Clinical trial NCT05116189: Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65)
Official title: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96/ENGOT-ov65)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Ovarian Cancer
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2021-11-10
Enrollment: 616
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score \[CPS\] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants.


Eligibility criteria: Inclusion Criteria:

* Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
* Has received 1 or 2 prior lines of systemic therapy for ovarian cancer (OC), including at least 1 prior platinum-based therapy. Participants may have received a prior poly (ADP-ribose) polymerase inhibitor (PARPi), anti-PD-1/anti-PD-L1 therapy, bevacizumab, or hormonal therapy; these will not be considered a separate line of therapy. Any chemotherapy regimen change due to toxicity in the absence of disease progression will be considered part of the same line of therapy.
* Has provided documented informed consent for the study.
* Has radiographic evidence of disease progression within 6 months (180 days) after the last dose of platinum-based chemotherapy for OC (i.e., platinum-resistant disease).
* Is a candidate for paclitaxel chemotherapy (and bevacizumab, if using).
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before randomization.
* For a female participant, she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and uses a contraceptive method that is highly effective (with a failure rate of \<1% per year).
* Has radiographically evaluable disease, either measurable or nonmeasurable per RECIST 1.1, as assessed by the local site investigator.
* Archival tumor tissue sample or newly obtained core or incisional/excisional biopsy of a tumor lesion not previously irradiated has been provided.
* Have adequate organ function.

Exclusion Criteria:

* Has nonepithelial cancers, borderline tumors, mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma.
* Has primary platinum-refractory disease, defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of first-line platinum-based therapy.
* Has prior disease progression on weekly paclitaxel alone.
* Has received \>2 prior lines of systemic therapy for OC.
* Has received prior systemic anticancer therapy including investigational agents or maintenance therapy (including bevacizumab maintenance therapy), within 4 weeks before randomization.
* Has received prior radiation therapy within 2 weeks of start of study intervention.
* Has not recovered adequately from surgery and/or any complications from the surgery.
* Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor \[G-CSF\], granulocyte-macrophage colony-stimulating factor,\[GM-CSF\] or recombinant erythropoietin) within 4 weeks before randomization.
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
* Has received investigational agent or has used an investigational device within 4 weeks prior to study intervention.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has severe hypersensitivity (≥Grade 3) to pembrolizumab, paclitaxel, or bevacizumab (if using) and/or any of their excipients.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years.
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Has an active infection requiring systemic therapy.
* Has a known history of human immunodeficiency virus (HIV) infection.
* Has a known history of Hepatitis B or known active Hepatitis C virus infection.
* Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study.
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
* Participant, in the judgement of the investigator, is unlikely to comply with the study procedures, restrictions, and requirements of the study.
* Has had an allogenic tissue/solid organ transplant.

For bevacizumab treatment

* Has uncontrolled hypertension.
* Has current, clinically relevant bowel obstruction including related to underlying epithelial OC, abdominal fistula or gastrointestinal perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam.
* Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before randomization.

