Ovarian Cancer Clinical Trial

Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036)

Summary

The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.

The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants.

View Full Description

Full Description

Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin/paclitaxel*, participants will be randomly assigned in to one of three treatment arms:

Pembrolizumab + Olaparib,
Pembrolizumab + Placebo for Olaparib

Placebo for Pembrolizumab + Placebo for Olaparib

At Investigator's discretion and prior to participant randomization, one of the following carboplatin/paclitaxel regimens is to be selected:

up to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg/m^2 on Day 1 of each 3-week cycle
up to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle; or
up to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle.

Docetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg/m^2 Q3W plus carboplatin AUC 5 Q3W.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer
Has just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery
Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting
Candidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25
Is able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1
Female participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Has adequate organ function

Exclusion Criteria:

Has mucinous, germ cell, or borderline tumor of the ovary
Has a known or suspected deleterious mutation (germline or somatic) in either BRCA1 or BRCA2
Has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis
Has either myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
Has a known additional malignancy that is progressing or has required active treatment in the last 3 years Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. ductal carcinoma in situ, cervical carcinoma in situ) that has undergone potentially curative therapy are not excluded.
Has ongoing Grade 3 or Grade 4 toxicity, excluding alopecia, following chemotherapy administered during the lead-in period
Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with brain metastases may participate provided they were previously treated (except with chemotherapy) and are radiologically stable, clinically stable, and no steroids were used for the management of symptoms related to brain metastases within 14 days prior to randomization. Stable brain metastases should be established prior to the first dose of study medication lead-in chemotherapy
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
Has a known history of active tuberculosis (TB; Bacillus Tuberculosis)
Has an active infection requiring systemic therapy
Has received colony-stimulating factors (eg, granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 4 weeks prior to receiving chemotherapy during the lead-in period
Is considered to be of poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection
Has had surgery to treat borderline tumors, early stage EOC, or early stage fallopian tube cancer <6 months prior to screening
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Testing for hepatitis B or hepatitis C is required at screening only if mandated by local health authority. Note: Participants with a history of hepatitis B but who are HBsAg negative are eligible for the study
Is either unable to swallow orally administered medication or has a gastrointestinal (GI) disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, malabsorption)
Has uncontrolled hypertension
Has current, clinically relevant bowel obstruction (including sub-occlusive disease), abdominal fistula or GI perforation, related to underlying EOC (for participants receiving bevacizumab)
Has a history of hemorrhage, hemoptysis or active GI bleeding within 6 months prior to randomization (for participants receiving bevacizumab)
Is a WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of chemotherapy in the lead-in period and within 72 hours prior to Day 1 of Cycle 1, is pregnant or breastfeeding, or is expecting to conceive children within the projected duration of the study, starting with screening through 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy
Has received prior treatment for any stage of OC, including radiation or systemic anti-cancer therapy (e.g. chemotherapy, hormonal therapy, immunotherapy, investigational therapy)
Has received prior therapy with an anti-Programmed Cell Death-1 (anti-PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T lymphocyte antigen-4 [CTLA-4], OX 40, CD137)
Has received prior therapy with either olaparib or any other poly(adenosine-ribose) polymerase (PARP) inhibitor
Has intraperitoneal chemotherapy planned or has been administered as first-line therapy
Has received a live vaccine within 30 days prior to the first dose of study treatment on Day 1 of Cycle 1
Has severe hypersensitivity (≥Grade 3) to pembrolizumab, olaparib, carboplatin, paclitaxel or bevacizumab (if using) and/or any of their excipients
Is currently receiving either strong (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
Is currently receiving either strong (e.g. phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine, and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study
Has received whole blood transfusions in the last 120 days prior to randomization
Is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks (28 days) of starting chemotherapy in the Lead-in Period
Has resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions or participant has congenital long QT syndrome
Has had an allogenic tissue/solid organ transplant, has received previous allogenic bone-marrow transplant, or has received double umbilical cord transplantation
Either has had major surgery within 3 weeks of randomization or has not recovered from any effects of any major surgery

