AzTrials
AzTrials

Epithelial Ovarian CancerPhase 3ATHENANCT03522246

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

A Phase 3 study testing Rucaparib and Nivolumab in people with Epithelial Ovarian Cancer and Primary Peritoneal, run by pharmaand GmbH at 238 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Rucaparib and Nivolumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,097 participants
Where
238 sitesin 24 countries
Study dates
14 May 2018to 30 Dec 2030
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

238 sites in 24 countries.

238 sites in 24 countries

United States64 sites

  • Women's Cancer Care Associates

    Albany, New York, 12008

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Augusta University

    Augusta, Georgia, 30912

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Texas Oncology - Austin Central

    Austin, Texas, 78731

  • SKCCC at Johns Hopkins

    Baltimore, Maryland, 21287

  • Texas Oncology - Bedford

    Bedford, Texas, 76022

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • MD Anderson Cancer Center at Cooper

    Camden, New Jersey, 08103

  • University of North Carolina

    Chapel Hill, North Carolina, 27707

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Cincinnati

    Cincinnati, Ohio, 45221

  • Oncology Hematology Care, Inc

    Cincinnati, Ohio, 45242

  • Cleveland Clinic

    Cleveland, Ohio, 44106

  • The Ohio State University

    Columbus, Ohio, 43210

  • MD Anderson Cancer Center - Ohio Health

    Columbus, Ohio, 44907

  • John Muir Clinical Research Center

    Concord, California, 94520

  • Texas Oncology - Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Oncology Associates of Oregon, P.C.

    Eugene, Oregon, 97401

  • Summit Medical Group

    Florham Park, New Jersey, 07932

  • Florida Gynecologic Oncology

    Fort Myers, Florida, 33905

  • Texas Oncology - Fort Worth

    Fort Worth, Texas, 76104

  • Dr. Sudarshan K. Sharma, Ltd - Gynecologic Oncology

    Hinsdale, Illinois, 60521

  • Memorial Hermann

    Houston, Texas, 77030

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Community Health Network

    Indianapolis, Indiana, 46250

  • University of Iowa Hospitals

    Iowa City, Iowa, 52242

  • MD Anderson Cancer Center-Baptist

    Jacksonville, Florida, 32207

  • Broome Oncology, LLC

    Johnson City, New York, 13790

  • Northwell Health Monter Cancer Center

    Lake Success, New York, 11042

  • Rocky Mountain Cancer Centers

    Lakewood, Colorado, 80228

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89169

  • University of Kentucky

    Lexington, Kentucky, 40536

  • UCLA Women's Health Clinical Research Unit

    Los Angeles, California, 90095

  • Norton Cancer Institute

    Louisville, Kentucky, 40241

  • Baptist Health Medical Group Oncology, LLC

    Miami, Florida, 33176

  • Froedtert and Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Yale University

    New Haven, Connecticut, 06520

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • New York University Medical Center

    New York, New York, 10016

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • University of Oklahoma Health Science Center

    Oklahoma City, Oklahoma, 73104

  • Florida Hospital

    Orlando, Florida, 32804

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Arizona Oncology Associates, PC - HAL

    Phoenix, Arizona, 85016

  • UPMC Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • LMG Gynecologic Oncology

    Portland, Oregon, 97210

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97225

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Texas Oncology - San Antonio Medical Center

    San Antonio, Texas, 78240

  • Kaiser Permanente Northern California

    San Francisco, California, 94589

  • Maine Medical Center

    Scarborough, Maine, 04074

  • Avera Gynecologic Oncology

    Sioux Falls, South Dakota, 57105

  • Ferrell-Duncan Clinic

    Springfield, Illinois, 62769

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Texas Oncology - The Woodlands, Gynecologic Oncology

    The Woodlands, Texas, 77380

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85711

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85724

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa, Oklahoma, 74146

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

  • Abington Memorial Hospital

    Willow Grove, Pennsylvania, 19090

Other trials in United States

Japan20 sites

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-0021

  • Osaka International Cancer Institute

    Chuo, Osaka, 541-8567

  • Saitama Medical University International Medical Center

    Hidaka, Saitama, 350-1298

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Nippon Medical School Musashikosugi Hospital

