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)
3 other identifiers
interventional
1,097
24 countries
238
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2018
Longer than P75 for phase_3
238 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2018
CompletedFirst Posted
Study publicly available on registry
May 11, 2018
CompletedStudy Start
First participant enrolled
May 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2024
CompletedResults Posted
Study results publicly available
June 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2030
ExpectedJune 24, 2025
June 1, 2025
6 years
April 9, 2018
May 13, 2025
June 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (12)
Monotherapy Arm B and Arm D: Blinded Independent Central Review (BICR) PFS
From randomization until disease progression (up to the primary data analysis at approximately 39 months)
Monotherapy Arm B and Arm D: BICR PFS
From randomization until disease progression (up to the primary data analysis at approximately 39 months)
Combination Therapy Arm A and Arm B: BICR PFS
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)
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
From randomization until death due to any cause (up to the primary data analysis at approximately 40 months)
- +7 more secondary outcomes
Study Arms (5)
Arm A
EXPERIMENTALOral rucaparib + intravenous (IV) nivolumab
Arm B
EXPERIMENTALOral rucaparib + IV placebo
Arm C
EXPERIMENTALOral placebo + IV nivolumab
Arm D
PLACEBO COMPARATOROral placebo + IV placebo
Japanese Open-label Safety Cohort
EXPERIMENTALOral rucaparib + IV nivolumab
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- pharmaand GmbHlead
- Bristol-Myers Squibbcollaborator
- Gynecologic Oncology Groupcollaborator
- European Network of Gynaecological Oncological Trial Groups (ENGOT)collaborator
- Foundation Medicinecollaborator
Study Sites (238)
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
Ferrell-Duncan Clinic
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
St 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 1N4, Canada
Alberta Health Services and The University of Alberta
Edmonton, Alberta, T6G 2B7, Canada
BC Cancer - Abbotsford
Abbotsford, British Columbia, V2S 0C2, Canada
BC Cancer - Kelowna
Kelowna, British Columbia, V1Y 5L3, Canada
BC Cancer - Surrey
Surrey, British Columbia, V3V 1Z2, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Nsha-Qeii Hsc
Halifax, Nova Scotia, B3H 2Y9, Canada
Juravinski Cancer Center
Hamilton, Ontario, LbV 5C2, Canada
London Health Sciences Center
London, Ontario, N6A 5W9, Canada
Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Centre Hospitalier de l'Université de Montreal
Montreal, Quebec, H2X 0C2, Canada
McGill University Health Center
Montreal, Quebec, H4A 3J1, Canada
Centre Integre Universitaire de sante et de service sociaux de l'Estri-Centre hospitalier univeritaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, 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
Düsseldorf, 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
Chaïdári, Athens, 12462, Greece
University Hospital Attikon
Chaïdári, Athens, 12462, Greece
Alexandra Hospital
Athens, 11528, Greece
General Hospital of Patras
Pátrai, 26335, Greece
Euromedica General Clinic, B' Oncology Clinic
Thessaloniki, 5465, Greece
Cork University Hospital
Cork, T12 DC4A, Ireland
Bon Secours Hospital
Cork, Ireland
University Hospital Limerick
Limerick, V94 F858, Ireland
University Hospital Waterford
Waterford, X91 ER8E, Ireland
Shaare Zedek Medical Oncology
Jerusalem, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Galilee Medical Center
Nahariya, 2210001, Israel
Sheba Medical Center
Ramat Gan, 5265601, Israel
Ziv Medical Center
Safed, 13100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, 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, 277-8577, Japan
Kurume University Hospital
Kurume, Fukuoka, 830-0011, Japan
Yokohama City University Hospital
Yokohama, Fukuura, Japan
Gunma University Hospital
Maebashi, Gunma, 371-8511, Japan
Gunma Prefectural Cancer Center
Ota-shi, Gunma, 373-8550, Japan
Hiroshima City Hiroshima Citizens Hospital
Naka, Hiroshima, 730-0844,, Japan
Hyogo Cancer Center
Akashi, Hyōgo, 673-0021, Japan
Iwate Medical University
Morioka, Iwate, Japan
Nippon Medical School Musashikosugi Hospital
Kawasaki-shi, Kanagawa, 211-8533, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
National Defense Medical College Hospital
Tokorozawa, Namiki, Japan
Osaka International Cancer Institute
Chuo, Osaka, 541-8567, Japan
Kindai University Hospital
Ōsaka-sayama, Osaka, 589-8511, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298, Japan
Keio University Hospital
Shinjuku-Ku, Shinanomachi, Japan
The Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, Japan
Saitama Cancer Center
Saitama, 362-0806, Japan
Kagawa Prefectural Central Hospital
Takamatsu, Japan
National Cancer Center Hospital
Tokyo, 104-0045, Japan
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, 20-081, Poland
University Hospital of Bialystok
Bialystok, Poland
Szpitale Pomorskie sp zoo
Gdynia, 81-519, Poland
Medical University of Lublin
Lublin, 20-081, Poland
Wielkopolskie Centrum Onkologii
Poznan, 61-866, Poland
Pomeranian Medical University
Szczecin, Poland
Spitalul Clinic Municipal "Dr. Gavril Curteanu"
Oradea, Jud. Bihor, 410469, Romania
S.C. Medisprof S.R.L.