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

1367

Study ID:

NCT03740165

Recruitment Status:

Active, not recruiting

Sponsor:

Merck Sharp & Dohme LLC

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 224 Locations for this study

See Locations Near You

University of Alabama at Birmingham (UAB) ( Site 0036)
Birmingham Alabama, 35233, United States
University of Arizona Cancer Center ( Site 0074)
Tucson Arizona, 85719, United States
Disney Family Cancer Center ( Site 0042)
Burbank California, 91505, United States
Kaiser Permanente Oncology Clinical Trial -Oakland ( Site 0077)
Oakland California, 94611, United States
Kaiser Permanente Oncology Clinical Trials-Roseville ( Site 0084)
Roseville California, 95661, United States
Kaiser Permanente Oncology Clinical Trials-Sacramento ( Site 0083)
Sacramento California, 95814, United States
Kaiser Permanente Oncology Clinical Trial - San Francisco ( Site 0078)
San Francisco California, 94115, United States
Kaiser Permanente Oncology Clinical Trial - Santa Clara ( Site 0079)
Santa Clara California, 95051, United States
Kaiser Permanente N. CA Regional Oncology Clinical Trials ( Site 0008)
Vallejo California, 94589, United States
Kaiser Permanente Oncology Clinical Trial - Walnut Creek ( Site 0080)
Walnut Creek California, 94596, United States
Smilow Cancer Center at Yale-New Haven ( Site 0057)
New Haven Connecticut, 06511, United States
Sarasota Memorial Hospital ( Site 0023)
Sarasota Florida, 34239, United States
Emory School of Medicine ( Site 0053)
Atlanta Georgia, 30322, United States
Northeast Georgia Medical Center ( Site 0029)
Gainesville Georgia, 30501, United States
Memorial Health University Medical Center ( Site 0011)
Savannah Georgia, 31404, United States
Rush University Medical Center ( Site 0019)
Chicago Illinois, 60612, United States
University of Chicago ( Site 0049)
Chicago Illinois, 60637, United States
Dr. Sudarshan K. Sharma, LTD ( Site 0061)
Hinsdale Illinois, 60521, United States
Saint Vincent Hospital and Health Center ( Site 0012)
Indianapolis Indiana, 46260, United States
University of Iowa Hospital and Clinics ( Site 0005)
Iowa City Iowa, 52242, United States
University of Kentucky ( Site 0045)
Lexington Kentucky, 40536, United States
Weinberg Cancer Institute at Franklin Square ( Site 0035)
Baltimore Maryland, 21237, United States
Saint Dominic - Jackson Memorial Hospital ( Site 0072)
Jackson Mississippi, 39216, United States
Washington University - School of Medicine ( Site 0062)
Saint Louis Missouri, 63110, United States
Nebraska Methodist Hospital ( Site 0063)
Omaha Nebraska, 68114, United States
Dartmouth Hitchcock Medical Center ( Site 0024)
Lebanon New Hampshire, 03756, United States
MD Anderson Cancer Center at Cooper ( Site 0067)
Camden New Jersey, 08103, United States
Holy Name Medical Center ( Site 0037)
Teaneck New Jersey, 07666, United States
Northwell Health- Monter Cancer Center ( Site 0075)
Lake Success New York, 11042, United States
Sanford Roger Maris Cancer Center ( Site 0082)
Fargo North Dakota, 58122, United States
Miami Valley Hospital [Dayton, OH] ( Site 0073)
Centerville Ohio, 45459, United States
