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

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fallopian Tube Cancer; Epithelial Ovarian Cancer; Primary Peritoneal; Newly Diagnosed; FIGO Stage III-IV; Partial Response; Complete Response
• Intervention / Treatment: Drug: Rucaparib; Drug: Nivolumab; Drug: Placebo IV Infusion; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 1097
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • New Lambton Heights, New South Wales, Australia, 2145
      • Newcastle Private Hospital
    • Saint Leonards, New South Wales, Australia, 2065
      • Northern Cancer Institute St Leonards
    • Sydney, New South Wales, Australia, 2031
      • Prince of Wales Hospital
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • Brisbane, Queensland, Australia, 4020
      • Royal Brisbane and Women's Hospital
  • South Australia
    • Toorak Gardens, South Australia, Australia, 5065
      • Brian Fricker Oncology Centre, Burnside Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Center
  • Western Australia
    • Subiaco, Western Australia, Australia, 6005
      • St John of God Subiaco Hospital
• Belgium
  • Leuven, Belgium, 3000
    • UZ Leven
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • Alberta Health Services - University of Calgary
    • Edmonton, Alberta, Canada, T6G 2B7
      • Alberta Health Services and The University of Alberta
  • British Columbia
    • Abbotsford, British Columbia, Canada, V2S 0C2
      • Bc Cancer - Abbotsford
    • Kelowna, British Columbia, Canada, V1Y 5L3
      • BC Cancer - Kelowna
    • Surrey, British Columbia, Canada, V3V 1Z2
      • BC Cancer - Surrey
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • CancerCare Manitoba
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Nsha-Qeii Hsc
  • Ontario
    • Hamilton, Ontario, Canada, LbV 5C2
      • Juravinski Cancer Center
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Center
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Cancer Centre
  • Quebec
    • Montréal, Quebec, Canada, H4A 3J1
      • McGill University Health Center
    • Montréal, Quebec, Canada, H2X 0C2
      • Centre Hospitalier de l'Université de Montréal
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Integre Universitaire de sante et de service sociaux de l'Estri-Centre hospitalier univeritaire de Sherbrooke
• Czechia
  • Brno, Czechia, 65653
    • Masaryk Memorial Cancer Institute
  • Prague, Czechia
    • Department of Gynecology and Obstetrics, Oncogynecological center U hiversity Hospital Kralovske Vinohrady
  • Zlín, Czechia
    • KOC KNTB a.s. Zlfn, Hvalfckovo nabrezf 600, 76001
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University Hospital
  • Odense, Denmark, 5000
    • Odense University Hospital
• Finland
  • Kuopio, Finland, 70210
    • Kuopio University Hospital
• Germany
  • Dessau, Germany
    • Klinik für Frauenheilkunde und Geburtshilfe
  • Duesseldorf, Germany
    • Universitaetsklinikum Duesseldorf / Klinik fur Frauenheilkunde & Geburtshilfe
  • Heidelberg, Germany
    • Universitatsklinikum National Centrum for Tumor Disease (NCT)
  • Mannheim, Germany
    • Universitätslinikum Mannheim, Frauenklinik
  • Traunstein, Germany
    • Kliniken Suedostbayern AG, Klinikum Traunstein
• Greece
  • Athens, Greece, 11528
    • Alexandra Hospital
  • Patra, Greece, 26335
    • General Hospital of Patras
  • Thessaloniki, Greece, 5465
    • Euromedica General Clinic, B' Oncology Clinic
  • Athens
    • Chaidari, Athens, Greece, 12462
      • Attikon General University Hospital
    • Chaidari, Athens, Greece, 12462
      • University Hospital Attikon
• Ireland
  • Cork, Ireland
    • Bon Secours Hospital
  • Cork, Ireland, T12 DC4A
    • Cork University Hospital
  • Limerick, Ireland, V94 F858
    • University Hospital Limerick
  • Waterford, Ireland, X91 ER8E
    • University Hospital Waterford
• Israel
  • Jerusalem, Israel
    • Shaare Zedek Medical Oncology
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Nahariya, Israel, 2210001
    • Galilee Medical Center
  • Ramat Gan, Israel, 5265601
    • Sheba Medical Center
  • Safed, Israel, 13100
    • Ziv Medical Center
