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A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy (ATHENA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03522246
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : August 2, 2019
Sponsor:
Collaborators:
Bristol-Myers Squibb
Gynecologic Oncology Group
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Foundation Medicine
Information provided by (Responsible Party):
Clovis Oncology, Inc.

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.

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Primary Peritoneal Fallopian Tube Cancer Newly Diagnosed FIGO Stage III-IV Partial Response Complete Response Drug: Rucaparib Drug: Nivolumab Drug: Placebo Oral Tablet Drug: Placebo IV Infusion Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1012 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-Blind
Primary Purpose: Treatment
Official Title: ATHENA (A Multicenter, Randomized, Double-Blind, Placebo- Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy)
Actual Study Start Date : May 14, 2018
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : December 30, 2030


Arm Intervention/treatment
Experimental: Arm A
oral rucaparib + intravenous (IV) nivolumab
Drug: Rucaparib
Oral rucaparib will be administered twice daily
Other Names:
  • Rubraca
  • CO-338

Drug: Nivolumab
IV nivolumab will be administered once every 4 weeks
Other Names:
  • Opdivo
  • BMS-936558

Experimental: Arm B
oral rucaparib+IV placebo
Drug: Rucaparib
Oral rucaparib will be administered twice daily
Other Names:
  • Rubraca
  • CO-338

Drug: Placebo IV Infusion
IV placebo will be administered once every 4 weeks

Experimental: Arm C
oral placebo+ IV nivolumab
Drug: Nivolumab
IV nivolumab will be administered once every 4 weeks
Other Names:
  • Opdivo
  • BMS-936558

Drug: Placebo Oral Tablet
Placebo tablets will be administered twice daily

Placebo Comparator: Arm D
Oral placebo + IV placebo
Drug: Placebo Oral Tablet
Placebo tablets will be administered twice daily

Drug: Placebo IV Infusion
IV placebo will be administered once every 4 weeks




Primary Outcome Measures :
  1. Investigator assessed Progression-free survival (PFS) [ Time Frame: From randomization until disease progression (up to approximately 7 years) ]

Secondary Outcome Measures :
  1. Blinded independent central review (BICR) PFS [ Time Frame: 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 ]
  2. Overall Survival (OS) [ Time Frame: From enrollment to primary study completion of study (up to approximately 10 years) ]
  3. Objective response rate (ORR) [ Time Frame: 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 ]
  4. Duration of response (DOR) [ Time Frame: 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 ]
  5. Number of participants with treatment-emergent Adverse Events (AEs) as assessed by CTCAE v4 (or higher) as a measure of safety and tolerability [ Time Frame: Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years) ]
  6. Number of participants with serious AEs as a measure of safety and tolerability [ Time Frame: Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years) ]
  7. Number of participants with laboratory abnormalities as a measure of safety and tolerability [ Time Frame: Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522246


Contacts
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Contact: Clovis Oncology Clinical Trial Information 1-855-262-3040 (USA) clovistrials@emergingmed.com
Contact: Clovis Oncology Clinical Trial infomration +1-303-625-5160 (ex-USA) clovistrials@emergingmed.com