Oncology/Hematology Care Clinical Trials, LLC ( Site 8001)
Cincinnati Ohio, 45242, United States
The Bing Cancer Center ( Site 0044)
Columbus Ohio, 43214, United States
OSU Wexner Medical Center ( Site 0076)
Hilliard Ohio, 43026, United States
Women and Infants Hospital [Providence, RI] ( Site 0039)
Providence Rhode Island, 02905, United States
Sanford Gynecology Oncology ( Site 0004)
Sioux Falls South Dakota, 57104, United States
Texas Oncology, P.A. - Bedford ( Site 8005)
Bedford Texas, 76022, United States
Texas Oncology-Dallas Presbyterian Hospital ( Site 8004)
Dallas Texas, 75231, United States
Parkland Hospital ( Site 0081)
Dallas Texas, 75235, United States
UT Southwestern Medical Center ( Site 0046)
Dallas Texas, 75390, United States
Texas Oncology, P.A. Texas Oncology-Tyler ( Site 8006)
Tyler Texas, 75702, United States
Virginia Cancer Specialists, PC ( Site 8003)
Gainesville Virginia, 20155, United States
MEDICAL COLLEGE OF WISCONSIN ( Site 0064)
Milwaukee Wisconsin, 53226, United States
St George Hospital ( Site 2207)
Kogarah New South Wales, 2217, Australia
Cairns and Hinterland Hospital and Health Service ( Site 2201)
Cairns Queensland, 4870, Australia
Ballarat Health Services ( Site 2202)
Ballarat Victoria, 3350, Australia
Monash Health ( Site 2204)
Clayton Victoria, 3168, Australia
Sunshine Hospital. ( Site 2205)
St Albans Victoria, 3021, Australia
Imelda Ziekenhuis Bonheiden ( Site 0301)
Bonheiden Antwerpen, 1932, Belgium
UZ Leuven Campus Gasthuisberg ( Site 0306)
Leuven Antwerpen, 3000, Belgium
Cliniques Universitaires Saint-Luc ( Site 0312)
Brussels Bruxelles-Capitale, Region De, 1200, Belgium
Grand Hopital de Charleroi ( Site 0302)
Charleroi Hainaut, 6000, Belgium
CHU de Liege ( Site 0310)
Liège Liege, 4000, Belgium
Jessa Ziekenhuis ( Site 0309)
Hasselt Limburg, 3500, Belgium
Centre Hospitalier de l'Ardenne ( Site 0303)
Libramont Luxembourg, 6800, Belgium
AZ Maria Middelares Gent ( Site 0300)
Gent Oost-Vlaanderen, 9000, Belgium
UZ Gent ( Site 0307)
Gent Oost-Vlaanderen, 9000, Belgium
Instituto do Cancer do Ceara ( Site 2707)
Fortaleza Ceara, 60430, Brazil
Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2708)
Goiania Goias, 74605, Brazil
Hospital Erasto Gaertner ( Site 2716)
Curitiba Parana, 82520, Brazil
Hospital de Caridade de Ijui ( Site 2712)
Ijui Rio Grande Do Sul, 98700, Brazil
Hospital Bruno Born ( Site 2704)
Lajeado Rio Grande Do Sul, 95900, Brazil
Hospital Nossa Senhora Da Conceicao ( Site 2703)
Porto Alegre Rio Grande Do Sul, 91350, Brazil
Instituto Nacional de Cancer Hospital do Cancer II ( Site 2700)
Rio de Janeiro , 20220, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2714)
Sao Paulo , 01246, Brazil
Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706)
Sao Paulo , 01317, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2710)
Sao Paulo , 01321, Brazil
Tom Baker Cancer Centre ( Site 0200)
Calgary Alberta, T2N 4, Canada
Kingston Health Sciences Centre ( Site 0207)
Kingston Ontario, K7L 2, Canada
The Credit Valley Hospital ( Site 0206)
Mississauga Ontario, L5M 2, Canada
Princess Margaret Hospital.. ( Site 0202)
Toronto Ontario, M5G 2, Canada
CIUSSS du Saguenay-Lac-St-Jean ( Site 0218)