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Center
• Italy
  • Aviano, Italy, 33081
    • Centro di Riferimento Oncologico, CRO-IRCCS
  • Candiolo, Italy, 10060
    • Candiolo Cancer Institute - IRCCS
  • Catania, Italy, 95122
    • ARNAS Garibaldi
  • Chieti, Italy
    • University G, D'Annunuzio-Chieti
  • Napoli, Italy, 80131
    • IRCCS Instituto Nazionale Tumori
  • Roma, Italy, 00186
    • Ospedale S. Giovanni Calibita Fatebenefratelli
  • Roma, Italy, 00168
    • Policlinico Agostino Gemelli
  • Roma, Italy, 00161
    • Azienda Ospedaliera Universitaria Policlinico Umberto I
  • Vicenza, Italy, 36100
    • Ospedale San Bortolo
• Japan
  • Saitama, Japan, 362-0806
    • Saitama Cancer Center
  • Takamatsu, Japan
    • Kagawa Prefectural Central Hospital
  • Tokyo, Japan, 104-0045
    • National Cancer Center Hospital
  • Amakubo
    • Tsukuba, Amakubo, Japan
      • University of Tsukuba Hospital
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Kurume University Hospital
  • Fukuura
    • Yokohama, Fukuura, Japan
      • Yokohama City University Hospital
  • Gunma
    • Maebashi, Gunma, Japan, 371-8511
      • Gunma University Hospital
    • Ota-shi, Gunma, Japan, 373-8550
      • Gunma Prefectural Cancer Center
  • Hiroshima
    • Naka, Hiroshima, Japan, 730-0844,
      • Hiroshima City Hiroshima Citizens Hospital
  • Hyogo
    • Akashi, Hyogo, Japan, 673-0021
      • Hyogo Cancer Center
  • Iwate
    • Morioka, Iwate, Japan
      • Iwate Medical University
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 211-8533
      • Nippon Medical School Musashikosugi Hospital
    • Yokohama, Kanagawa, Japan, 241-8515
      • Kanagawa cancer center
  • Namiki
    • Tokorozawa, Namiki, Japan
      • National Defense Medical College hospital
  • Osaka
    • Chuo, Osaka, Japan, 541-8567
      • Osaka International Cancer Institute
    • Ōsaka-sayama, Osaka, Japan, 589-8511
      • Kindai University Hospital
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Saitama Medical University International Medical Center
  • Shinanomachi
    • Shinjuku-Ku, Shinanomachi, Japan
      • Keio university hospital
  • Tokyo
    • Koto-Ku, Tokyo, Japan
      • The Cancer Institute Hospital of JFCR
• Korea, Republic of
  • Cheonan, Korea, Republic of
    • Soonchunhyang University Cheonan Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05030
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 01812
    • Korea Cancer Center Hospital
  • Suwon-si, Korea, Republic of
    • Ajou University Hospital
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
      • National Cancer Center
    • Seongnam, Gyeonggi-do, Korea, Republic of, 13496
      • CHA Bundang Medical Center
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
  • Seoul
    • Incheon, Seoul, Korea, Republic of, 21565
      • Gachon University Gil Medical Center
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital
  • Christchurch, New Zealand, 8011
    • Christchurch Hospital
  • Hamilton, New Zealand, 3204
    • Waikato Hospital
  • Palmerston North, New Zealand, 4442
    • Palmerston North Hospital
  • Tauranga, New Zealand, 3112
    • Tauranga Hospital
• Poland
  • Bialystok, Poland, 20-081
    • Bialostockie Centrum Onkologii Oddzial Onkologii Ginekologicznej
  • Białystok, Poland
    • University Hospital of Bialystok
  • Gdynia, Poland, 81-519
    • Szpitale Pomorskie sp zoo
  • Lublin, Poland, 20-081
    • Medical University of Lublin
  • Poznań, Poland, 61-866
    • Wielkopolskie Centrum Onkologii
  • Szczecin, Poland
    • Pomeranian Medical University
  • Kondratowicza
    • Warsaw, Kondratowicza, Poland
      • Chair & department of Obsterics, Gynaecology and Oncology (previous site)
• Romania
  • Baia Mare, Romania
    • Oncopremium Team
  • Bucuresti, Romania
    • SC Quantum Medical Center SRL
  • Cluj-Napoca, Romania
    • Instiute of Oncology - Medical Oncology
  • Craiova, Romania, 200347
    • Centrul de Oncologie Sf.Nectarie
  • Craiova, Romania
    • S.C Oncolab S.R.L
  • Iaşi, Romania, 700489
    • Institutul Regional de Oncologie Iasi
  • Ploieşti, Romania
    • Spital Municipal Ploiesti
  • Suceava, Romania, 720237
    • Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" Suceava
  • Timişoara, Romania, 300239
    • ONCOMED Timisoara
  • Jud. Bihor
    • Oradea, Jud. Bihor, Romania, 410469
      • Spitalul Clinic Municipal "Dr. Gavril Curteanu"
  • Jud. Cluj
    • Cluj-Napoca, Jud. Cluj, Romania, 400641
      • S.C. Medisprof S.R.L.
• Russian Federation
  • Arkhangel'sk, Russian Federation, 163045
    • Arkhangelsk Clinical Oncological Dispensary
  • Omsk, Russian Federation, 644013
    • BHI of Omsk region Clinical Oncology Dispensary
  • Orenburg, Russian Federation
    • Orenburg Regional Clinical Oncological Dispensary
  • Pesochnyy, Russian Federation, 197758
    • SBHI Saint Petersburg Research Center specialized types of medical care (Oncology)
  • Pyatigorsk, Russian Federation, 357502
    • SBHI SR Pyatigorsk Interdistrict Oncology Dispensary
  • Saint Petersburg, Russian Federation, 194356
    • Limited Liability Company MedPomosch
  • Saint Petersburg, Russian Federation, 197022
    • FSBEI HE I.P. Pavlov SPbSMU MoH Russia
  • Saint Petersburg, Russian Federation, 198255
    • Saint-Petersburg State Budget Institution of Healthcare City Clinical Oncology Dispensary
  • Saint Petersburg, Russian Federation
    • 1st Medical University
  • Saransk, Russian Federation, 430032
    • Federa; State Budgetary Educational Institution of Higher Education National Research Ogarev Mordovia State University
  • Sotchi, Russian Federation, 354057
    • State Medical Institution "Oncology Center #2" under the Krasnodar Region Healthcare Department
• Singapore
  • Singapore, Singapore, 119082
    • National University Hospital
  • Singapore, Singapore
    • National Cancer Center Singapore
• Spain
  • Barcelona, Spain, 08035
    • Vall d'Hebron Institute of Oncology
  • Barcelona, Spain, 08041
    • Hospital De La Santa Creu I Sant Pau
  • Bilbao, Spain, 48013
    • Hospital Universitario Basurto
  • Castillón, Spain, 12002
    • Consorcio Hospitalario Provincial Castellon
  • El Palmar, Spain, 30120
    • Hospital Virgen de la Arrixaca
  • Jerez de la Frontera, Spain, 11407
    • Hospital de Jerez
  • Madrid, Spain, 28222
    • Hospital Universitario Puerta de Hierro - Majadahonda
  • Oviedo, Spain, 33011
    • Hospital Universitario Central de Asturias
  • Palma De Mallorca, Spain, 07198
    • Hospital Son Llatzer
  • Sevilla, Spain, 41014
    • Hospital Nuestra Senora de Valme
• Sweden
  • Linköping, Sweden
    • Onkologiska Kliniken
  • Lund, Sweden
    • Onkologiska Kliniken
  • Stockholm, Sweden
    • Karolinska Universitetssjukhuset
• Taiwan
  • Hualien City, Taiwan
    • Hualien Tzu Chi Hospital
  • Kaohsiung, Taiwan, 81362
    • Kaohsiung Veterans General Hospital
  • New Taipei City, Taiwan, 22060
    • Far Eastern Memorial Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taichung, Taiwan
    • China Medical University Hospital
  • Tainan, Taiwan
    • Chi Mei Hospital, Liouying (CMHLY)
  • Tainan, Taiwan
    • Chi Mei Medical Center (CMMC)
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 11490
    • Tri-Service General Hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
  • Taipei, Taiwan
    • Taipei Medical University Hospital
  • Taipei, Taiwan, 10048
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 33305
    • Chang Gung Medical Foundation- Linkou Branch
• Turkey
  • Ankara, Turkey
    • Dr. Abdurrahman Yurtaslan Ankara Women's Health Education and Research Hospital
  • Istanbul, Turkey
    • İstanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine
  • Istanbul, Turkey
    • Koc University School of Medicine, Koc University Hospital
  • Manisa, Turkey, 45030
    • Celal Bayar University Faculty of Medicine
  • Yuregir, Turkey
    • Baskent University Hospital
• United Kingdom
  • Brighton, United Kingdom, BN2 3EH
    • Royal Sussex County Hospital
  • Bristol, United Kingdom, BS2 8HW
    • Bristol Cancer Institute Medical Oncology
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrookes Hospital
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital
  • Lancaster, United Kingdom, LA1 4RP
    • University Hospitals of Morecambe Bay NHS Foundation Trust
  • Leeds, United Kingdom, LS9 7TF
    • St. James University Hospital