Primary outcomes:
measure: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator
timeFrame: Up to ~38 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to ~64 months
measure: PFS per RECIST 1.1 by Blinded Independent Central Review (BICR)
timeFrame: Up to ~38 months
measure: Number of Participants who Experience an Adverse Event (AE)
timeFrame: Up to ~64 months
measure: Number of Participants who Discontinue Study Treatment due to an AE
timeFrame: Up to ~64 months
measure: Change From Baseline in Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
timeFrame: Baseline and up to ~64 months
measure: Time to Deterioration (TTD) in the GHS/Qol Score (Items 29 and 30) Using the EORTC QLQ-C30
timeFrame: Up to ~64 months
measure: Change From Baseline in the Abdominal and Gastrointestinal (GI) Symptoms Score (Items 31 to 36) Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale
timeFrame: Baseline and up to ~64 months
measure: TTD in the Abdominal and GI Symptoms Score (Items 31 to 36) Using the EORTC QLQ-OV28 Abdominal/GI Symptom Scale
timeFrame: Up to ~64 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: HonorHealth ( Site 0041)
state: Arizona
city: Greenbrae
country: United States
facility: Marin Cancer Care ( Site 0055)
state: California
city: Monterey
country: United States
facility: Pacific Cancer Care ( Site 0028)
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center ( Site 0067)
state: California
city: New Haven
country: United States
facility: Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004)
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital ( Site 0018)
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center ( Site 0033)
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005)
state: Georgia
city: Park Ridge
country: United States
facility: Advocate Medical Group-Oncology ( Site 0049)
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center at Parkview Regional Medical Center ( Site 0027)
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Hospital and Health Care Center, Inc ( Site 0032)
state: Indiana
city: Edgewood
country: United States
facility: Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0040)
state: Kentucky
city: Shreveport
country: United States
facility: WK Physicians Network / Hematology Oncology Associates ( Site 0034)
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0015)
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School-Division of Gynecologic Oncology ( Site 0003)
state: Massachusetts
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0007)
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute ( Site 0039)
state: New York
city: New York
country: United States
facility: Columbia University Medical Center ( Site 0010)
state: New York
city: Charlotte
country: United States
facility: Novant Health Presbyterian Medical Center ( Site 0029)
state: North Carolina
city: Durham
country: United States
facility: Duke Cancer Institute ( Site 0038)
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center ( Site 0057)
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital-Oncology Clinical Trials ( Site 0009)
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center-Cancer Care Center ( Site 0047)
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center ( Site 0048)
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0024)
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Cancer Center ( Site 0064)
state: South Dakota
city: Germantown
country: United States
facility: The West Clinic, PLLC dba West Cancer Center ( Site 0058)
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology - Dallas (Presbyterian) ( Site 0065)
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - The Woodlands_Lee ( Site 0043)
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute ( Site 0019)
state: Virginia
city: Westmead
country: Australia
facility: Westmead Hospital-Department of Gynaecological Oncology ( Site 0201)
state: New South Wales
city: Brisbane
country: Australia
facility: Gallipoli Medical Research Foundation-GMRF CTU ( Site 0202)
state: Queensland
city: Melbourne
country: Australia
facility: Epworth Freemasons ( Site 0204)
state: Victoria
city: Subiaco
country: Australia
facility: St. John of God Subiaco Hospital ( Site 0203)
state: Western Australia
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet-Medicine Oncology ( Site 0302)
state: Bruxelles-Capitale, Region De
city: Gent
country: Belgium
facility: UZ Gent-Medical oncology ( Site 0301)
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven ( Site 0303)
state: Vlaams-Brabant
city: Kortrijk
country: Belgium
facility: AZ Groeninge Campus Kennedylaan-Oncology ( Site 0305)
state: West-Vlaanderen
city: Goiânia
country: Brazil
facility: Hospital Araújo Jorge ( Site 0401)
state: Goias
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0404)
state: Rio Grande Do Norte
city: Lages
country: Brazil
facility: ANIMI - Unidade de Tratamento Oncologico ( Site 0408)
state: Santa Catarina
city: São Paulo
country: Brazil
facility: BP - A Beneficencia Portuguesa de São Paulo ( Site 0403)
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0405)
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0402)
city: Calgary
country: Canada
facility: Tom Baker Cancer Center ( Site 0511)
state: Alberta
city: Abbotsford
country: Canada
facility: BC Cancer Abbotsford ( Site 0512)