Chicoutimi Quebec, G7H 5, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0219)
Montreal Quebec, H1T 2, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0208)
Montreal Quebec, H2X 0, Canada
Royal Victoria Hospital McGill University Health Centre ( Site 0211)
Montreal Quebec, H4A 3, Canada
Centro Investigación del Cáncer James Lind ( Site 2810)
Temuco Araucania, 47800, Chile
Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 2808)
Temuco Araucania, 48102, Chile
Fundacion Arturo Lopez Perez FALP ( Site 2800)
Santiago Region M. De Santiago, 75009, Chile
Sociedad Oncovida S.A. ( Site 2807)
Santiago Region M. De Santiago, 75100, Chile
Iram Cancer Research ( Site 2809)
Santiago Region M. De Santiago, 76303, Chile
Pontificia Universidad Catolica de Chile ( Site 2805)
Santiago Region M. De Santiago, 83300, Chile
Oncocentro ( Site 2801)
Vina del Mar Valparaiso, 25205, Chile
Centro Oncologico Antofagasta ( Site 2804)
Antofagasta , 12400, Chile
Biomelab S A S ( Site 2900)
Barranquilla Atlantico, 08000, Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2913)
Valledupar Cesar, 20000, Colombia
Oncomedica S.A. ( Site 2911)
Monteria Cordoba, 23000, Colombia
Instituto Nacional de Cancerologia E.S.E ( Site 2910)
Bogota Distrito Capital De Bogota, 11032, Colombia
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2912)
Bogota Distrito Capital De Bogota, 11132, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 2909)
Cali Valle Del Cauca, 76004, Colombia
Hemato Oncologos S.A. ( Site 2906)
Cali Valle Del Cauca, 76004, Colombia
Fakultni nemocnice Brno ( Site 0404)
Brno Brno-mesto, 602 0, Czechia
Fakultni nemocnice Ostrava ( Site 0403)
Ostrava-Poruba Moravskoslezsky Kraj, 708 5, Czechia
Vseobecna fakultni nemocnice v Praze ( Site 0400)
Praha Praha, Hlavni Mesto, 120 0, Czechia
Nemocnice Na Bulovce ( Site 0401)
Praha Praha, Hlavni Mesto, 180 8, Czechia
Fakultni nemocnice Olomouc ( Site 0402)
Olomouc , 779 0, Czechia
Hopital Prive Jean Mermoz ( Site 0607)
Lyon Auvergne, 69008, France
Centre Paul Strauss ( Site 0615)
Strasbourg Bas-Rhin, 67065, France
Hopital de la Timone ( Site 0617)
Marseille Bouches-du-Rhone, 13005, France
CHU de Brest -Site Hopital Morvan ( Site 0616)
Brest Bretagne, 29200, France
Institut de Cancerologie du Gard - CHU Caremeau ( Site 0610)
Nimes Gard, 30029, France
Institut de Cancerologie Lucien Neuwirth ( Site 0613)
Saint-Priest-en-Jarez Loire, 42270, France
Centre D Oncologie de Gentilly ( Site 0609)
Nancy Meurthe-et-Moselle, 54100, France
Institut Gustave Roussy ( Site 0600)
Villejuif Val-de-Marne, 94800, France
Hopital Tenon ( Site 0612)
Paris , 75020, France
Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0707)
Stuttgart Baden-Wurttemberg, 70199, Germany
Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0710)
Muenchen Bayern, 72074, Germany
Uniklinik RWTH Aachen ( Site 0718)
Aachen Nordrhein-Westfalen, 52074, Germany
Gynaekologisches Zentrum ( Site 0712)
Bonn Nordrhein-Westfalen, 53111, Germany
Klinikum Dortmund gGmbH ( Site 0717)
Dortmund Nordrhein-Westfalen, 44137, Germany
Universitaetsklinikum Duesseldorf ( Site 0704)
Duesseldorf Nordrhein-Westfalen, 40225, Germany
HELIOS Klinikum Krefeld ( Site 0715)
Krefeld Nordrhein-Westfalen, 47805, Germany