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Locations
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United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Arizona Oncology Associates, PC - HAL Recruiting
Phoenix, Arizona, United States, 85016
Arizona Oncology Associates, PC - HOPE Recruiting
Tucson, Arizona, United States, 85711
The University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
United States, California
John Muir Clinical Research Center Recruiting
Concord, California, United States, 94520
UCSD Moores Cancer Center Recruiting
La Jolla, California, United States, 92037-0845
UCSF Medical Center - Investigational Drugs Pharmacy Recruiting
San Francisco, California, United States, 94158
Kaiser Permanente Northern California Recruiting
San Francisco, California, United States, 94589
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers Recruiting
Lakewood, Colorado, United States, 80228
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
Florida Gynecologic Oncology Recruiting
Fort Myers, Florida, United States, 33905
MD Anderson Cancer Center-Baptist Recruiting
Jacksonville, Florida, United States, 32207
Baptist Health Medical Group Oncology, LLC Recruiting
Miami, Florida, United States, 33176
Florida Hospital Recruiting
Orlando, Florida, United States, 32804
United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Augusta University Recruiting
Augusta, Georgia, United States, 30912
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Dr. Sudarshan K. Sharma, Ltd - Gynecologic Oncology Recruiting
Hinsdale, Illinois, United States, 60521
Ferrell-Duncan Clinic Recruiting
Springfield, Illinois, United States, 65807
United States, Indiana
Community Health Network Recruiting
Indianapolis, Indiana, United States, 46250
United States, Iowa
University of Iowa Hospitals Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Cancer Center Recruiting
Westwood, Kansas, United States, 66205
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40241
United States, Louisiana
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
United States, Maine
Maine Medical Center Recruiting
Scarborough, Maine, United States, 04074
United States, Maryland
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
United States, Minnesota
Metro Minnesota Community Oncology Research Consortium Recruiting
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Mercy Springfield Recruiting
Springfield, Missouri, United States, 65804
United States, Nevada
Women's Cancer Center of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
United States, New Jersey
MD Anderson Cancer Center at Cooper Recruiting
Camden, New Jersey, United States, 08103
Summit Medical Group Recruiting
Florham Park, New Jersey, United States, 07932
United States, New York
Women's Cancer Care Associates Recruiting
Albany, New York, United States, 12008
Broome Oncology, LLC Recruiting
Johnson City, New York, United States, 13790
Northwell Health Monter Cancer Center Recruiting
Lake Success, New York, United States, 11042
New York University Medical Center Recruiting
New York, New York, United States, 10016
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27707
Duke Unversity, Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Oncology Hematology Care, Inc Recruiting
Cincinnati, Ohio, United States, 45242
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44106
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Columbus NCORP Recruiting
Columbus, Ohio, United States, 43215
United States, Oklahoma
University of Oklahoma Health Science Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Oklahoma Cancer Specialists and Research Institute Recruiting
Tulsa, Oklahoma, United States, 74146
United States, Oregon
Willamette Valley Cancer Institute and Research Center Recruiting
Eugene, Oregon, United States, 97401
LMG Gynecologic Oncology Recruiting
Portland, Oregon, United States, 97210
Northwest Cancer Specialists, P.C. Recruiting
Portland, Oregon, United States, 97225
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
UPMC Magee-Womens Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Abington Memorial Hospital Recruiting
Willow Grove, Pennsylvania, United States, 19090
United States, South Dakota
Avera Gynecologic Oncology Recruiting
