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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,097

Participants

Timeline

Start Date

May 14, 2018

Primary Completion Date

May 20, 2024

Study Completion Date

December 30, 2030

Conditions
Epithelial Ovarian CancerPrimary PeritonealFallopian Tube CancerNewly DiagnosedFIGO Stage III-IVPartial ResponseComplete Response
Interventions
DRUG

Rucaparib

Oral rucaparib will be administered twice daily

DRUG

Nivolumab

IV nivolumab will be administered once every 4 weeks

DRUG

Placebo Oral Tablet

Placebo tablets will be administered twice daily

DRUG

Placebo IV Infusion

IV placebo will be administered once every 4 weeks

Trial Locations (238)

1023

Auckland City Hospital, Auckland

2031

Prince of Wales Hospital, Sydney

2065

Northern Cancer Institute St Leonards, Saint Leonards

2145

Newcastle Private Hospital, New Lambton Heights

Westmead Hospital, Westmead

3000

Peter MacCallum Cancer Center, Melbourne

UZ Leven, Leuven

3112

Tauranga Hospital, Tauranga

3204

Waikato Hospital, Hamilton

4020

Royal Brisbane and Women's Hospital, Brisbane

4442

Palmerston North Hospital, Palmerston North

5000

Odense University Hospital, Odense

5065

Brian Fricker Oncology Centre, Burnside Hospital, Toorak Gardens

5465

Euromedica General Clinic, B' Oncology Clinic, Thessaloniki

6005

St John of God Subiaco Hospital, Subiaco

8011

Christchurch Hospital, Christchurch

9000

Aalborg University Hospital, Aalborg

10016

New York University Medical Center, New York

10048

National Taiwan University Hospital, Taipei

10060

Candiolo Cancer Institute - IRCCS, Candiolo

10408

National Cancer Center, Goyang-si

10449

Mackay Memorial Hospital, Taipei

11042

Northwell Health Monter Cancer Center, Lake Success

11217

Taipei Veterans General Hospital, Taipei

11407

Hospital de Jerez, Jerez de la Frontera

11490

Tri-Service General Hospital, Taipei

11528

Alexandra Hospital, Athens

12002

Consorcio Hospitalario Provincial Castellon, Castillón

12008

Women's Cancer Care Associates, Albany

12462

Attikon General University Hospital, Chaïdári

University Hospital Attikon, Chaïdári

13100

Ziv Medical Center, Safed

13496

CHA Bundang Medical Center, Seongnam-si

13620

Seoul National University Bundang Hospital, Seongnam-si

13790

Broome Oncology, LLC, Johnson City

15213

UPMC Magee-Womens Hospital, Pittsburgh

19090

Abington Memorial Hospital, Willow Grove

19104

University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University, Philadelphia