Universitaetsklinikum Muenster ( Site 0720)
Muenster Nordrhein-Westfalen, 48149, Germany
Caritas Klinikum Saarbruecken St. Theresia ( Site 0702)
Saarbruecken Saarland, 66113, Germany
Klinikum Chemnitz gGmbH ( Site 0711)
Chemnitz Sachsen, 09116, Germany
Staedtisches Krankenhaus Kiel GmbH ( Site 0709)
Kiel Schleswig-Holstein, 24116, Germany
Charite Campus Virchow-Klinikum - CVK ( Site 0700)
Berlin , 13353, Germany
Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 0805)
Pecs Baranya, 7624, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz ( Site 0802)
Miskolc Borsod-Abauj-Zemplen, 1051, Hungary
Orszagos Onkologiai Intezet ( Site 0800)
Budapest , 1122, Hungary
Uzsoki Utcai Korhaz ( Site 0803)
Budapest , 1145, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 0801)
Debrecen , 4032, Hungary
Soroka Medical Center ( Site 1006)
Beer-Sheva , 84101, Israel
Hillel Yaffe Medical Center ( Site 1011)
Hadera , 38101, Israel
Carmel Medical Center ( Site 1007)
Haifa , 34362, Israel
Rambam Medical Center ( Site 1002)
Haifa , 35254, Israel
Edith Wolfson Medical Center ( Site 1003)
Holon , 58220, Israel
Shaare Zedek Medical Center ( Site 1005)
Jerusalem , 91031, Israel
Rabin Medical Center ( Site 1004)
Petah Tikva , 49414, Israel
Chaim Sheba Medical Center ( Site 1000)
Ramat Gan , 52620, Israel
Sourasky Medical Center ( Site 1001)
Tel Aviv , 64239, Israel
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1108)
Bari Abruzzo, 70124, Italy
Istituto Europeo di Oncologia ( Site 1100)
Milano Lombardia, 20141, Italy
A.O.U. Citta della Salute e della Scienza di Torino ( Site 1104)
Torino Piemonte, 10126, Italy
Istituto Oncologico Veneto IRCCS ( Site 1113)
Padova Veneto, 35128, Italy
Sacro Cuore di Gesu Fatebenefratelli ( Site 1112)
Benevento , 82100, Italy
Ospedale Cannizzaro ( Site 1110)
Catania , 95126, Italy
ASST Lecco. Ospedale A. Manzoni ( Site 1101)
Lecco , 23900, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1115)
Milano , 20133, Italy
A.O.U. Federico II di Napoli ( Site 1107)
Napoli , 80131, Italy
Azienda Ospedaliera Policlinico Umberto I ( Site 1111)
Roma , 00161, Italy
Policlinico Universitario Gemelli ( Site 1105)
Roma , 00168, Italy
Presidio Ospedaliero Santa Chiara ( Site 1109)
Trento , 38122, Italy
A.O. Univ. S. M. della Misericordia ( Site 1114)
Udine , 33100, Italy
National Cancer Center Hospital East ( Site 2602)
Kashiwa Chiba, 277-8, Japan
National Hospital Organization Shikoku Cancer Center ( Site 2601)
Matsuyama Ehime, 791-0, Japan
Ehime University Hospital ( Site 2600)
Toon Ehime, 791-0, Japan
Gunma Prefectural Cancer Center ( Site 2609)
Ota Gunma, 373-8, Japan
Hokkaido University Hospital ( Site 2607)
Sapporo Hokkaido, 060-8, Japan
Iwate Medical University Hospital ( Site 2606)
Shiwa-gun Iwate, 028-3, Japan
St. Marianna University School of Medicine Hospital ( Site 2613)
Kawasaki Kanagawa, 216-8, Japan
University of the Ryukyus Hospital ( Site 2616)
Nakagami-gun Okinawa, 903-0, Japan
Saitama Medical University International Medical Center ( Site 2604)
Hidaka Saitama, 350-1, Japan
Saitama Cancer Center ( Site 2614)
Kitaadachi-gun Saitama, 362-0, Japan
National Defense Medical College Hospital ( Site 2608)
