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.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

1000

Study ID:

NCT03522246

Recruitment Status:

Active, not recruiting

Sponsor:

pharmaand GmbH

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There are 190 Locations for this study

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Arizona Oncology Associates, PC - HAL
Phoenix Arizona, 85016, United States
Arizona Oncology Associates, PC - HOPE
Tucson Arizona, 85711, United States
The University of Arizona Cancer Center
Tucson Arizona, 85724, United States
John Muir Clinical Research Center
Concord California, 94520, United States
UCLA Women's Health Clinical Research Unit
Los Angeles California, 90095, United States
Kaiser Permanente Northern California
San Francisco California, 94589, United States
University of Colorado Cancer Center
Aurora Colorado, 80045, United States
Rocky Mountain Cancer Centers
Lakewood Colorado, 80228, United States
Yale University
New Haven Connecticut, 06520, United States
Florida Gynecologic Oncology
Fort Myers Florida, 33905, United States
MD Anderson Cancer Center-Baptist
Jacksonville Florida, 32207, United States
Baptist Health Medical Group Oncology, LLC
Miami Florida, 33176, United States
Florida Hospital
Orlando Florida, 32804, United States
Northside Hospital
Atlanta Georgia, 30342, United States
Augusta University
Augusta Georgia, 30912, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Dr. Sudarshan K. Sharma, Ltd - Gynecologic Oncology
Hinsdale Illinois, 60521, United States
Van le
Springfield Illinois, 62769, United States
Community Health Network
Indianapolis Indiana, 46250, United States
University of Iowa Hospitals
Iowa City Iowa, 52242, United States
University of Kansas Cancer Center
Westwood Kansas, 66205, United States
University of Kentucky
Lexington Kentucky, 40536, United States
Norton Cancer Institute
Louisville Kentucky, 40241, United States
Ochsner Medical Center
New Orleans Louisiana, 70121, United States
Maine Medical Center
Scarborough Maine, 04074, United States
SKCCC at Johns Hopkins
Baltimore Maryland, 21287, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park Minnesota, 55416, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Women's Cancer Center of Nevada
Las Vegas Nevada, 89169, United States
MD Anderson Cancer Center at Cooper
Camden New Jersey, 08103, United States
Summit Medical Group
Florham Park New Jersey, 07932, United States
Women's Cancer Care Associates
Albany New York, 12008, United States
Broome Oncology, LLC
Johnson City New York, 13790, United States
Northwell Health Monter Cancer Center
Lake Success New York, 11042, United States
New York University Medical Center
New York New York, 10016, United States
University of North Carolina
Chapel Hill North Carolina, 27707, United States
University of Cincinnati
Cincinnati Ohio, 45221, United States
Oncology Hematology Care, Inc
Cincinnati Ohio, 45242, United States
Cleveland Clinic
Cleveland Ohio, 44106, United States
The Ohio State University
Columbus Ohio, 43210, United States
MD Anderson Cancer Center - Ohio Health
Columbus Ohio, 44907, United States
University of Oklahoma Health Science Center
Oklahoma City Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute
Tulsa Oklahoma, 74146, United States
Oncology Associates of Oregon, P.C.
Eugene Oregon, 97401, United States
LMG Gynecologic Oncology
Portland Oregon, 97210, United States
Northwest Cancer Specialists, P.C.
Portland Oregon, 97225, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
UPMC Magee-Womens Hospital
Pittsburgh Pennsylvania, 15213, United States
Abington Memorial Hospital
Willow Grove Pennsylvania, 19090, United States
Avera Gynecologic Oncology
Sioux Falls South Dakota, 57105, United States
Texas Oncology - Austin Central
Austin Texas, 78731, United States
Texas Oncology - Bedford
Bedford Texas, 76022, United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas Texas, 75231, United States