    Kawasaki-shi, Kanagawa, 211-8533

  • The Cancer Institute Hospital of JFCR

    Koto-Ku, Tokyo

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

  • Iwate Medical University

    Morioka, Iwate

  • Hiroshima City Hiroshima Citizens Hospital

    Naka, Hiroshima, 730-0844,

  • Kindai University Hospital

    Ōsaka-sayama, Osaka, 589-8511

  • Gunma Prefectural Cancer Center

    Ota-shi, Gunma, 373-8550

  • Saitama Cancer Center

    Saitama, 362-0806

  • Keio University Hospital

    Shinjuku-Ku, Shinanomachi

  • Kagawa Prefectural Central Hospital

    Takamatsu

  • National Defense Medical College Hospital

    Tokorozawa, Namiki

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • University of Tsukuba Hospital

    Tsukuba, Amakubo

  • Yokohama City University Hospital

    Yokohama, Fukuura

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

United Kingdom17 sites

  • Royal Sussex County Hospital

    Brighton, BN2 3EH

  • Bristol Cancer Institute Medical Oncology

    Bristol, BS2 8HW

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • East Kent Hospitals University NHS Foundation trust Medical Oncology

    Canterbury, Kent, CT1 3NG

  • Northampton General Hospital

    Cliftonville, Northampton, NN1 5BD

  • Western General Hospital

    Edinburgh, EH4 2XU

  • University Hospitals of Morecambe Bay NHS Foundation Trust

    Lancaster, LA1 4RP

  • St. James University Hospital

    Leeds, LS9 7TF

  • Barts and the London NHS Trust

    London, EC1A 7BE

  • University of College London Hospital

    London, NW1 2PG

  • Guy's & St Thomas' NHS Foundation Trust (Guy's Cancer Centre)

    London, SE1 9RT

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • Imperial College London

    London, W12 0HS

  • The James Cook University Hospital

    Middlesbrough, TS4 3BW

  • Poole Hospital NHS Foundation Trust

    Poole, BH15 2JB

  • South West Wales Cancer Centre - Singleton Hospital

    Swansea, SA2 8QA

  • Musgrove Park Hospital

    Taunton, TA1 5DA

Other trials in United Kingdom

Canada13 sites

  • BC Cancer - Abbotsford

    Abbotsford British Columbia, British Columbia, V2S 0C2

  • Alberta Health Services - University of Calgary

    Calgary, Alberta, T2N 1N4

  • Alberta Health Services and The University of Alberta

    Edmonton, Alberta, T6G 2B7

  • Nsha-Qeii Hsc

    Halifax, Nova Scotia, B3H 2Y9

  • Juravinski Cancer Center

    Hamilton, Ontario, LbV 5C2

  • BC Cancer - Kelowna

    Kelowna, British Columbia, V1Y 5L3

  • London Health Sciences Center

    London, Ontario, N6A 5W9

  • Centre Hospitalier de l'Université de Montreal

    Montreal, Quebec, H2X 0C2

  • McGill University Health Center

    Montreal, Quebec, H4A 3J1

  • Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Centre Integre Universitaire de sante et de service sociaux de l'Estri-Centre hospitalier univeritaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • BC Cancer - Surrey

    Surrey, British Columbia, V3V 1Z2

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

South Korea13 sites

  • SoonChunHyang University Cheonan Hospital

    Cheonan

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Gachon University Gil Medical Center

    Incheon, Seoul, 21565

  • CHA Bundang Medical Center

    Seongnam-si, Gyeonggi-do, 13496

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Korea Cancer Center Hospital

    Seoul, 01812

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Konkuk University Medical Center

    Seoul, 05030

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Korea University Guro Hospital

    Seoul

  • Ajou University Hospital

    Suwon

Other trials in South Korea

Taiwan13 sites

  • Hualien Tzu Chi Hospital

    Hualien City

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

  • Far Eastern Memorial Hospital

    New Taipei City, 22060

  • Taichung Veterans General Hospital

    Taichung, 40705

  • China Medical University Hospital

    Taichung

  • Chi Mei Hospital, Liouying (CMHLY)

    Tainan

  • Chi Mei Medical Center (CMMC)

    Tainan

  • National Taiwan University Hospital

    Taipei, 10048

  • Mackay Memorial Hospital

    Taipei, 10449

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Tri-Service General Hospital

    Taipei, 11490

  • Taipei Medical University Hospital

    Taipei

  • Chang Gung Medical Foundation- Linkou Branch

    Taoyuan, 33305

Other trials in Taiwan

Romania11 sites

  • Oncopremium Team

    Baia Mare

  • SC Quantum Medical Center SRL

    Bucharest

  • S.C. Medisprof S.R.L.