Tokorozawa Saitama, 359-8, Japan
Kyorin University Hospital ( Site 2610)
Mitaka Tokyo, 181-8, Japan
Kagoshima City Hospital ( Site 2612)
Kagoshima , 890-8, Japan
Niigata Cancer Center Hospital ( Site 2618)
Niigata , 951-8, Japan
Osaka International Cancer Institute ( Site 2617)
Osaka , 541-8, Japan
National Cancer Center Hospital ( Site 2605)
Tokyo , 104-0, Japan
Seoul National University Bundang Hospital ( Site 2404)
Seongnam-si Kyonggi-do, 13620, Korea, Republic of
Seoul National University Hospital ( Site 2403)
Seoul , 03080, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 2400)
Seoul , 03722, Korea, Republic of
Asan Medical Center ( Site 2402)
Seoul , 05505, Korea, Republic of
Samsung Medical Center ( Site 2401)
Seoul , 06351, Korea, Republic of
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
Warszawa Mazowieckie, 02-78, Poland
Bialostockie Centrum Onkologii ( Site 1412)
Bialystok Podlaskie, 15-02, Poland
Szpitale Pomorskie Sp. z o.o. ( Site 1407)
Gdynia Pomorskie, 81-51, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1406)
Gliwice Slaskie, 44-10, Poland
Swietokrzyskie Centrum Onkologii SPZOZ ( Site 1410)
Kielce Swietokrzyskie, 25-73, Poland
Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna
Poznan Wielkopolskie, 61-84, Poland
Arkhangelsk Clinical Oncological Dispensary ( Site 1508)
Arkhangelsk Arkhangel Skaya Oblast, 16304, Russian Federation
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507)
Ufa Baskortostan, Respublika, 45005, Russian Federation
A. Tsyb Medical Radiological Research Center ( Site 1513)
Obninsk Kaluzskaja Oblast, 24903, Russian Federation
FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1500)
Moscow Moskva, 11547, Russian Federation
FSCC of Special Types of Med. Care and Technologies ( Site 1503)
Moscow Moskva, 11568, Russian Federation
Medical Rehabilitation Center ( Site 1502)
Moscow Moskva, 12536, Russian Federation
City Clinical Oncology Center ( Site 1505)
Saint Petersburg Sankt-Peterburg, 19825, Russian Federation
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1504)
Saint-Petersburg Sankt-Peterburg, 19775, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1509)
Kazan Tatarstan, Respublika, 42002, Russian Federation
Cancer Care Langenhoven Drive Oncology Centre ( Site 1701)
Port Elizabeth Eastern Cape, 6045, South Africa
Groote Schuur Hospital ( Site 1704)
Cape Town Gauteng, 7925, South Africa
Wits Clinical Research ( Site 1702)
Johannesburg Gauteng, 2193, South Africa
Department of Medical Oncology ( Site 1703)
Pretoria Gauteng, 0002, South Africa
Curo Oncology ( Site 1710)
Pretoria Gauteng, 0031, South Africa
Wilgers Oncology Centre ( Site 1705)
Pretoria Gauteng, 0081, South Africa
Little Company of Mary Hospital ( Site 1700)
Pretoria Gauteng, 0181, South Africa
Sandton Oncology Medical Group PTY LTD ( Site 1712)
Sandton Gauteng, 2196, South Africa
The Oncology Centre ( Site 1709)
Durban Kwazulu-Natal, 4091, South Africa
Cancercare ( Site 1706)
Cape Town Western Cape, 7700, South Africa
Outeniqua Cancercare Oncology Unit ( Site 1708)
George Western Cape, 6530, South Africa
Cape Town Oncology Trials Pty Ltd ( Site 1707)
Kraaifontein Western Cape, 7570, South Africa