Texas Oncology - Fort Worth
Fort Worth Texas, 76104, United States
Memorial Hermann
Houston Texas, 77030, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Texas Oncology - San Antonio Medical Center
San Antonio Texas, 78240, United States
Texas Oncology - The Woodlands, Gynecologic Oncology
The Woodlands Texas, 77380, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Froedtert and Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Newcastle Private Hospital
New Lambton Heights New South Wales, 2145, Australia
Northern Cancer Institute St Leonards
Saint Leonards New South Wales, 2065, Australia
Prince of Wales Hospital
Sydney New South Wales, 2031, Australia
Westmead Hospital
Westmead New South Wales, 2145, Australia
Royal Brisbane and Women's Hospital
Brisbane Queensland, 4020, Australia
Brian Fricker Oncology Centre, Burnside Hospital
Toorak Gardens South Australia, 5065, Australia
Peter MacCallum Cancer Center
Melbourne Victoria, 3000, Australia
St John of God Subiaco Hospital
Subiaco Western Australia, 6005, Australia
UZ Leven
Leuven , 3000, Belgium
Alberta Health Services - University of Calgary
Calgary Alberta, T2N 1, Canada
Alberta Health Services and The University of Alberta
Edmonton Alberta, T6G 2, Canada
BC Cancer - Abbotsford
Abbotsford British Columbia, V2S 0, Canada
BC Cancer - Kelowna
Kelowna British Columbia, V1Y 5, Canada
BC Cancer - Surrey
Surrey British Columbia, V3V 1, Canada
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
Nsha-Qeii Hsc
Halifax Nova Scotia, B3H 2, Canada
Juravinski Cancer Center
Hamilton Ontario, LbV 5, Canada
London Health Sciences Center
London Ontario, N6A 5, Canada
Ottawa Hospital Cancer Centre
Ottawa Ontario, K1H 8, Canada
Centre Hospitalier de l'Université de Montreal
Montréal Quebec, H2X 0, Canada
McGill University Health Center
Montréal Quebec, H4A 3, Canada
Centre Integre Universitaire de sante et de service sociaux de l'Estri-Centre hospitalier univeritaire de Sherbrooke
Sherbrooke Quebec, J1H 5, Canada
Masaryk Memorial Cancer Institute
Brno , 65653, Czechia
Department of Gynecology and Obstetrics, Oncogynecological center U hiversity Hospital Kralovske Vinohrady
Prague , , Czechia
KOC KNTB a.s. Zlfn, Hvalfckovo nabrezf 600, 76001
Zlín , , Czechia
Aalborg University Hospital
Aalborg , 9000, Denmark
Odense University Hospital
Odense , 5000, Denmark
Kuopio University Hospital
Kuopio , 70210, Finland
Klinik für Frauenheilkunde und Geburtshilfe
Dessau , , Germany
Universitaetsklinikum Duesseldorf / Klinik fur Frauenheilkunde & Geburtshilfe
Duesseldorf , , Germany
Universitatsklinikum National Centrum for Tumor Disease (NCT)
Heidelberg , , Germany
Universitätslinikum Mannheim, Frauenklinik
Mannheim , , Germany
Kliniken Suedostbayern AG, Klinikum Traunstein
Traunstein , , Germany
Attikon General University Hospital
Chaidari Athens, 12462, Greece
University Hospital Attikon
Chaidari Athens, 12462, Greece
Alexandra Hospital
Athens , 11528, Greece
General Hospital of Patras
Patra , 26335, Greece
Euromedica General Clinic, B' Oncology Clinic
Thessaloniki , 5465, Greece
Cork University Hospital
Cork , T12 D, Ireland
Bon Secours Hospital
Cork , , Ireland
University Hospital Limerick
Limerick , V94 F, Ireland
University Hospital Waterford
Waterford , X91 E, Ireland
Shaare Zedek Medical Oncology
Jerusalem , , Israel
Meir Medical Center
Kfar Saba , 44281, Israel
Galilee Medical Center
Nahariya , 22100, Israel
Sheba Medical Center
Ramat Gan , 52656, Israel
Ziv Medical Center
Safed , 13100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Centro di Riferimento Oncologico, CRO-IRCCS
Aviano , 33081, Italy
Candiolo Cancer Institute - IRCCS
Candiolo , 10060, Italy
Arnas Garibaldi
Catania , 95122, Italy
University G, D'Annunuzio-Chieti
Chieti , , Italy
IRCCS Instituto Nazionale Tumori
Napoli , 80131, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I
Roma , 00161, Italy
Policlinico Agostino Gemelli