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust
  • London, United Kingdom, W12 0HS
    • Imperial College London
  • London, United Kingdom, EC1A 7BE
    • Barts and the London NHS Trust
  • London, United Kingdom, NW1 2PG
    • University of College London Hospital
  • London, United Kingdom, SE1 9RT
    • Guy's & St Thomas' NHS Foundation Trust (Guy's Cancer Centre)
  • Middlesbrough, United Kingdom, TS4 3BW
    • The James Cook University Hospital
  • Poole, United Kingdom, BH15 2JB
    • Poole Hospital NHS Foundation Trust
  • Swansea, United Kingdom, SA2 8QA
    • South West Wales Cancer Centre - Singleton Hospital
  • Taunton, United Kingdom, TA1 5DA
    • Musgrove Park Hospital
  • Kent
    • Canterbury, Kent, United Kingdom, CT1 3NG
      • East Kent Hospitals University NHS Foundation trust Medical Oncology
  • Northampton
    • Cliftonville, Northampton, United Kingdom, NN1 5BD
      • Northampton General Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Oncology Associates, PC - HAL
    • Tucson, Arizona, United States, 85724
      • The University of Arizona Cancer Center
    • Tucson, Arizona, United States, 85711
      • Arizona Oncology Associates, PC - HOPE
  • California
    • Concord, California, United States, 94520
      • John Muir Clinical Research Center
    • Los Angeles, California, United States, 90095
      • UCLA Women's Health Clinical Research Unit
    • San Francisco, California, United States, 94589
      • Kaiser Permanente Northern California
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center
    • Lakewood, Colorado, United States, 80228
      • Rocky Mountain Cancer Centers
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
  • Florida
    • Fort Myers, Florida, United States, 33905
      • Florida Gynecologic Oncology
    • Jacksonville, Florida, United States, 32207
      • MD Anderson Cancer Center-Baptist
    • Miami, Florida, United States, 33176
      • Baptist Health Medical Group Oncology, LLC
    • Orlando, Florida, United States, 32804
      • Florida Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital
    • Augusta, Georgia, United States, 30912
      • Augusta University
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Hinsdale, Illinois, United States, 60521
      • Dr. Sudarshan K. Sharma, Ltd - Gynecologic Oncology
    • Springfield, Illinois, United States, 62769
      • Ferrell-Duncan Clinic
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Community Health Network
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Cancer Center
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
    • Louisville, Kentucky, United States, 40241
      • Norton Cancer Institute
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • SKCCC at Johns Hopkins
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Metro Minnesota Community Oncology Research Consortium
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Women's Cancer Center of Nevada
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • MD Anderson Cancer Center at Cooper
    • Florham Park, New Jersey, United States, 07932
      • Summit Medical Group
  • New York
    • Albany, New York, United States, 12008
      • Women's Cancer Care Associates
    • Johnson City, New York, United States, 13790
      • Broome Oncology, LLC
    • Lake Success, New York, United States, 11042
      • Northwell Health Monter Cancer Center
    • New York, New York, United States, 10016
      • New York University Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27707
      • University of North Carolina
  • Ohio
    • Cincinnati, Ohio, United States, 45221
      • University of Cincinnati
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care, Inc
    • Cleveland, Ohio, United States, 44106
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
    • Columbus, Ohio, United States, 44907
      • MD Anderson Cancer Center - Ohio Health
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Science Center
    • Tulsa, Oklahoma, United States, 74146
      • Oklahoma Cancer Specialists and Research Institute
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Oncology Associates of Oregon, P.C.