    Cluj-Napoca, Jud. Cluj, 400641

  • Instiute of Oncology - Medical Oncology

    Cluj-Napoca

  • Centrul de Oncologie Sf.Nectarie

    Craiova, 200347

  • S.C Oncolab S.R.L

    Craiova

  • Institutul Regional de Oncologie Iasi

    Iași, 700489

  • Spitalul Clinic Municipal "Dr. Gavril Curteanu"

    Oradea, Jud. Bihor, 410469

  • Spital Municipal Ploiesti

    Ploieşti

  • Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" Suceava

    Suceava, 720237

  • ONCOMED Timisoara

    Timișoara, 300239

Other trials in Romania

Russia11 sites

  • Arkhangelsk Clinical Oncological Dispensary

    Arkhangelsk, 163045

  • BHI of Omsk Region Clinical Oncology Dispensary

    Omsk, 644013

  • Orenburg Regional Clinical Oncological Dispensary

    Orenburg

  • SBHI Saint Petersburg Research Center specialized types of medical care (Oncology)

    Pesochnyy, 197758

  • SBHI SR Pyatigorsk Interdistrict Oncology Dispensary

    Pyatigorsk, 357502

  • Limited Liability Company MedPomosch

    Saint Petersburg, 194356

  • FSBEI HE I.P. Pavlov SPbSMU MoH Russia

    Saint Petersburg, 197022

  • Saint-Petersburg State Budget Institution of Healthcare City Clinical Oncology Dispensary

    Saint Petersburg, 198255

  • 1st Medical University

    Saint Petersburg

  • Federa; State Budgetary Educational Institution of Higher Education National Research Ogarev Mordovia State University

    Saransk, 430032

  • State Medical Institution "Oncology Center #2" under the Krasnodar Region Healthcare Department

    Sochi, 354057

Other trials in Russia

Spain10 sites

  • Vall d'Hebron Institute of Oncology

    Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario Basurto

    Bilbao, 48013

  • Consorcio Hospitalario Provincial Castellon

    Castillón, 12002

  • Hospital Virgen de la Arrixaca

    El Palmar, 30120

  • Hospital de Jerez

    Jerez de la Frontera, 11407

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Son Llatzer

    Palma de Mallorca, 07198

  • Hospital Nuestra Señora de Valme

    Seville, 41014

Other trials in Spain

Italy9 sites

  • Centro di Riferimento Oncologico, CRO-IRCCS

    Aviano, 33081

  • Candiolo Cancer Institute - IRCCS

    Candiolo, 10060

  • Arnas Garibaldi

    Catania, 95122

  • University G, D'Annunuzio-Chieti

    Chieti

  • IRCCS Instituto Nazionale Tumori

    Naples, 80131

  • Azienda Ospedaliera Universitaria Policlinico Umberto I

    Roma, 00161

  • Policlinico Agostino Gemelli

    Roma, 00168

  • Ospedale S. Giovanni Calibita Fatebenefratelli

    Roma, 00186

  • Ospedale San Bortolo

    Vicenza, 36100

Other trials in Italy

Australia8 sites

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4020

  • Peter MacCallum Cancer Center

    Melbourne, Victoria, 3000

  • Newcastle Private Hospital

    New Lambton Heights, New South Wales, 2145

  • Northern Cancer Institute St Leonards

    Saint Leonards, New South Wales, 2065

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, 6005

  • Prince of Wales Hospital

    Sydney, New South Wales, 2031

  • Brian Fricker Oncology Centre, Burnside Hospital

    Toorak Gardens, South Australia, 5065

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Poland7 sites

  • Bialostockie Centrum Onkologii Oddzial Onkologii Ginekologicznej

    Bialystok, 20-081

  • University Hospital of Bialystok

    Bialystok

  • Szpitale Pomorskie sp zoo

    Gdynia, 81-519

  • Medical University of Lublin

    Lublin, 20-081

  • Wielkopolskie Centrum Onkologii

    Poznan, 61-866

  • Pomeranian Medical University

    Szczecin

  • Chair & department of Obsterics, Gynaecology and Oncology (previous site)