state: British Columbia
city: Victoria
country: Canada
facility: BC Cancer Victoria ( Site 0513)
state: British Columbia
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre-Kingston General Hospital Si-Oncology and/or Hematology - Gynecolog
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0508)
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0501)
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital ( Site 0505)
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 0502)
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Center ( Site 0510)
state: Saskatchewan
city: Quebec
country: Canada
facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
city: Temuco
country: Chile
facility: James Lind Centro de Investigación del Cáncer ( Site 0602)
state: Araucania
city: Temuco
country: Chile
facility: CIDO SpA-Oncology ( Site 0608)
state: Araucania
city: Puerto Montt
country: Chile
facility: Clínica Puerto Montt ( Site 0601)
state: Los Lagos
city: Santiago
country: Chile
facility: Oncovida ( Site 0603)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Instituto de Radiomedicina-hemato-oncologia ( Site 0604)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Clínica Vespucio-Hemato - Ocology ( Site 0607)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0609)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill ( Site 0605)
state: Region M. De Santiago
city: Hefei
country: China
facility: Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 0709)
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer hospital ( Site 0711)
state: Beijing
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital-Gynecological center of tumor ( Site 0702)
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital ( Site 0713)
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou university second hospital ( Site 0734)
state: Gansu
city: Guangzhou
country: China
facility: Zhujiang Hospital ( Site 0739)
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated Hospital of Guangdong Medical University ( Site 0743)
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital ( Site 0717)
state: Guangxi
city: Haikou
country: China
facility: Hainan General Hospital ( Site 0736)
state: Hainan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 0718)
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital-Medical Oncology ( Site 0735)
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 0708)
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University-Gynecology ( Site 0705)
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 0704)
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University ( Site 0723)
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Maternal and Child Health Hospital-Oncology Department ( Site 0716)
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University ( Site 0710)
state: Jilin
city: Jinan
country: China
facility: Shandong Cancer Hospital-Oncology Department ( Site 0733)
state: Shandong
city: Linyi
country: China
facility: LinYi Cancer Hospital ( Site 0731)
state: Shandong
city: Shanghai
country: China
facility: Obstetrics & Gynecology Hospital of Fudan University ( Site 0715)
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center-Gynecologic Oncology Department ( Site 0701)
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 0744)
state: Shanghai
city: Chengdu
country: China
facility: West China Second University Hospital Sichuan University ( Site 0740)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Central Hosptial of Gynecology Obstetrics ( Site 0737)
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital ( Site 0720)
state: Tianjin
city: Kunming
country: China
facility: Yunnan Province Cancer Hospital-Gynecology Department ( Site 0714)
state: Yunnan
city: Hangzhou
country: China
facility: The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0741)
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0706)
state: Zhejiang
city: Medellin
country: Colombia
facility: Fundación Colombiana de Cancerología Clínica Vida ( Site 0808)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Clinica de la Costa LTDA-Clinical Research Oncology & Hematology -Pediatric ( Site 0809)
state: Atlantico
city: Bogotá
country: Colombia
facility: Clínica Universitaria Colombia ( Site 0806)
state: Distrito Capital De Bogota
city: Pereira
country: Colombia
facility: Oncologos del Occidente ( Site 0807)
state: Risaralda
city: Cali
country: Colombia
facility: Hemato Oncologos SA ( Site 0801)
state: Valle Del Cauca
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital, Syd ( Site 0901)
state: Nordjylland
city: Turku
country: Finland
facility: Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001)
state: Varsinais-Suomi
city: Brest
country: France
facility: Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi
state: Bretagne
city: Caen
country: France
facility: Centre François Baclesse-Recherche clinique ( Site 2904)
state: Calvados
city: Limoges
country: France
facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-oncologie ( Site 2907)
state: Haute-Vienne
city: Saint-Cloud
country: France
facility: Institut Curie - site Saint-Cloud ( Site 2909)
state: Hauts-de-Seine
city: Rennes
country: France
facility: Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 2901)
state: Ille-et-Vilaine
city: Montpellier
country: France
facility: Centre de Cancérologie du Grand Montpellier ( Site 2908)
