A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
- Conditions
- Partial ResponseNewly DiagnosedComplete ResponsePrimary PeritonealEpithelial Ovarian CancerFallopian Tube CancerFIGO Stage III-IV
- Interventions
- Registration Number
- NCT03522246
- Lead Sponsor
- pharmaand GmbH
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 1097
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Rucaparib Oral rucaparib + intravenous (IV) nivolumab Arm A Nivolumab Oral rucaparib + intravenous (IV) nivolumab Arm B Rucaparib Oral rucaparib + IV placebo Arm B Placebo IV Infusion Oral rucaparib + IV placebo Arm C Nivolumab Oral placebo + IV nivolumab Arm C Placebo Oral Tablet Oral placebo + IV nivolumab Arm D Placebo Oral Tablet Oral placebo + IV placebo Arm D Placebo IV Infusion Oral placebo + IV placebo Japanese Open-label Safety Cohort Rucaparib Oral rucaparib + IV nivolumab Japanese Open-label Safety Cohort Nivolumab Oral rucaparib + IV nivolumab
- Primary Outcome Measures
Name Time Method Investigator assessed Progression-free survival (PFS) From randomization until disease progression (up to approximately 7 years)
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) From enrollment to primary study completion of study (up to approximately 10 years) Number of participants with treatment-emergent Adverse Events (AEs) as assessed by CTCAE v4 (or higher) as a measure of safety and tolerability Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years) Duration of response (DOR) For patients with measurable disease, every ~12 weeks after the start of combination treatment for ~3 years, then every ~24 weeks thereafter until disease progression. Study data collection expected to last for ~7 years Number of participants with laboratory abnormalities as a measure of safety and tolerability Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years) Objective response rate (ORR) For patients with measurable disease, every ~12 weeks after the start of combination treatment for ~3 years, then every ~24 weeks thereafter until disease progression. Study data collection expected to last for ~7 years Blinded independent central review (BICR) PFS Every ~12 weeks after the start of combination treatment for ~3 years, then every ~24 weeks thereafter until disease progression. Study data collection expected to last for ~7 years Number of participants with serious AEs as a measure of safety and tolerability Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years)
Trial Locations
- Locations (237)
Arizona Oncology Associates, PC - HAL
🇺🇸Phoenix, Arizona, United States
Arizona Oncology Associates, PC - HOPE
🇺🇸Tucson, Arizona, United States
The University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
John Muir Clinical Research Center
🇺🇸Concord, California, United States
UCLA Women's Health Clinical Research Unit
🇺🇸Los Angeles, California, United States
Kaiser Permanente Northern California
🇺🇸San Francisco, California, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Rocky Mountain Cancer Centers
🇺🇸Lakewood, Colorado, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Florida Gynecologic Oncology
🇺🇸Fort Myers, Florida, United States
MD Anderson Cancer Center-Baptist
🇺🇸Jacksonville, Florida, United States
Baptist Health Medical Group Oncology, LLC
🇺🇸Miami, Florida, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Dr. Sudarshan K. Sharma, Ltd - Gynecologic Oncology
🇺🇸Hinsdale, Illinois, United States
Van le
🇺🇸Springfield, Illinois, United States
Community Health Network
🇺🇸Indianapolis, Indiana, United States
University of Iowa Hospitals
🇺🇸Iowa City, Iowa, United States
University of Kansas Cancer Center
🇺🇸Westwood, Kansas, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Maine Medical Center
🇺🇸Scarborough, Maine, United States
SKCCC at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Metro Minnesota Community Oncology Research Consortium
🇺🇸Saint Louis Park, Minnesota, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Women's Cancer Center of Nevada
🇺🇸Las Vegas, Nevada, United States
MD Anderson Cancer Center at Cooper
🇺🇸Camden, New Jersey, United States
Summit Medical Group
🇺🇸Florham Park, New Jersey, United States
Women's Cancer Care Associates
🇺🇸Albany, New York, United States
Broome Oncology, LLC
🇺🇸Johnson City, New York, United States
Northwell Health Monter Cancer Center
🇺🇸Lake Success, New York, United States
New York University Medical Center
🇺🇸New York, New York, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Oncology Hematology Care, Inc
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
MD Anderson Cancer Center - Ohio Health
🇺🇸Columbus, Ohio, United States
University of Oklahoma Health Science Center
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute
🇺🇸Tulsa, Oklahoma, United States
Oncology Associates of Oregon, P.C.