Roma , 00168, Italy
Ospedale S. Giovanni Calibita Fatebenefratelli
Roma , 00186, Italy
Ospedale San Bortolo
Vicenza , 36100, Italy
University of Tsukuba Hospital
Tsukuba Amakubo, , Japan
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan
Kurume University Hospital
Kurume Fukuoka, 830-0, Japan
Yokohama City University Hospital
Yokohama Fukuura, , Japan
Gunma University Hospital
Maebashi Gunma, 371-8, Japan
Gunma Prefectural Cancer Center
Ota-shi Gunma, 373-8, Japan
Hiroshima City Hiroshima Citizens Hospital
Naka Hiroshima, 730-0, Japan
Hyogo Cancer Center
Akashi Hyogo, 673-0, Japan
Iwate Medical University
Morioka Iwate, , Japan
Nippon Medical School Musashikosugi Hospital
Kawasaki-shi Kanagawa, 211-8, Japan
Kanagawa Cancer Center
Yokohama Kanagawa, 241-8, Japan
National Defense Medical College Hospital
Tokorozawa Namiki, , Japan
Osaka International Cancer Institute
Chuo Osaka, 541-8, Japan
Kindai University Hospital
Ōsaka-sayama Osaka, 589-8, Japan
Saitama Medical University International Medical Center
Hidaka Saitama, 350-1, Japan
Keio University Hospital
Shinjuku-Ku Shinanomachi, , Japan
The Cancer Institute Hospital of JFCR
Koto-Ku Tokyo, , Japan
Saitama Cancer Center
Saitama , 362-0, Japan
Kagawa Prefectural Central Hospital
Takamatsu , , Japan
National Cancer Center Hospital
Tokyo , 104-0, Japan
National Cancer Center
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
CHA Bundang Medical Center
Seongnam Gyeonggi-do, 13496, Korea, Republic of
Gachon University Gil Medical Center
Incheon Seoul, 21565, Korea, Republic of
SoonChunHyang Univeristy Cheonan Hosptial
Cheonan , , Korea, Republic of
Korea Cancer Center Hospital
Seoul , 01812, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital,Yonsei University Health System
Seoul , 03722, Korea, Republic of
Konkuk University Medical Center
Seoul , 05030, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Korea University Guro Hospital
Seoul , , Korea, Republic of
Ajou University Hospital
Suwon-si , , Korea, Republic of
Auckland City Hospital
Auckland , 1023, New Zealand
Christchurch Hospital
Christchurch , 8011, New Zealand
Waikato Hospital
Hamilton , 3204, New Zealand
Palmerston North Hospital
Palmerston North , 4442, New Zealand
Tauranga Hospital
Tauranga , 3112, New Zealand
Chair & department of Obsterics, Gynaecology and Oncology (previous site)
Warsaw Kondratowicza, , Poland
Bialostockie Centrum Onkologii Oddzial Onkologii Ginekologicznej
Bialystok , 20-08, Poland
University Hospital of Bialystok
Białystok , , Poland
Szpitale Pomorskie sp zoo
Gdynia , 81-51, Poland
Medical University of Lublin
Lublin , 20-08, Poland
Wielkopolskie Centrum Onkologii
Poznań , 61-86, Poland
Pomeranian Medical University
Szczecin , , Poland
Spitalul Clinic Municipal "Dr. Gavril Curteanu"
Oradea Jud. Bihor, 41046, Romania
S.C. Medisprof S.R.L.
Cluj-Napoca Jud. Cluj, 40064, Romania
Oncopremium Team
Baia Mare , , Romania
SC Quantum Medical Center SRL
Bucuresti , , Romania
Instiute of Oncology - Medical Oncology
Cluj-Napoca , , Romania
Centrul de Oncologie Sf.Nectarie
Craiova , 20034, Romania
S.C Oncolab S.R.L
Craiova , , Romania
Institutul Regional de Oncologie Iasi
Iaşi , 70048, Romania
Spital Municipal Ploiesti
Ploieşti , , Romania
Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" Suceava
Suceava , 72023, Romania
ONCOMED Timisoara
Timişoara , 30023, Romania
Arkhangelsk Clinical Oncological Dispensary
Arkhangel'sk , 16304, Russian Federation
BHI of Omsk Region Clinical Oncology Dispensary
Omsk , 64401, Russian Federation
Orenburg Regional Clinical Oncological Dispensary
Orenburg , , Russian Federation
SBHI Saint Petersburg Research Center specialized types of medical care (Oncology)
Pesochnyy , 19775, Russian Federation
SBHI SR Pyatigorsk Interdistrict Oncology Dispensary
Pyatigorsk , 35750, Russian Federation
Limited Liability Company MedPomosch
Saint Petersburg , 19435, Russian Federation
FSBEI HE I.P. Pavlov SPbSMU MoH Russia