Cluj-Napoca, Jud. Cluj, 400641, Romania
Oncopremium Team
Baia Mare, Romania
SC Quantum Medical Center SRL
Bucharest, Romania
Instiute of Oncology - Medical Oncology
Cluj-Napoca, Romania
Centrul de Oncologie Sf.Nectarie
Craiova, 200347, Romania
S.C Oncolab S.R.L
Craiova, Romania
Institutul Regional de Oncologie Iasi
Iași, 700489, Romania
Spital Municipal Ploiesti
Ploieşti, Romania
Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" Suceava
Suceava, 720237, Romania
ONCOMED Timisoara
Timișoara, 300239, Romania
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, 163045, Russia
BHI of Omsk Region Clinical Oncology Dispensary
Omsk, 644013, Russia
Orenburg Regional Clinical Oncological Dispensary
Orenburg, Russia
SBHI Saint Petersburg Research Center specialized types of medical care (Oncology)
Pesochnyy, 197758, Russia
SBHI SR Pyatigorsk Interdistrict Oncology Dispensary
Pyatigorsk, 357502, Russia
Limited Liability Company MedPomosch
Saint Petersburg, 194356, Russia
FSBEI HE I.P. Pavlov SPbSMU MoH Russia
Saint Petersburg, 197022, Russia
Saint-Petersburg State Budget Institution of Healthcare City Clinical Oncology Dispensary
Saint Petersburg, 198255, Russia
1st Medical University
Saint Petersburg, Russia
Federa; State Budgetary Educational Institution of Higher Education National Research Ogarev Mordovia State University
Saransk, 430032, Russia
State Medical Institution "Oncology Center #2" under the Krasnodar Region Healthcare Department
Sochi, 354057, Russia
National University Hospital
Singapore, 119082, Singapore
National Cancer Center Singapore
Singapore, Singapore
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Gachon University Gil Medical Center
Incheon, Seoul, 21565, South Korea
SoonChunHyang University Cheonan Hospital
Cheonan, South Korea
Korea Cancer Center Hospital
Seoul, 01812, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Korea University Guro Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
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
Seville, 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 City, 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 University Hospital
Taipei, Taiwan
Chang Gung Medical Foundation- Linkou Branch
Taoyuan District, 33305, Taiwan
Dr. Abdurrahman Yurtaslan Ankara Women's Health Education and Research Hospital
Ankara, Turkey (Türkiye)
Istanbul University-cerrahpasa, Cerrahpasa School of Medicine
Istanbul, Turkey (Türkiye)
Koc University School of Medicine, Koc University Hospital
Istanbul, Turkey (Türkiye)
Celal Bayar University Faculty of Medicine
Manisa, 45030, Turkey (Türkiye)
Baskent University Hospital
Yüreğir, Turkey (Türkiye)
East Kent Hospitals University NHS Foundation trust Medical Oncology
Canterbury, Kent, CT1 3NG, United Kingdom
Northampton General Hospital
Cliftonville, Northampton, NN1 5BD, United Kingdom
Royal Sussex County Hospital
Brighton, BN2 3EH, United Kingdom
Bristol Cancer Institute Medical Oncology
Bristol, BS2 8HW, United Kingdom
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster, LA1 4RP, United Kingdom
St. James University Hospital
Leeds, LS9 7TF, United Kingdom
Barts and the London NHS Trust
London, EC1A 7BE, United Kingdom
University of College London Hospital
London, NW1 2PG, United Kingdom
Guy's & St Thomas' NHS Foundation Trust (Guy's Cancer Centre)
London, SE1 9RT, United Kingdom
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
Imperial College London
London, W12 0HS, United Kingdom
The James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
Poole Hospital NHS Foundation Trust
Poole, BH15 2JB, United Kingdom
South West Wales Cancer Centre - Singleton Hospital
Swansea, SA2 8QA, United Kingdom
Musgrove Park Hospital
Taunton, TA1 5DA, United Kingdom
Related Publications (2)
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.
PMID: 35658487DERIVEDMonk 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.
PMID: 34593565DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information Department
- Organization
- pharmaand GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-Blind; only the safety cohort will be open label.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2018
First Posted
May 11, 2018
Study Start
May 14, 2018
Primary Completion
May 20, 2024
Study Completion (Estimated)
December 30, 2030
Last Updated
June 24, 2025
Results First Posted
June 24, 2025
Record last verified: 2025-06