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

NCT ID: NCT03522246

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1097 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-14
• Study Completion Date: 2030-12-30

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.

Conditions

Epithelial Ovarian Cancer; Primary Peritoneal; Fallopian Tube Cancer; Newly Diagnosed; FIGO Stage III-IV; Partial Response; Complete Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm A

Oral rucaparib + intravenous (IV) nivolumab

Group Type: EXPERIMENTAL

Rucaparib

Intervention Type: DRUG

Oral rucaparib will be administered twice daily

Nivolumab

Intervention Type: DRUG

IV nivolumab will be administered once every 4 weeks

Arm B

Oral rucaparib + IV placebo

Group Type: EXPERIMENTAL

Rucaparib

Intervention Type: DRUG

Oral rucaparib will be administered twice daily

Placebo IV Infusion

Intervention Type: DRUG

IV placebo will be administered once every 4 weeks

Arm C

Oral placebo + IV nivolumab

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: DRUG

IV nivolumab will be administered once every 4 weeks

Placebo Oral Tablet

Intervention Type: DRUG

Placebo tablets will be administered twice daily

Arm D

Oral placebo + IV placebo

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

Placebo tablets will be administered twice daily

Placebo IV Infusion

Intervention Type: DRUG

IV placebo will be administered once every 4 weeks

Japanese Open-label Safety Cohort

Oral rucaparib + IV nivolumab

Group Type: EXPERIMENTAL

Rucaparib

Intervention Type: DRUG

Oral rucaparib will be administered twice daily

Nivolumab

Intervention Type: DRUG

IV nivolumab will be administered once every 4 weeks

Interventions

Rucaparib

Oral rucaparib will be administered twice daily

Intervention Type: DRUG

Nivolumab

IV nivolumab will be administered once every 4 weeks

Intervention Type: DRUG

Placebo Oral Tablet

Placebo tablets will be administered twice daily

Intervention Type: DRUG

Placebo IV Infusion

IV placebo will be administered once every 4 weeks

Intervention Type: DRUG

Other Intervention Names

Rubraca; CO-338; Opdivo; BMS-936558

Eligibility Criteria

Inclusion Criteria

• Newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or following neoadjuvant chemotherapy (interval debulking)
• Completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the Investigator
• Sufficient tumor tissue for planned analysis
• ECOG performance status of 0 or 1
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: collaborator

European Network of Gynaecological Oncological Trial Groups (ENGOT)

OTHER

Sponsor Role: collaborator

Foundation Medicine

INDUSTRY

Sponsor Role: collaborator

pharmaand GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Arizona Oncology Associates, PC - HAL

Phoenix, Arizona, United States

Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, United States

The University of Arizona Cancer Center

Tucson, Arizona, United States

John Muir Clinical Research Center

Concord, California, United States

UCLA Women's Health Clinical Research Unit

Los Angeles, California, United States

Kaiser Permanente Northern California

San Francisco, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Rocky Mountain Cancer Centers

Lakewood, Colorado, United States

Yale University

New Haven, Connecticut, United States

Florida Gynecologic Oncology

Fort Myers, Florida, United States

MD Anderson Cancer Center-Baptist

Jacksonville, Florida, United States

Baptist Health Medical Group Oncology, LLC

Miami, Florida, United States

Florida Hospital

Orlando, Florida, United States

Northside Hospital

Atlanta, Georgia, United States

Augusta University

Augusta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Dr. Sudarshan K. Sharma, Ltd - Gynecologic Oncology

Hinsdale, Illinois, United States

Ferrell-Duncan Clinic

Springfield, Illinois, United States

Community Health Network

Indianapolis, Indiana, United States

University of Iowa Hospitals

Iowa City, Iowa, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

University of Kentucky

Lexington, Kentucky, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Maine Medical Center

Scarborough, Maine, United States

SKCCC at Johns Hopkins

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Metro Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Women's Cancer Center of Nevada

Las Vegas, Nevada, United States

MD Anderson Cancer Center at Cooper

Camden, New Jersey, United States

Summit Medical Group

Florham Park, New Jersey, United States

Women's Cancer Care Associates

Albany, New York, United States

Broome Oncology, LLC

Johnson City, New York, United States

Northwell Health Monter Cancer Center

Lake Success, New York, United States

New York University Medical Center

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Oncology Hematology Care, Inc

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

MD Anderson Cancer Center - Ohio Health

Columbus, Ohio, United States

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, United States

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, United States

Oncology Associates of Oregon, P.C.

Eugene, Oregon, United States

LMG Gynecologic Oncology

Portland, Oregon, United States

Northwest Cancer Specialists, P.C.