Sioux Falls, South Dakota, United States, 57105
United States, Texas
Texas Oncology - Austin Central Recruiting
Austin, Texas, United States, 78731
Texas Oncology - Bedford Recruiting
Bedford, Texas, United States, 76022
Texas Oncology - Dallas Presbyterian Hospital Recruiting
Dallas, Texas, United States, 75231
Texas Oncology - Fort Worth Recruiting
Fort Worth, Texas, United States, 76104
Memorial Hermann Recruiting
Houston, Texas, United States, 77030
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Texas Oncology - San Antonio Medical Center Recruiting
San Antonio, Texas, United States, 78240
Texas Oncology - The Woodlands, Gynecologic Oncology Recruiting
The Woodlands, Texas, United States, 77380
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
United States, Virginia
Virginia Oncology Associates Recruiting
Norfolk, Virginia, United States, 23502
United States, Wisconsin
Froedtert and Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Australia, AU
Border Medical Oncology Recruiting
Albury, AU, Australia, 2640
Australia, New South Wales
Newcastle Private Hospital Recruiting
New Lambton Heights, New South Wales, Australia, 2145
Northern Cancer Institute St Leonards Recruiting
Saint Leonards, New South Wales, Australia, 2065
Prince of Wales Hospital Recruiting
Sydney, New South Wales, Australia, 2031
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Brisbane, Queensland, Australia, 4020
Australia, South Australia
Brian Fricker Oncology Centre, Burnside Hospital Recruiting
Toorak Gardens, South Australia, Australia, 5065
Australia, Victoria
Peter MacCallum Cancer Center Recruiting
Melbourne, Victoria, Australia, 3000
Australia, Western Australia
St John of God Subiaco Hospital Recruiting
Subiaco, Western Australia, Australia, 6005
Belgium
UZ Leven Recruiting
Leuven, Belgium, 3000
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BC Cancer - Abbotsford Recruiting
Abbotsford, British Columbia, Canada, V2S 0C2
BC Cancer - Kelowna Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
BC Cancer - Surrey Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
Nsha-Qeii Hsc Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Juravinski Cancer Center Recruiting
Hamilton, Ontario, Canada, LbV 5C2
London Health Sciences Center Recruiting
London, Ontario, Canada, N6A 5W9
Princess Margaret Cancer Center Recruiting
Toronto, Ontario, Canada, M5G
Canada, Quebec
Centre Hospitalier de l'Université de Montreal Recruiting
Montréal, Quebec, Canada, H2X 0C2
McGill University Health Center Recruiting
Montréal, Quebec, Canada, H4A 3J1
Centre Integre Universitaire de sante et de service sociaux de l'Estri-Centre hospitalier univeritaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Odense University Hospital Recruiting
Odense, Denmark, 5000
Finland
Kuopio University Hospital Recruiting
Kuopio, Finland, 70210
Greece
Attikon General University Hospital Recruiting
Chaidari, Athens, Greece, 12462
University Hospital Attikon Recruiting
Chaidari, Athens, Greece, 12462
Alexandra Hospital Recruiting
Athens, Greece, 11528
General Hospital of Patras Recruiting
Patra, Greece, 26335
Euromedica General Clinic, B' Oncology Clinic Recruiting
Thessaloniki, Greece, 5465
Ireland
Cork University Hospital Recruiting
Cork, Ireland, T12 DC4A
St James's Hospital Recruiting
Dublin, Ireland, D03 VX82
University Hospital Limerick Recruiting
Limerick, Ireland, V94 F858
University Hospital Waterford Recruiting
Waterford, Ireland, X91 ER8E
Israel
Hillel Yaffe MC Recruiting
Hadera, Israel, 38100
Meir Medical Center Recruiting
Kfar Saba, Israel, 4428164
Galilee Medical Center Recruiting
Nahariya, Israel, 2210001
Sheba Medical Center Recruiting
Ramat Gan, Israel, 5265601
Ziv Medical Center Recruiting
Safed, Israel, 13100
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 6423906
Italy
Centro di Riferimento Oncologico, CRO-IRCCS Recruiting
Aviano, Italy, 33081
Candiolo Cancer Institute - IRCCS Recruiting
Candiolo, Italy, 10060
Arnas Garibaldi Recruiting
Catania, Italy, 95122
Universita Clegie Studi Magna Graecia di Catazaro Recruiting
Catanzaro, Italy, 88100
IRCCS Instituto Nazionale Tumori Recruiting
Napoli, Italy, 80131
AUSL/IRCCS di Reggio Emilia Recruiting
Reggio Emilia, Italy, 42123
Azienda Ospedaliera Universitaria Policlinico Umberto I Recruiting