🇺🇸Eugene, Oregon, United States
LMG Gynecologic Oncology
🇺🇸Portland, Oregon, United States
Northwest Cancer Specialists, P.C.
🇺🇸Portland, Oregon, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
UPMC Magee-Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Abington Memorial Hospital
🇺🇸Willow Grove, Pennsylvania, United States
Avera Gynecologic Oncology
🇺🇸Sioux Falls, South Dakota, United States
Texas Oncology - Austin Central
🇺🇸Austin, Texas, United States
Texas Oncology - Bedford
🇺🇸Bedford, Texas, United States
Texas Oncology - Dallas Presbyterian Hospital
🇺🇸Dallas, Texas, United States
Texas Oncology - Fort Worth
🇺🇸Fort Worth, Texas, United States
Memorial Hermann
🇺🇸Houston, Texas, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Texas Oncology - San Antonio Medical Center
🇺🇸San Antonio, Texas, United States
Texas Oncology - The Woodlands, Gynecologic Oncology
🇺🇸The Woodlands, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Froedtert and Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Newcastle Private Hospital
🇦🇺New Lambton Heights, New South Wales, Australia
Northern Cancer Institute St Leonards
🇦🇺Saint Leonards, New South Wales, Australia
Prince of Wales Hospital
🇦🇺Sydney, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Brian Fricker Oncology Centre, Burnside Hospital
🇦🇺Toorak Gardens, South Australia, Australia
Peter MacCallum Cancer Center
🇦🇺Melbourne, Victoria, Australia
St John of God Subiaco Hospital
🇦🇺Subiaco, Western Australia, Australia
UZ Leven
🇧🇪Leuven, Belgium
Alberta Health Services - University of Calgary
🇨🇦Calgary, Alberta, Canada
Alberta Health Services and The University of Alberta
🇨🇦Edmonton, Alberta, Canada
BC Cancer - Abbotsford
🇨🇦Abbotsford, British Columbia, Canada
BC Cancer - Kelowna
🇨🇦Kelowna, British Columbia, Canada
BC Cancer - Surrey
🇨🇦Surrey, British Columbia, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Nsha-Qeii Hsc
🇨🇦Halifax, Nova Scotia, Canada
Juravinski Cancer Center
🇨🇦Hamilton, Ontario, Canada
London Health Sciences Center
🇨🇦London, Ontario, Canada
Ottawa Hospital Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Centre Hospitalier de l'Université de Montreal
🇨🇦Montréal, Quebec, Canada
McGill University Health Center
🇨🇦Montréal, Quebec, Canada
Centre Integre Universitaire de sante et de service sociaux de l'Estri-Centre hospitalier univeritaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Masaryk Memorial Cancer Institute
🇨🇿Brno, 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, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
Kuopio University Hospital
🇫🇮Kuopio, 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, Greece
University Hospital Attikon
🇬🇷Chaidari, Athens, Greece
Alexandra Hospital
🇬🇷Athens, Greece
General Hospital of Patras
🇬🇷Patra, Greece
Euromedica General Clinic, B' Oncology Clinic
🇬🇷Thessaloniki, Greece
Cork University Hospital
🇮🇪Cork, Ireland
Bon Secours Hospital
🇮🇪Cork, Ireland
University Hospital Limerick
🇮🇪Limerick, Ireland