    Warsaw, Kondratowicza

Other trials in Poland

Israel6 sites

  • Shaare Zedek Medical Oncology

    Jerusalem

  • Meir Medical Center

    Kfar Saba, 4428164

  • Galilee Medical Center

    Nahariya, 2210001

  • Sheba Medical Center

    Ramat Gan, 5265601

  • Ziv Medical Center

    Safed, 13100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Germany5 sites

  • Klinik für Frauenheilkunde und Geburtshilfe

    Dessau

  • Universitaetsklinikum Duesseldorf / Klinik fur Frauenheilkunde & Geburtshilfe

    Düsseldorf

  • Universitatsklinikum National Centrum for Tumor Disease (NCT)

    Heidelberg

  • Universitätslinikum Mannheim, Frauenklinik

    Mannheim

  • Kliniken Suedostbayern AG, Klinikum Traunstein

    Traunstein

Other trials in Germany

Greece5 sites

  • Alexandra Hospital

    Athens, 11528

  • Attikon General University Hospital

    Chaïdári, Athens, 12462

  • University Hospital Attikon

    Chaïdári, Athens, 12462

  • General Hospital of Patras

    Pátrai, 26335

  • Euromedica General Clinic, B' Oncology Clinic

    Thessaloniki, 5465

Other trials in Greece

New Zealand5 sites

  • Auckland City Hospital

    Auckland, 1023

  • Christchurch Hospital

    Christchurch, 8011

  • Waikato Hospital

    Hamilton, 3204

  • Palmerston North Hospital

    Palmerston North, 4442

  • Tauranga Hospital

    Tauranga, 3112

Other trials in New Zealand

Turkey (Türkiye)5 sites

  • Dr. Abdurrahman Yurtaslan Ankara Women's Health Education and Research Hospital

    Ankara

  • Istanbul University-cerrahpasa, Cerrahpasa School of Medicine

    Istanbul

  • Koc University School of Medicine, Koc University Hospital

    Istanbul

  • Celal Bayar University Faculty of Medicine

    Manisa, 45030

  • Baskent University Hospital

    Yüreğir

Other trials in Turkey (Türkiye)

Ireland4 sites

  • Cork University Hospital

    Cork, T12 DC4A

  • Bon Secours Hospital

    Cork

  • University Hospital Limerick

    Limerick, V94 F858

  • University Hospital Waterford

    Waterford, X91 ER8E

Other trials in Ireland

Czechia3 sites

  • Masaryk Memorial Cancer Institute

    Brno, 65653

  • Department of Gynecology and Obstetrics, Oncogynecological center U hiversity Hospital Kralovske Vinohrady

    Prague

  • KOC KNTB a.s. Zlfn, Hvalfckovo nabrezf 600, 76001

    Zlín

Other trials in Czechia

Sweden3 sites

  • Onkologiska Kliniken

    Linköping

  • Onkologiska Kliniken

    Lund

  • Karolinska Universitetssjukhuset

    Stockholm

Other trials in Sweden

Denmark2 sites

  • Aalborg University Hospital

    Aalborg, 9000

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

Singapore2 sites

  • National University Hospital

    Singapore, 119082

  • National Cancer Center Singapore

    Singapore

Other trials in Singapore

Belgium1 site

  • UZ Leven

    Leuven, 3000

Other trials in Belgium

Finland1 site

  • Kuopio University Hospital

    Kuopio, 70210

Other trials in Finland

About this study

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)

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.

