , Taiwan
Taoyuan , 33305, Taiwan
Ankara , , Turkey
Istanbul , , Turkey
Istanbul , , Turkey
Manisa , 45030, Turkey
Yuregir , , Turkey
Canterbury Kent, CT1 3, United Kingdom
Cliftonville Northampton, NN1 5, United Kingdom
Brighton , BN2 3, United Kingdom
Bristol , BS2 8, United Kingdom
Cambridge , CB2 0, United Kingdom
Edinburgh , EH4 2, United Kingdom
Lancaster , LA1 4, United Kingdom
Leeds , LS9 7, United Kingdom
London , EC1A , United Kingdom
London , NW1 2, United Kingdom
London , SE1 9, United Kingdom
London , SW3 6, United Kingdom
London , W12 0, United Kingdom
Middlesbrough , TS4 3, United Kingdom
Poole , BH15 , United Kingdom
Swansea , SA2 8, United Kingdom
Taunton , TA1 5, United Kingdom
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