University Hospital Waterford
🇮🇪Waterford, Ireland
Shaare Zedek Medical Oncology
🇮🇱Jerusalem, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
Galilee Medical Center
🇮🇱Nahariya, Israel
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Ziv Medical Center
🇮🇱Safed, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Centro di Riferimento Oncologico, CRO-IRCCS
🇮🇹Aviano, Italy
Candiolo Cancer Institute - IRCCS
🇮🇹Candiolo, Italy
Arnas Garibaldi
🇮🇹Catania, Italy
University G, D'Annunuzio-Chieti
🇮🇹Chieti, Italy
IRCCS Instituto Nazionale Tumori
🇮🇹Napoli, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I
🇮🇹Roma, Italy
Policlinico Agostino Gemelli
🇮🇹Roma, Italy
Ospedale S. Giovanni Calibita Fatebenefratelli
🇮🇹Roma, Italy
Ospedale San Bortolo
🇮🇹Vicenza, Italy
University of Tsukuba Hospital
🇯🇵Tsukuba, Amakubo, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
Yokohama City University Hospital
🇯🇵Yokohama, Fukuura, Japan
Gunma University Hospital
🇯🇵Maebashi, Gunma, Japan
Gunma Prefectural Cancer Center
🇯🇵Ota-shi, Gunma, Japan
Hiroshima City Hiroshima Citizens Hospital
🇯🇵Naka, Hiroshima, Japan
Hyogo Cancer Center
🇯🇵Akashi, Hyogo, Japan
Iwate Medical University
🇯🇵Morioka, Iwate, Japan
Nippon Medical School Musashikosugi Hospital
🇯🇵Kawasaki-shi, Kanagawa, Japan
Kanagawa Cancer Center
🇯🇵Yokohama, Kanagawa, Japan
National Defense Medical College Hospital
🇯🇵Tokorozawa, Namiki, Japan
Osaka International Cancer Institute
🇯🇵Chuo, Osaka, Japan
Kindai University Hospital
🇯🇵Ōsaka-sayama, Osaka, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka, Saitama, Japan
Keio University Hospital
🇯🇵Shinjuku-Ku, Shinanomachi, Japan
The Cancer Institute Hospital of JFCR
🇯🇵Koto-Ku, Tokyo, Japan
Saitama Cancer Center
🇯🇵Saitama, Japan
Kagawa Prefectural Central Hospital
🇯🇵Takamatsu, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Japan
National Cancer Center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
CHA Bundang Medical Center
🇰🇷Seongnam, Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Seoul, Korea, Republic of
SoonChunHyang University Cheonan Hospital
🇰🇷Cheonan, Korea, Republic of
Korea Cancer Center Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon-si, Korea, Republic of
Auckland City Hospital
🇳🇿Auckland, New Zealand
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Waikato Hospital
🇳🇿Hamilton, New Zealand
Palmerston North Hospital
🇳🇿Palmerston North, New Zealand
Tauranga Hospital
🇳🇿Tauranga, New Zealand
Chair & department of Obsterics, Gynaecology and Oncology (previous site)
🇵🇱Warsaw, Kondratowicza, Poland
Bialostockie Centrum Onkologii Oddzial Onkologii Ginekologicznej
🇵🇱Bialystok, Poland
University Hospital of Bialystok
🇵🇱Białystok, Poland
Szpitale Pomorskie sp zoo
🇵🇱Gdynia, Poland
Medical University of Lublin
🇵🇱Lublin, Poland
Wielkopolskie Centrum Onkologii
🇵🇱Poznań, Poland
Pomeranian Medical University
🇵🇱Szczecin, Poland
Spitalul Clinic Municipal "Dr. Gavril Curteanu"
🇷🇴Oradea, Jud. Bihor, Romania
S.C. Medisprof S.R.L.