Being tested
Rucaparib, Nivolumab, Placebo Oral Tablet, Placebo IV Infusion
Keywords
PARP inhibitor, PARPi, HRD, ATHENA, homologous recombination, DNA repair, LOH, DNA defect, DNA anomaly, Rucaparib, Nivolumab, PD-1, Immuno-, oncology, Tumor, mutational, burden, BRCA, First-line, Primary Therapy
Medical subject headings
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Pathologic Complete Response, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RucaparibDrug

    Also called Rubraca, CO-338

    Oral rucaparib will be administered twice daily

  • NivolumabDrug

    Also called Opdivo, BMS-936558

    IV nivolumab will be administered once every 4 weeks

  • Placebo Oral TabletDrug

    Placebo tablets will be administered twice daily

  • Placebo IV InfusionDrug

    IV placebo will be administered once every 4 weeks

Study groups in NCT03522246
Study groupRoleWhat they receive
Arm AExperimentalOral rucaparib + intravenous (IV) nivolumab
Receives: Drug: Rucaparib; Drug: Nivolumab
Arm BExperimentalOral rucaparib + IV placebo
Receives: Drug: Rucaparib; Drug: Placebo IV Infusion
Arm CExperimentalOral placebo + IV nivolumab
Receives: Drug: Nivolumab; Drug: Placebo Oral Tablet
Arm DPlacebo comparatorOral placebo + IV placebo
Receives: Drug: Placebo Oral Tablet; Drug: Placebo IV Infusion
Japanese Open-label Safety CohortExperimentalOral rucaparib + IV nivolumab
Receives: Drug: Rucaparib; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: From randomization until disease progression (up to the primary data analysis at approximately 39 months)

  2. 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).

    Measured: From randomization until disease progression (up to the primary data analysis at approximately 39 months)

  3. 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).

    Measured: From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)

Secondary outcomes (12)

  1. 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).

    Measured: From randomization until disease progression (up to the primary data analysis at approximately 39 months)

  2. 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).

    Measured: From randomization until disease progression (up to the primary data analysis at approximately 39 months)

  3. 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).

    Measured: From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)

  4. 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.

    Measured: From randomization until death due to any cause (up to the primary data analysis at approximately 36 months)

  5. 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.

    Measured: From randomization until death due to any cause (up to the primary data analysis at approximately 40 months)

  6. 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.

    Measured: From randomization until death due to any cause (up to the combination therapy interim analysis at approximately 72 months)

  7. 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.

    Measured: From randomization until disease progression (up to the primary data analysis at approximately 39 months)

  8. 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.

    Measured: From randomization until disease progression (up to the primary data analysis at approximately 39 months)

  9. 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.

    Measured: From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)

  10. 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).

    Measured: From first confirmed response until disease progression (up to the primary data analysis at approximately 30 months)

  11. 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).

    Measured: From first confirmed response until disease progression (up to the primary data analysis at approximately 33 months)

  12. 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).

    Measured: From first confirmed response until disease progression (up to the combination therapy interim analysis at approximately 60 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2018
  2. Study start14 May 2018
  3. Primary completion20 May 2024
  4. Study completion30 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,097 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03522246
Sponsor's protocol ID
CO-338-087/GOG-3020/ENGOT-ov45
Other IDs
2017-004557-17, 2024-516662-11-00, 2017
Acronym
ATHENA
Status last verified
Jun 2025
First submitted
9 Apr 2018
Last updated
24 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kristeleit RS, Ghamande S, Lisyanskaya A, Oaknin A, Prendergast E, Kim YB, Fuentes Pradera J, Littell RD, Gao B, Valabrega G, O'Malley DM, Dean A, Pisano C, Buscema J, Provencher D, Zagouri F, Martin LP, Chou HH, Demirkiran F, Ueland F, Chudecka-Glaz A, Yeku O, Beiner M, Anderson C, Drochytek V, Eskander RN, Agarwal R, Maloney L, Despain D, Connor C, Craib M, Shih D, Fujiwara K, Monk BJ. Rucaparib maintenance for newly diagnosed advanced ovarian cancer: interim overall survival, progression-free survival, and safety at 5 years of follow-up from the phase III ATHENA-MONO/GOG-3020/ENGOT-ov45 study. Ann Oncol. 2026 Feb;37(2):217-228. doi: 10.1016/j.annonc.2025.10.007. Epub 2025 Oct 18.

    PubMed 41115469

  • 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.

    PubMed 35658487

  • 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.

    PubMed 34593565

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rucaparib and Nivolumab in people with Epithelial Ovarian Cancer and Primary Peritoneal, run by pharmaand GmbH at 238 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 238 sites in United States, Japan, United Kingdom, Canada, South Korea and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS) (time frame: From randomization until disease progression (up to the primary data analysis at approximately 39 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03522246, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.

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