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1603)
Hospitalet de Llobregat Barcelona, 08909, Spain
Xarxa Assistencial Universitaria Manresa ( Site 1605)
Manresa Barcelona, 08243, Spain
Hospital de Terrassa ( Site 1606)
Terrassa Barcelona, 08227, Spain
Hospital Universitario de Donostia ( Site 1602)
Donostia Gipuzkoa, 20014, Spain
Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1608)
A Coruna La Coruna, 15006, Spain
Instituto Valenciano de Oncologia ( Site 1601)
Valencia Valenciana, Comunitat, 46009, Spain
Hospital General Universitario de Valencia ( Site 1610)
Valencia Valenciana, Comunitat, 46014, Spain
Hospital Provincial San Pedro de Alcantara ( Site 1607)
Caceres , 10003, Spain
Hospital Universitario Lucus Augusti ( Site 1609)
Lugo , 27003, Spain
Clinica Universitaria de Navarra ( Site 1600)
Madrid , 28027, Spain
Hospital Universitario Virgen del Rocio ( Site 1604)
Sevilla , 41013, Spain
Changhua Christian Hospital ( Site 2507)
Changhua , 50006, Taiwan
China Medical University Hospital ( Site 2506)
Taichung , 40447, Taiwan
Taichung Veterans General Hospital ( Site 2510)
Taichung , 40705, Taiwan
National Cheng Kung University Hospital ( Site 2508)
Tainan , 704, Taiwan
National Taiwan University Hospital ( Site 2502)
Taipei , 10002, Taiwan
MacKay Memorial Hospital ( Site 2500)
Taipei , 10449, Taiwan
Taipei Veterans General Hospital ( Site 2503)
Taipei , 11217, Taiwan
Linkou Chang Gung Memorial Hospital ( Site 2501)
Taoyuan , 333, Taiwan
Istanbul Acibadem University Atakent Hospital ( Site 1902)
Kucukcekmece Istanbul, 34303, Turkey
Etlik Zubeyde Hanim Kadin Hastaliklari Egitim ve Arastirma Hastanesi ( Site 1903)
Ankara , 06050, Turkey
Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 1905)
Ankara , 06590, Turkey
Akdeniz Universitesi Tıp Fakultesi ( Site 1901)
Antalya , 07070, Turkey
Uludag Universitesi Tip Fakultesi ( Site 1904)
Bursa , 16059, Turkey
Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1900)
Istanbul , 34093, Turkey
Bakirkoy Sadi Konuk Egitim ve Arastirma Hastanesi ( Site 1907)
Istanbul , 34147, Turkey
Medipol Universite Hastanesi ( Site 1909)
Istanbul , 34214, Turkey
Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 1906)
Sakarya , 54290, Turkey
MI Precarpathian Clinical Oncology Center ( Site 2181)
Ivano-Frankivsk Ivano-Frankivska Oblast, 76018, Ukraine
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2180)
Kharkiv Kharkivska Oblast, 61024, Ukraine
Municipal non-profit Enterprise Khmelnytskyi Regional Antitu-Gynecological Oncology department, Poli
Khmelnytskyi Khmelnytska Oblast, 29009, Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2170)
Lviv Lvivska Oblast, 79031, Ukraine
MI Odessa Regional Oncological Centre ( Site 2121)
Odesa Odeska Oblast, 65055, Ukraine
RMI - Sumy Regional Clinical Oncology Dispensary ( Site 2191)
Sumy Sumska Oblast, 40022, Ukraine
Central City Clinical Hospital ( Site 2150)
Uzhgorod Zakarpatska Oblast, 88000, Ukraine
Kyiv City Clinical Oncological Center ( Site 2140)
Kyiv , 03115, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

1367

Study ID:

NCT03740165

Recruitment Status:

Active, not recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.