Roma, Italy, 00161
Policlinico Agostino Gemelli Recruiting
Roma, Italy, 00168
Ospedale S. Giovanni Calibita Fatebenefratelli Recruiting
Roma, Italy, 00186
Ospedale San Bortolo Recruiting
Vicenza, Italy, 36100
Japan
National Cancer Center Hospital East Recruiting
Kashiwa, Chiba, Japan, 277-8577
Nippon Medical School Musashikosugi Hospital Recruiting
Kawasaki-shi, Kanagawa, Japan, 211-8533
Saitama Medical University International Medical Center Recruiting
Hidaka, Saitama, Japan, 350-1298
National Cancer Center Hospital Recruiting
Tokyo, Japan, 104-0045
Korea, Republic of
National Cancer Center Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
CHA Bundang Medical Center Recruiting
Seongnam, Gyeonggi-do, Korea, Republic of, 13496
Gachon University Gil Medical Center Recruiting
Incheon, Seoul, Korea, Republic of, 21565
Korea Cancer Center Hospital Recruiting
Seoul, Korea, Republic of, 01812
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital,Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Konkuk University Medical Center Recruiting
Seoul, Korea, Republic of, 05030
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
New Zealand
Auckland City Hospital Recruiting
Auckland, New Zealand, 1023
Christchurch Hospital Recruiting
Christchurch, New Zealand, 8011
Waikato Hospital Recruiting
Hamilton, New Zealand, 3204
Palmerston North Hospital Recruiting
Palmerston North, New Zealand, 4442
Tauranga Hospital Recruiting
Tauranga, New Zealand, 3112
Poland
Bialostockie Centrum Onkologii Oddzial Onkologii Ginekologicznej Recruiting
Bialystok, Poland, 20-081
Uniwersytecki Szpital Kliniczny Recruiting
Białystok, Poland, 15276
Szpitale Pomorskie sp zoo Recruiting
Gdynia, Poland, 81-519
Swietokrzyskie Centrum ONkologii Recruiting
Kielce, Poland, 25-734
Medical University of Lublin Recruiting
Lublin, Poland, 20-081
Wielkopolskie Centrum Onkologii Recruiting
Poznań, Poland, 61-866
Samodzielny Publiczny Szpital Kliniczny Nr 2 Pomorskiego Uniwersytetu Medycznego w Szczecinie Recruiting
Szczecin, Poland, 70-111
Szpital Magodent Recruiting
Warszawa, Poland, 01-748
Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Recruiting
Cluj-Napoca, Cluj, Romania, 400015
Spitalul Clinic Municipal "Dr. Gavril Curteanu" Recruiting
Oradea, Jud. Bihor, Romania, 410469
S.C. Medisprof S.R.L. Recruiting
Cluj-Napoca, Jud. Cluj, Romania, 400641
Teo Health SA - Spitalul Sf-Constantin Recruiting
Braşov, Romania, 500091
Institutul Oncologic, Prof. Dr. Alexandru Trestioreanu Recruiting
Bucharest, Romania, 022328
Centrul de Oncologie Sf.Nectarie Recruiting
Craiova, Romania, 200347
Institutul Regional de Oncologie Iasi Recruiting
Iaşi, Romania, 700489
Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" Suceava Recruiting
Suceava, Romania, 720237
ONCOMED Timisoara Recruiting
Timişoara, Romania, 300239
Russian Federation
Arkhangelsk Clinical Oncological Dispensary Recruiting
Arkhangel'sk, Russian Federation, 163045
Kursk Regional Clinical Oncology Dispensary Recruiting
Kursk, Russian Federation, 305524
BHI of Omsk Region Clinical Oncology Dispensary Recruiting
Omsk, Russian Federation, 644013
SBHI Saint Petersburg Research Center specialized types of medical care (Oncology) Recruiting
Pesochnyy, Russian Federation, 197758
SBHI SR Pyatigorsk Interdistrict Oncology Dispensary Recruiting
Pyatigorsk, Russian Federation, 357502
Limited Liability Company MedPomosch Recruiting
Saint Petersburg, Russian Federation, 194356
FSBEI HE I.P. Pavlov SPbSMU MoH Russia Recruiting
Saint Petersburg, Russian Federation, 197022
Saint-Petersburg State Budget Institution of Healthcare City Clinical Oncology Dispensary Recruiting
Saint Petersburg, Russian Federation, 198255
Federa; State Budgetary Educational Institution of Higher Education National Research Ogarev Mordovia State University Recruiting
Saransk, Russian Federation, 430032
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119082
Spain
Vall d'Hebron Institute of Oncology Recruiting
Barcelona, Spain, 08035
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08041
Hospital Universitario Basurto Recruiting
Bilbao, Spain, 48013
Consorcio Hospitalario Provincial Castellon Recruiting
Castillón, Spain, 12002
Hospital Virgen de la Arrixaca Recruiting
El Palmar, Spain, 30120
Hospital de Jerez Recruiting