Saint Petersburg , 19702, Russian Federation
Saint-Petersburg State Budget Institution of Healthcare City Clinical Oncology Dispensary
Saint Petersburg , 19825, Russian Federation
1st Medical University
Saint Petersburg , , Russian Federation
Federa; State Budgetary Educational Institution of Higher Education National Research Ogarev Mordovia State University
Saransk , 43003, Russian Federation
State Medical Institution "Oncology Center #2" under the Krasnodar Region Healthcare Department
Sotchi , 35405, Russian Federation
National University Hospital
Singapore , 11908, Singapore
National Cancer Center Singapore
Singapore , , Singapore
Vall d'Hebron Institute of Oncology
Barcelona , 08035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona , 08041, Spain
Hospital Universitario Basurto
Bilbao , 48013, Spain
Consorcio Hospitalario Provincial Castellon
Castillón , 12002, Spain
Hospital Virgen de la Arrixaca
El Palmar , 30120, Spain
Hospital de Jerez
Jerez de la Frontera , 11407, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid , 28222, Spain
Hospital Universitario Central de Asturias
Oviedo , 33011, Spain
Hospital Son Llatzer
Palma De Mallorca , 07198, Spain
Hospital Nuestra Señora de Valme
Sevilla , 41014, Spain
Onkologiska Kliniken
Linköping , , Sweden
Onkologiska Kliniken
Lund , , Sweden
Karolinska Universitetssjukhuset
Stockholm , , Sweden
Hualien Tzu Chi Hospital
Hualien City , , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung , 81362, Taiwan
Far Eastern Memorial Hospital
New Taipei City , 22060, Taiwan
Taichung Veterans General Hospital
Taichung , 40705, Taiwan
China Medical University Hospital
Taichung , , Taiwan
Chi Mei Hospital, Liouying (CMHLY)
Tainan , , Taiwan
Chi Mei Medical Center (CMMC)
Tainan , , Taiwan
National Taiwan University Hospital
Taipei , 10048, Taiwan
Mackay Memorial Hospital
Taipei , 10449, Taiwan
Taipei Veterans General Hospital
Taipei , 11217, Taiwan
Tri-Service General Hospital
Taipei , 11490, Taiwan
Taipei Medical Univeristy Hopsital
Taipei , , Taiwan
Chang Gung Medical Foundation- Linkou Branch
Taoyuan , 33305, Taiwan
Dr. Abdurrahman Yurtaslan Ankara Women's Health Education and Research Hospital
Ankara , , Turkey
Istanbul University-cerrahpasa, Cerrahpasa School of Medicine
Istanbul , , Turkey
Koc University School of Medicine, Koc University Hospital
Istanbul , , Turkey
Celal Bayar University Faculty of Medicine
Manisa , 45030, Turkey
Baskent University Hospital
Yuregir , , Turkey
East Kent Hospitals University NHS Foundation trust Medical Oncology
Canterbury Kent, CT1 3, United Kingdom
Northampton General Hospital
Cliftonville Northampton, NN1 5, United Kingdom
Royal Sussex County Hospital
Brighton , BN2 3, United Kingdom
Bristol Cancer Institute Medical Oncology
Bristol , BS2 8, United Kingdom
Addenbrookes Hospital
Cambridge , CB2 0, United Kingdom
Western General Hospital
Edinburgh , EH4 2, United Kingdom
University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster , LA1 4, United Kingdom
St. James University Hospital
Leeds , LS9 7, United Kingdom
Barts and the London NHS Trust
London , EC1A , United Kingdom
University of College London Hospital
London , NW1 2, United Kingdom
Guy's & St Thomas' NHS Foundation Trust (Guy's Cancer Centre)
London , SE1 9, United Kingdom
The Royal Marsden NHS Foundation Trust
London , SW3 6, United Kingdom
Imperial College London
London , W12 0, United Kingdom
The James Cook University Hospital
Middlesbrough , TS4 3, United Kingdom
Poole Hospital NHS Foundation Trust
Poole , BH15 , United Kingdom
South West Wales Cancer Centre - Singleton Hospital
Swansea , SA2 8, United Kingdom
Musgrove Park Hospital
Taunton , TA1 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

1000

Study ID:

NCT03522246

Recruitment Status:

Active, not recruiting

Sponsor:


pharmaand GmbH

How clear is this clinincal trial information?

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