21287

SKCCC at Johns Hopkins, Baltimore

21565

Gachon University Gil Medical Center, Incheon

22060

Far Eastern Memorial Hospital, New Taipei City

23502

Virginia Oncology Associates, Norfolk

26335

General Hospital of Patras, Pátrai

27707

University of North Carolina, Chapel Hill

28222

Hospital Universitario Puerta de Hierro - Majadahonda, Madrid

30120

Hospital Virgen de la Arrixaca, El Palmar

30342

Northside Hospital, Atlanta

30912

Augusta University, Augusta

32207

MD Anderson Cancer Center-Baptist, Jacksonville

32804

Florida Hospital, Orlando

33011

Hospital Universitario Central de Asturias, Oviedo

33081

Centro di Riferimento Oncologico, CRO-IRCCS, Aviano

33176

Baptist Health Medical Group Oncology, LLC, Miami

33305

Chang Gung Medical Foundation- Linkou Branch, Taoyuan District

33905

Florida Gynecologic Oncology, Fort Myers

36100

Ospedale San Bortolo, Vicenza

40241

Norton Cancer Institute, Louisville

40536

University of Kentucky, Lexington

40705

Taichung Veterans General Hospital, Taichung

41014

Hospital Nuestra Señora de Valme, Seville

43210

The Ohio State University, Columbus

44106

Cleveland Clinic, Cleveland

44907

MD Anderson Cancer Center - Ohio Health, Columbus

45030

Celal Bayar University Faculty of Medicine, Manisa

45221

University of Cincinnati, Cincinnati

45242

Oncology Hematology Care, Inc, Cincinnati

46250

Community Health Network, Indianapolis

48013

Hospital Universitario Basurto, Bilbao

48201

Karmanos Cancer Institute, Detroit

52242

University of Iowa Hospitals, Iowa City

53226

Froedtert and Medical College of Wisconsin, Milwaukee

55416

Metro Minnesota Community Oncology Research Consortium, Saint Louis Park

57105

Avera Gynecologic Oncology, Sioux Falls

60521

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

60612

Rush University Medical Center, Chicago

62769

Ferrell-Duncan Clinic, Springfield

63110

Washington University School of Medicine, St Louis

65653

Masaryk Memorial Cancer Institute, Brno

66205

University of Kansas Cancer Center, Westwood

70121

Ochsner Medical Center, New Orleans

70210

Kuopio University Hospital, Kuopio

73104

University of Oklahoma Health Science Center, Oklahoma City

74146

Oklahoma Cancer Specialists and Research Institute, Tulsa

75231

Texas Oncology - Dallas Presbyterian Hospital, Dallas

76022

Texas Oncology - Bedford, Bedford

76104

Texas Oncology - Fort Worth, Fort Worth

77030

Memorial Hermann, Houston

University of Texas MD Anderson Cancer Center, Houston

77380

Texas Oncology - The Woodlands, Gynecologic Oncology, The Woodlands

78240

Texas Oncology - San Antonio Medical Center, San Antonio

78731

Texas Oncology - Austin Central, Austin

80045

University of Colorado Cancer Center, Aurora

80131

IRCCS Instituto Nazionale Tumori, Napoli

80228

Rocky Mountain Cancer Centers, Lakewood

81362

Kaohsiung Veterans General Hospital, Kaohsiung City

84112

Huntsman Cancer Institute, Salt Lake City

85016

Arizona Oncology Associates, PC - HAL, Phoenix

85711

Arizona Oncology Associates, PC - HOPE, Tucson

85724

The University of Arizona Cancer Center, Tucson

89169

Women's Cancer Center of Nevada, Las Vegas

90095

UCLA Women's Health Clinical Research Unit, Los Angeles

94520

John Muir Clinical Research Center, Concord

94589

Kaiser Permanente Northern California, San Francisco

95122

Arnas Garibaldi, Catania

97210

LMG Gynecologic Oncology, Portland

97225

Northwest Cancer Specialists, P.C., Portland

97401

Oncology Associates of Oregon, P.C., Eugene

119082

National University Hospital, Singapore

163045

Arkhangelsk Clinical Oncological Dispensary, Arkhangelsk

194356

Limited Liability Company MedPomosch, Saint Petersburg

197022

FSBEI HE I.P. Pavlov SPbSMU MoH Russia, Saint Petersburg

197758

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

198255

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

200347

Centrul de Oncologie Sf.Nectarie, Craiova

300239

ONCOMED Timisoara, Timișoara

354057

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

357502

SBHI SR Pyatigorsk Interdistrict Oncology Dispensary, Pyatigorsk

400641

S.C. Medisprof S.R.L., Cluj-Napoca

410469

"Spitalul Clinic Municipal Dr. Gavril Curteanu", Oradea

430032

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

644013

BHI of Omsk Region Clinical Oncology Dispensary, Omsk

700489

Institutul Regional de Oncologie Iasi, Iași

720237

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

2210001

Galilee Medical Center, Nahariya

4428164

Meir Medical Center, Kfar Saba

5265601

Sheba Medical Center, Ramat Gan

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

06520

Yale University, New Haven

04074

Maine Medical Center, Scarborough

02114

Massachusetts General Hospital, Boston

08103

MD Anderson Cancer Center at Cooper, Camden

07932

Summit Medical Group, Florham Park

T2N 1N4

Alberta Health Services - University of Calgary, Calgary