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Abington Memorial Hospital

Willow Grove, Pennsylvania, United States

Avera Gynecologic Oncology

Sioux Falls, South Dakota, United States

Texas Oncology - Austin Central

Austin, Texas, United States

Texas Oncology - Bedford

Bedford, Texas, United States

Texas Oncology - Dallas Presbyterian Hospital

Dallas, Texas, United States

Texas Oncology - Fort Worth

Fort Worth, Texas, United States

Memorial Hermann

Houston, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Texas Oncology - San Antonio Medical Center

San Antonio, Texas, United States

Texas Oncology - The Woodlands, Gynecologic Oncology

The Woodlands, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Froedtert and Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Newcastle Private Hospital

New Lambton Heights, New South Wales, Australia

Northern Cancer Institute St Leonards

Saint Leonards, New South Wales, Australia

Prince of Wales Hospital

Sydney, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Brian Fricker Oncology Centre, Burnside Hospital

Toorak Gardens, South Australia, Australia

Peter MacCallum Cancer Center

Melbourne, Victoria, Australia

St John of God Subiaco Hospital

Subiaco, Western Australia, Australia

UZ Leven

Leuven, , Belgium

Alberta Health Services - University of Calgary

Calgary, Alberta, Canada

Alberta Health Services and The University of Alberta

Edmonton, Alberta, Canada

BC Cancer - Abbotsford

Abbotsford, British Columbia, Canada

BC Cancer - Kelowna

Kelowna, British Columbia, Canada

BC Cancer - Surrey

Surrey, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Nsha-Qeii Hsc

Halifax, Nova Scotia, Canada

Juravinski Cancer Center

Hamilton, Ontario, Canada

London Health Sciences Center

London, Ontario, Canada

Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Centre Hospitalier de l'Université de Montreal

Montreal, Quebec, Canada

McGill University Health Center

Montreal, Quebec, Canada

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

Sherbrooke, Quebec, Canada

Masaryk Memorial Cancer Institute

Brno, , Czechia

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

Prague, , Czechia

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

Zlín, , Czechia

Aalborg University Hospital

Aalborg, , Denmark

Odense University Hospital

Odense, , Denmark

Kuopio University Hospital

Kuopio, , Finland

Klinik für Frauenheilkunde und Geburtshilfe

Dessau, , Germany

Universitaetsklinikum Duesseldorf / Klinik fur Frauenheilkunde & Geburtshilfe

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, Greece

University Hospital Attikon

Chaïdári, Athens, Greece

Alexandra Hospital

Athens, , Greece

General Hospital of Patras

Pátrai, , Greece

Euromedica General Clinic, B' Oncology Clinic

Thessaloniki, , Greece

Cork University Hospital

Cork, , Ireland

Bon Secours Hospital

Cork, , Ireland

University Hospital Limerick

Limerick, , Ireland

University Hospital Waterford

Waterford, , Ireland

Shaare Zedek Medical Oncology

Jerusalem, , Israel

Meir Medical Center

Kfar Saba, , Israel

Galilee Medical Center

Nahariya, , Israel

Sheba Medical Center

Ramat Gan, , Israel

Ziv Medical Center

Safed, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Centro di Riferimento Oncologico, CRO-IRCCS

Aviano, , Italy

Candiolo Cancer Institute - IRCCS

Candiolo, , Italy

Arnas Garibaldi

Catania, , Italy

University G, D'Annunuzio-Chieti

Chieti, , Italy

IRCCS Instituto Nazionale Tumori

Napoli, , Italy

Azienda Ospedaliera Universitaria Policlinico Umberto I

Roma, , Italy

Policlinico Agostino Gemelli

Roma, , Italy

Ospedale S. Giovanni Calibita Fatebenefratelli

Roma, , Italy

Ospedale San Bortolo

Vicenza, , Italy

University of Tsukuba Hospital

Tsukuba, Amakubo, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Kurume University Hospital

Kurume, Fukuoka, Japan

Yokohama City University Hospital

Yokohama, Fukuura, Japan

Gunma University Hospital

Maebashi, Gunma, Japan

Gunma Prefectural Cancer Center

Ota-shi, Gunma, Japan

Hiroshima City Hiroshima Citizens Hospital

Naka, Hiroshima, Japan

Hyogo Cancer Center

Akashi, Hyōgo, Japan

Iwate Medical University

Morioka, Iwate, Japan

Nippon Medical School Musashikosugi Hospital

Kawasaki-shi, Kanagawa, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

National Defense Medical College Hospital

Tokorozawa, Namiki, Japan

Osaka International Cancer Institute

Chuo, Osaka, Japan

Kindai University Hospital

Ōsaka-sayama, Osaka, Japan

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Keio University Hospital

Shinjuku-Ku, Shinanomachi, Japan

The Cancer Institute Hospital of JFCR

Koto-Ku, Tokyo, Japan

Saitama Cancer Center

Saitama, , Japan

Kagawa Prefectural Central Hospital

Takamatsu, , Japan

National Cancer Center Hospital

Tokyo, , Japan

Auckland City Hospital

Auckland, , New Zealand

Christchurch Hospital

Christchurch, , New Zealand

Waikato Hospital

Hamilton, , New Zealand

Palmerston North Hospital

Palmerston North, , New Zealand

Tauranga Hospital

Tauranga, , New Zealand

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

Warsaw, Kondratowicza, Poland

Bialostockie Centrum Onkologii Oddzial Onkologii Ginekologicznej

Bialystok, , Poland

University Hospital of Bialystok

Bialystok, , Poland

Szpitale Pomorskie sp zoo

Gdynia, , Poland

Medical University of Lublin

Lublin, , Poland

Wielkopolskie Centrum Onkologii

Poznan, , Poland

Pomeranian Medical University

Szczecin, , Poland

Spitalul Clinic Municipal "Dr. Gavril Curteanu"

Oradea, Jud. Bihor, Romania

S.C. Medisprof S.R.L.