    • Portland, Oregon, United States, 97225
      • Northwest Cancer Specialists, P.C.
    • Portland, Oregon, United States, 97210
      • LMG Gynecologic Oncology
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Magee-Womens Hospital
    • Willow Grove, Pennsylvania, United States, 19090
      • Abington Memorial Hospital
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Gynecologic Oncology
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Oncology - Austin Central
    • Bedford, Texas, United States, 76022
      • Texas Oncology - Bedford
    • Dallas, Texas, United States, 75231
      • Texas Oncology - Dallas Presbyterian Hospital
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology - Fort Worth
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Memorial Hermann
    • San Antonio, Texas, United States, 78240
      • Texas Oncology - San Antonio Medical Center
    • The Woodlands, Texas, United States, 77380
      • Texas Oncology - The Woodlands, Gynecologic Oncology
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert and Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm D; Oral placebo + IV placebo	Drug: Placebo IV Infusion; IV placebo will be administered once every 4 weeks; Drug: Placebo Oral Tablet; Placebo tablets will be administered twice daily
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: BMS-936558; Opdivo
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: BMS-936558; Opdivo; Drug: Placebo Oral Tablet; Placebo tablets will be administered twice daily
Experimental: Japanese Open-label Safety Cohort; Oral rucaparib + 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: BMS-936558; Opdivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS)	PFS by investigator was defined as the time from randomization to disease progression, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).	From randomization until disease progression (up to the primary data analysis at approximately 39 months)
Monotherapy Arm B and Arm D: Investigator Assessed PFS	PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).	From randomization until disease progression (up to the primary data analysis at approximately 39 months)
Combination Therapy Arm A and Arm B: Investigator Assessed PFS	PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).	From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monotherapy Arm B and Arm D: Blinded Independent Central Review (BICR) PFS	PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).	From randomization until disease progression (up to the primary data analysis at approximately 39 months)
Monotherapy Arm B and Arm D: BICR PFS	PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).	From randomization until disease progression (up to the primary data analysis at approximately 39 months)
Combination Therapy Arm A and Arm B: BICR PFS	PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).	From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)
Monotherapy Arm B and Arm D: Overall Survival (OS)	OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause.	From randomization until death due to any cause (up to the primary data analysis at approximately 36 months)
Monotherapy Arm B and Arm D: OS	OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause.	From randomization until death due to any cause (up to the primary data analysis at approximately 40 months)
Combination Therapy Arm A and Arm B: OS	OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause.	From randomization until death due to any cause (up to the combination therapy interim analysis at approximately 72 months)
Monotherapy Arm B and Arm D: Objective Response Rate (ORR)	ORR was defined as the percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the Investigator per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.	From randomization until disease progression (up to the primary data analysis at approximately 39 months)
Monotherapy Arm B and Arm D: ORR	ORR was defined as the percentage of participants with CR or PR as assessed by the Investigator per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.	From randomization until disease progression (up to the primary data analysis at approximately 39 months)