T6G 2B7

Alberta Health Services and The University of Alberta, Edmonton

V2S 0C2

BC Cancer - Abbotsford, Abbotsford

V1Y 5L3

BC Cancer - Kelowna, Kelowna

V3V 1Z2

BC Cancer - Surrey, Surrey

R3E 0V9

CancerCare Manitoba, Winnipeg

B3H 2Y9

Nsha-Qeii Hsc, Halifax

LbV 5C2

Juravinski Cancer Center, Hamilton

N6A 5W9

London Health Sciences Center, London

K1H 8L6

Ottawa Hospital Cancer Centre, Ottawa

H2X 0C2

Centre Hospitalier de l'Université de Montreal, Montreal

H4A 3J1

McGill University Health Center, Montreal

J1H 5N4

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

Unknown

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

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

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

Bon Secours Hospital, Cork

Shaare Zedek Medical Oncology, Jerusalem

University G, D'Annunuzio-Chieti, Chieti

University of Tsukuba Hospital, Tsukuba

Yokohama City University Hospital, Yokohama

Iwate Medical University, Morioka

National Defense Medical College Hospital, Tokorozawa

Keio University Hospital, Shinjuku-Ku

The Cancer Institute Hospital of JFCR, Koto-Ku

Kagawa Prefectural Central Hospital, Takamatsu

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

University Hospital of Bialystok, Bialystok

Pomeranian Medical University, Szczecin

Oncopremium Team, Baia Mare

SC Quantum Medical Center SRL, Bucharest

Instiute of Oncology - Medical Oncology, Cluj-Napoca

S.C Oncolab S.R.L, Craiova

Spital Municipal Ploiesti, Ploieşti

Orenburg Regional Clinical Oncological Dispensary, Orenburg

1st Medical University, Saint Petersburg

National Cancer Center Singapore, Singapore

SoonChunHyang University Cheonan Hospital, Cheonan

Korea University Guro Hospital, Seoul

Ajou University Hospital, Suwon

Onkologiska Kliniken, Linköping

Onkologiska Kliniken, Lund

Karolinska Universitetssjukhuset, Stockholm

Hualien Tzu Chi Hospital, Hualien City

China Medical University Hospital, Taichung

Chi Mei Hospital, Liouying (CMHLY), Tainan City

Chi Mei Medical Center (CMMC), Tainan City

Taipei Medical University Hospital, Taipei

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

Baskent University Hospital, Yüreğir

T12 DC4A

Cork University Hospital, Cork

V94 F858

University Hospital Limerick, Limerick

X91 ER8E

University Hospital Waterford, Waterford

00161

Azienda Ospedaliera Universitaria Policlinico Umberto I, Roma

00168

Policlinico Agostino Gemelli, Roma

00186

Ospedale S. Giovanni Calibita Fatebenefratelli, Roma

277-8577

National Cancer Center Hospital East, Kashiwa

830-0011

Kurume University Hospital, Kurume

371-8511

Gunma University Hospital, Maebashi

373-8550

Gunma Prefectural Cancer Center, Ota-shi

730-0844,

Hiroshima City Hiroshima Citizens Hospital, Naka

673-0021

Hyogo Cancer Center, Akashi

211-8533

Nippon Medical School Musashikosugi Hospital, Kawasaki-shi

241-8515

Kanagawa Cancer Center, Yokohama

541-8567

Osaka International Cancer Institute, Chuo

589-8511

Kindai University Hospital, Ōsaka-sayama

350-1298

Saitama Medical University International Medical Center, Hidaka

362-0806

Saitama Cancer Center, Saitama

104-0045

National Cancer Center Hospital, Tokyo

20-081

Bialostockie Centrum Onkologii Oddzial Onkologii Ginekologicznej, Bialystok

Medical University of Lublin, Lublin

81-519

Szpitale Pomorskie sp zoo, Gdynia

61-866

Wielkopolskie Centrum Onkologii, Poznan

01812

Korea Cancer Center Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05030

Konkuk University Medical Center, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08035

Vall d'Hebron Institute of Oncology, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

07198

Hospital Son Llatzer, Palma de Mallorca

CT1 3NG

East Kent Hospitals University NHS Foundation trust Medical Oncology, Canterbury

NN1 5BD

Northampton General Hospital, Cliftonville

BN2 3EH

Royal Sussex County Hospital, Brighton

BS2 8HW

Bristol Cancer Institute Medical Oncology, Bristol

CB2 0QQ

Addenbrookes Hospital, Cambridge

EH4 2XU

Western General Hospital, Edinburgh

LA1 4RP

University Hospitals of Morecambe Bay NHS Foundation Trust, Lancaster

LS9 7TF

St. James University Hospital, Leeds

EC1A 7BE

Barts and the London NHS Trust, London

NW1 2PG

University of College London Hospital, London

SE1 9RT

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

SW3 6JJ

The Royal Marsden NHS Foundation Trust, London

W12 0HS

Imperial College London, London

TS4 3BW

The James Cook University Hospital, Middlesbrough

BH15 2JB

Poole Hospital NHS Foundation Trust, Poole

SA2 8QA

South West Wales Cancer Centre - Singleton Hospital, Swansea

TA1 5DA

Musgrove Park Hospital, Taunton

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Gynecologic Oncology Group

NETWORK

collaborator

European Network of Gynaecological Oncological Trial Groups (ENGOT)

OTHER

collaborator

Foundation Medicine

INDUSTRY

lead

pharmaand GmbH

INDUSTRY