Cluj-Napoca, Jud. Cluj, Romania

Oncopremium Team

Baia Mare, , Romania

SC Quantum Medical Center SRL

Bucharest, , Romania

Instiute of Oncology - Medical Oncology

Cluj-Napoca, , Romania

Centrul de Oncologie Sf.Nectarie

Craiova, , Romania

S.C Oncolab S.R.L

Craiova, , Romania

Institutul Regional de Oncologie Iasi

Iași, , Romania

Spital Municipal Ploiesti

Ploieşti, , Romania

Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" Suceava

Suceava, , Romania

ONCOMED Timisoara

Timișoara, , Romania

Arkhangelsk Clinical Oncological Dispensary

Arkhangelsk, , Russia

BHI of Omsk Region Clinical Oncology Dispensary

Omsk, , Russia

Orenburg Regional Clinical Oncological Dispensary

Orenburg, , Russia

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

Pesochnyy, , Russia

SBHI SR Pyatigorsk Interdistrict Oncology Dispensary

Pyatigorsk, , Russia

Limited Liability Company MedPomosch

Saint Petersburg, , Russia

FSBEI HE I.P. Pavlov SPbSMU MoH Russia

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

1st Medical University

Saint Petersburg, , Russia

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

Saransk, , Russia

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

Sochi, , Russia

National University Hospital

Singapore, , Singapore

National Cancer Center Singapore

Singapore, , Singapore

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Gachon University Gil Medical Center

Incheon, Seoul, South Korea

SoonChunHyang University Cheonan Hospital

Cheonan, , South Korea

Korea Cancer Center Hospital

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Konkuk University Medical Center

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Ajou University Hospital

Suwon, , South Korea

Vall d'Hebron Institute of Oncology

Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitario Basurto

Bilbao, , Spain

Consorcio Hospitalario Provincial Castellon

Castillón, , Spain

Hospital Virgen de la Arrixaca

El Palmar, , Spain

Hospital de Jerez

Jerez de la Frontera, , Spain

Hospital Universitario Puerta de Hierro - Majadahonda

Madrid, , Spain

Hospital Universitario Central de Asturias

Oviedo, , Spain

Hospital Son Llatzer

Palma de Mallorca, , Spain

Hospital Nuestra Señora de Valme

Seville, , 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, , Taiwan

Far Eastern Memorial Hospital

New Taipei City, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

Chi Mei Hospital, Liouying (CMHLY)

Tainan City, , Taiwan

Chi Mei Medical Center (CMMC)

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Mackay Memorial Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Taipei Medical University Hospital

Taipei, , Taiwan

Chang Gung Medical Foundation- Linkou Branch

Taoyuan District, , 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, , Turkey (Türkiye)

Baskent University Hospital

Yüreğir, , Turkey (Türkiye)

East Kent Hospitals University NHS Foundation trust Medical Oncology

Canterbury, Kent, United Kingdom

Northampton General Hospital

Cliftonville, Northampton, United Kingdom

Royal Sussex County Hospital

Brighton, , United Kingdom

Bristol Cancer Institute Medical Oncology

Bristol, , United Kingdom

Addenbrookes Hospital

Cambridge, , United Kingdom

Western General Hospital

Edinburgh, , United Kingdom

University Hospitals of Morecambe Bay NHS Foundation Trust

Lancaster, , United Kingdom

St. James University Hospital

Leeds, , United Kingdom

Barts and the London NHS Trust

London, , United Kingdom

University of College London Hospital

London, , United Kingdom

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

London, , United Kingdom

The Royal Marsden NHS Foundation Trust

London, , United Kingdom

Imperial College London

London, , United Kingdom

The James Cook University Hospital

Middlesbrough, , United Kingdom

Poole Hospital NHS Foundation Trust

Poole, , United Kingdom

South West Wales Cancer Centre - Singleton Hospital

Swansea, , United Kingdom

Musgrove Park Hospital

Taunton, , United Kingdom

Countries

United States; Australia; Belgium; Canada; Czechia; Denmark; Finland; Germany; Greece; Ireland; Israel; Italy; Japan; New Zealand; Poland; Romania; Russia; Singapore; South Korea; Spain; Sweden; Taiwan; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35658487 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34593565 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-004557-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2024-516662-11-00

Identifier Type: CTIS

Identifier Source: secondary_id

CO-338-087/GOG-3020/ENGOT-ov45

Identifier Type: -

Identifier Source: org_study_id