Combination Therapy Arm A and Arm B: ORR	ORR was defined as the percentage of participants with CR or PR as assessed by the Investigator per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.	From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)
Monotherapy Arm B and Arm D: Duration of Response (DOR)	DOR was assessed by the investigator and defined as the interval from the first documentation of objective response (CR or PR per RECIST v1.1) to the earlier of the first documentation of progressive disease (PD) or death from any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).	From first confirmed response until disease progression (up to the primary data analysis at approximately 30 months)
Monotherapy Arm B and Arm D: DOR	DOR was assessed by the investigator and defined as the interval from the first documentation of objective response (CR or PR per RECIST v1.1) to the earlier of the first documentation of PD or death from any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).	From first confirmed response until disease progression (up to the primary data analysis at approximately 33 months)
Combination Therapy Arm A and Arm B: DOR	DOR was assessed by the investigator and defined as the interval from the first documentation of objective response (CR or PR per RECIST v1.1) to the earlier of the first documentation of PD or death from any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).	From first confirmed response until disease progression (up to the combination therapy interim analysis at approximately 60 months)

Collaborators and Investigators

• Sponsor: pharmaand GmbH
• Collaborators: Bristol-Myers Squibb; Gynecologic Oncology Group; European Network of Gynaecological Oncological Trial Groups (ENGOT); Foundation Medicine
• Investigators: 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 and the Middle East; Principal Investigator: Keiichi Fujiwara, MD, PhD, Lead Investigator for Asia

Publications and helpful links

General Publications

• Monk BJ, Parkinson C, Lim MC, O'Malley DM, Oaknin A, Wilson MK, Coleman RL, Lorusso D, Bessette P, Ghamande S, Christopoulou A, Provencher D, Prendergast E, Demirkiran F, Mikheeva O, Yeku O, Chudecka-Glaz A, Schenker M, Littell RD, Safra T, Chou HH, Morgan MA, Drochytek V, Barlin JN, Van Gorp T, Ueland F, Lindahl G, Anderson C, Collins DC, Moore K, Marme F, Westin SN, McNeish IA, Shih D, Lin KK, Goble S, Hume S, Fujiwara K, Kristeleit RS. A Randomized, Phase III Trial to Evaluate Rucaparib Monotherapy as Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer (ATHENA-MONO/GOG-3020/ENGOT-ov45). J Clin Oncol. 2022 Dec 1;40(34):3952-3964. doi: 10.1200/JCO.22.01003. Epub 2022 Jun 6.
• Monk BJ, Coleman RL, Fujiwara K, Wilson MK, Oza AM, Oaknin A, O'Malley DM, Lorusso D, Westin SN, Safra T, Herzog TJ, Marme F, N Eskander R, Lin KK, Shih D, Goble S, Grechko N, Hume S, Maloney L, McNeish IA, Kristeleit RS. ATHENA (GOG-3020/ENGOT-ov45): a randomized, phase III trial to evaluate rucaparib as monotherapy (ATHENA-MONO) and rucaparib in combination with nivolumab (ATHENA-COMBO) as maintenance treatment following frontline platinum-based chemotherapy in ovarian cancer. Int J Gynecol Cancer. 2021 Dec;31(12):1589-1594. doi: 10.1136/ijgc-2021-002933. Epub 2021 Sep 30.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2018
• Primary Completion (Actual): May 20, 2024
• Study Completion (Estimated): December 30, 2030

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Nivolumab; oncology; PARP inhibitor; PD-1; Tumor; Rucaparib; burden; BRCA; PARPi; LOH; First-line; HRD; ATHENA; homologous recombination; DNA defect; DNA repair; DNA anomaly; Immuno-; mutational; Primary Therapy; Primary Treatment
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Genital Diseases, Female; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Carcinoma; Fallopian Tube Diseases; Carcinoma, Ovarian Epithelial; Ovarian Neoplasms; Fallopian Tube Neoplasms; Antineoplastic Agents, Immunological; Poly(ADP-ribose) Polymerase Inhibitors; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Nivolumab; Rucaparib
• Other Study ID Numbers: CO-338-087/GOG-3020/ENGOT-ov45; 2017-004557-17 (EudraCT Number); 2024-516662-11-00 (Ctis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No