🇷🇴Cluj-Napoca, Jud. Cluj, 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, Romania
S.C Oncolab S.R.L
🇷🇴Craiova, Romania
Institutul Regional de Oncologie Iasi
🇷🇴Iaşi, Romania
Spital Municipal Ploiesti
🇷🇴Ploieşti, Romania
Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" Suceava
🇷🇴Suceava, Romania
ONCOMED Timisoara
🇷🇴Timişoara, Romania
Arkhangelsk Clinical Oncological Dispensary
🇷🇺Arkhangel'sk, Russian Federation
BHI of Omsk Region Clinical Oncology Dispensary
🇷🇺Omsk, Russian Federation
Orenburg Regional Clinical Oncological Dispensary
🇷🇺Orenburg, Russian Federation
SBHI Saint Petersburg Research Center specialized types of medical care (Oncology)
🇷🇺Pesochnyy, Russian Federation
SBHI SR Pyatigorsk Interdistrict Oncology Dispensary
🇷🇺Pyatigorsk, Russian Federation
Limited Liability Company MedPomosch
🇷🇺Saint Petersburg, Russian Federation
FSBEI HE I.P. Pavlov SPbSMU MoH Russia
🇷🇺Saint Petersburg, Russian Federation
Saint-Petersburg State Budget Institution of Healthcare City Clinical Oncology Dispensary
🇷🇺Saint Petersburg, Russian Federation
1st Medical University
🇷🇺Saint Petersburg, Russian Federation
Federa; State Budgetary Educational Institution of Higher Education National Research Ogarev Mordovia State University
🇷🇺Saransk, Russian Federation
State Medical Institution "Oncology Center #2" under the Krasnodar Region Healthcare Department
🇷🇺Sotchi, Russian Federation
National University Hospital
🇸🇬Singapore, Singapore
National Cancer Center Singapore
🇸🇬Singapore, Singapore
Vall d'Hebron Institute of Oncology
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario Basurto
🇪🇸Bilbao, Spain
Consorcio Hospitalario Provincial Castellon
🇪🇸Castillón, Spain
Hospital Virgen de la Arrixaca
🇪🇸El Palmar, Spain
Hospital de Jerez
🇪🇸Jerez de la Frontera, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
🇪🇸Madrid, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital Son Llatzer
🇪🇸Palma De Mallorca, Spain
Hospital Nuestra Señora de Valme
🇪🇸Sevilla, Spain
Onkologiska Kliniken
🇸🇪Lund, Sweden
Karolinska Universitetssjukhuset
🇸🇪Stockholm, Sweden
Hualien Tzu Chi Hospital
🇨🇳Hualien City, Taiwan
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
Far Eastern Memorial Hospital
🇨🇳New Taipei City, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, 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, Taiwan
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
Taipei Medical University Hospital
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation- Linkou Branch
🇨🇳Taoyuan, 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, Turkey
Baskent University Hospital
🇹🇷Yuregir, Turkey
East Kent Hospitals University NHS Foundation trust Medical Oncology
🇬🇧Canterbury, Kent, United Kingdom
Northampton General Hospital
🇬🇧Cliftonville, Northampton, United Kingdom
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Bristol Cancer Institute Medical Oncology
🇬🇧Bristol, United Kingdom
Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom
Western General Hospital
🇬🇧Edinburgh, United Kingdom
University Hospitals of Morecambe Bay NHS Foundation Trust
🇬🇧Lancaster, United Kingdom
St. James University Hospital
🇬🇧Leeds, United Kingdom
Barts and the London NHS Trust
🇬🇧London, United Kingdom
University of College London Hospital
🇬🇧London, United Kingdom
Guy's & St Thomas' NHS Foundation Trust (Guy's Cancer Centre)
🇬🇧London, United Kingdom
The Royal Marsden NHS Foundation Trust
🇬🇧London, United Kingdom
Imperial College London
🇬🇧London, United Kingdom
The James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
Poole Hospital NHS Foundation Trust
🇬🇧Poole, United Kingdom
South West Wales Cancer Centre - Singleton Hospital
🇬🇧Swansea, United Kingdom
Musgrove Park Hospital
🇬🇧Taunton, United Kingdom