Jerez de la Frontera, Spain, 11407
Hospital Universitario Puerta de Hierro - Majadahonda Recruiting
Madrid, Spain, 28222
Hospital Universitario Central de Asturias Recruiting
Oviedo, Spain, 33011
Hospital Son Llatzer Recruiting
Palma De Mallorca, Spain, 07198
H. Universitary Marques Valdecilla Recruiting
Santander, Spain, 39008
Hospital Nuestra Señora de Valme Recruiting
Sevilla, Spain, 41014
Taiwan
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 81362
Far Eastern Memorial Hospital Recruiting
New Taipei City, Taiwan, 22060
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10048
Mackay Memorial Hospital Recruiting
Taipei, Taiwan, 10449
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Tri-Service General Hospital Recruiting
Taipei, Taiwan, 11490
Chang Gung Medical Foundation- Linkou Branch Recruiting
Taoyuan, Taiwan, 33305
Turkey
Gazi University Faculty of Medicine Recruiting
Ankara, Turkey, 06560
Celal Bayar University Faculty of Medicine Recruiting
Manisa, Turkey, 45030
United Kingdom
Southampton General Hospital Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
East Kent Hospitals University NHS Foundation trust Medical Oncology Recruiting
Canterbury, Kent, United Kingdom, CT1 3NG
St George's University Hospitals NHS Foundation Trust Recruiting
Tooting, London, United Kingdom, SW17 0QT
Mount Vernon Cancer Centre Recruiting
Northwood, Middlesex, United Kingdom, HA6 2RN
Northampton General Hospital Recruiting
Cliftonville, Northampton, United Kingdom, NN1 5BD
The Clatterbridge Cancer Centre Recruiting
Bebington, Wirral, United Kingdom, CH63 4JY
Queen Elizabeth University Hospital Recruiting
Birmingham, United Kingdom, B30 3HG
Royal Sussex County Hospital Recruiting
Brighton, United Kingdom, BN2 3EH
Bristol Cancer Institute Medical Oncology Recruiting
Bristol, United Kingdom, BS2 8HW
Addenbrookes Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
Ninewells Hospital and Medical School Recruiting
Dundee, United Kingdom, DD1 9SY
Western General Hospital Recruiting
Edinburgh, United Kingdom, EH4 2XU
University Hospitals of Morecambe Bay NHS Foundation Trust Recruiting
Lancaster, United Kingdom, LA1 4RP
St. James University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
Barts and the London NHS Trust Recruiting
London, United Kingdom, EC1A 7BE
University of College London Hospital Recruiting
London, United Kingdom, NW1 2PG
Guy's & St Thomas' NHS Foundation Trust (Guy's Cancer Centre) Recruiting
London, United Kingdom, SE1 9RT
The Royal Marsden NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6JJ
Imperial College London Recruiting
London, United Kingdom, W12 0HS
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom, M20 4BX
Oxford Cancer Centre Recruiting
Oxford, United Kingdom, OX3 7LE
Poole Hospital NHS Foundation Trust Recruiting
Poole, United Kingdom, BH15 2JB
Royal Preston Hospital Recruiting
Preston, United Kingdom, PR2 9HT
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital Recruiting
Sutton, United Kingdom, SM2 5PT
South West Wales Cancer Centre - Singleton Hospital Recruiting
Swansea, United Kingdom, SA2 8QA
Musgrove Park Hospital Recruiting
Taunton, United Kingdom, TA1 5DA
Sponsors and Collaborators
Clovis Oncology, Inc.
Bristol-Myers Squibb
Gynecologic Oncology Group
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Foundation Medicine
Investigators
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Principal Investigator: Bradley Monk, MD, FACS, FACOG Lead Investigator and Coordinating Investigator for North America
Principal Investigator: Rebecca Kristeleit, Bsc MBChB FRCP PhD Coordinating Investigator for Europe, Middle East, and all Other Regions

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Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT03522246     History of Changes
Other Study ID Numbers: CO-338-087/GOG-3020/ENGOT-ov45
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clovis Oncology, Inc.:
ATHENA
Rucaparib
PARP inhibitor
PARPi
HRD
homologous recombination
DNA repair
LOH
DNA defect
DNA anomaly
Nivolumab
PD-1
Immuno-
oncology
Tumor
mutational
burden
BRCA
First-line
Primary Therapy
Primary Treatment
Additional relevant MeSH terms:
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Rucaparib
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action