state: Languedoc-Roussillon
city: Nantes
country: France
facility: Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 2905)
state: Loire-Atlantique
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1205)
state: Bayern
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn-Gynaecological oncology ( Site 1203)
state: Nordrhein-Westfalen
city: Düsseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204)
state: Nordrhein-Westfalen
city: Krefeld
country: Germany
facility: Zentrum fuer ambulante gynaekologische Onkologie (ZAGO) ( Site 1207)
state: Nordrhein-Westfalen
city: Saarbrücken
country: Germany
facility: CaritasKlinikum Saarbrücken St. Theresia ( Site 1211)
state: Saarland
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur
state: Sachsen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig-Department of Gynecology and Obstetrics ( Site 1213)
state: Sachsen
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum ( Site 1201)
city: Hamburg
country: Germany
facility: Asklepios Kliniken Hamburg-Asklepios Klinik Barmbek ( Site 1214)
city: Dublin
country: Ireland
facility: St. James's Hospital-Cancer clinical trials office ( Site 2821)
city: Afula
country: Israel
facility: Emek Medical Center-Gyn-Onc ( Site 1406)
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center ( Site 1404)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Gyneco-oncology unit ( Site 1402)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center ( Site 1405)
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center ( Site 1401)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 1407)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 1403)
city: Bologna
country: Italy
facility: IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1501)
state: Emilia-Romagna
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1503)
state: Lombardia
city: Monza
country: Italy
facility: Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1508)
state: Lombardia
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 1505)
state: Milano
city: Torino
country: Italy
facility: Ospedale Mauriziano-Ginecologia e Ostetricia ( Site 1507)
state: Piemonte
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia ( Site 1504)
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1502)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 1610)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 1609)
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 1603)
state: Ehime
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 1606)
state: Ehime
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 1607)
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido University Hospital ( Site 1604)
state: Hokkaido
city: Shiwa-gun Yahaba-cho
country: Japan
facility: Iwate Medical University Hospital ( Site 1613)
state: Iwate
city: Kawasaki
country: Japan
facility: Nippon Medical School Musashi Kosugi Hospital ( Site 1614)
state: Kanagawa
city: Hidaka-shi
country: Japan
facility: Saitama Medical University International Medical Center ( Site 1601)
state: Saitama
city: Nagaizumi
country: Japan
facility: Shizuoka Cancer Center ( Site 1611)
state: Shizuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital ( Site 1612)
state: Tokyo
city: Koto
country: Japan
facility: Japanese Foundation for Cancer Research ( Site 1605)
state: Tokyo
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 1602)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 2302)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 2303)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 2304)
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital ( Site 2301)
city: La Paz
country: Mexico
facility: Investigación Oncofarmacéutica-Investigación clínica ( Site 1706)
state: Baja California Sur
city: Mexico City
country: Mexico
facility: COI Centro Oncologico Internacional S.A.P.I. de C.V.-Investigation Unit COI ( Site 1703)
state: Distrito Federal
city: Mexico City
country: Mexico
facility: INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1701)
state: Distrito Federal
city: Monterrey
country: Mexico
facility: iCan Oncology Center Centro Medico AVE ( Site 1704)
state: Nuevo Leon
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca ( Site 1705)
city: Nijmegen
country: Netherlands
facility: Radboudumc ( Site 1802)
state: Gelderland
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum-Medical Oncology ( Site 1801)
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum-Medical Oncology ( Site 1803)
state: Zuid-Holland
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1804)
city: Auckland
country: New Zealand
facility: Auckland City Hospital ( Site 1901)
city: Tromsø
country: Norway
facility: Universitetssykehuset Nord-Norge HF-Kreftavdelingen ( Site 2001)
state: Troms
city: Warsaw
country: Poland
facility: Szpital Kliniczny im. Księżnej Anny Mazowieckiej ( Site 2103)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Gynecological Oncology Department ( Sit
state: Mazowieckie
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2106)
state: Podlaskie
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku-Uniwersyteckie Centrum Onkologii ( Site 2104)
state: Podlaskie
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi
state: Pomorskie
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 21
state: Slaskie
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2107)
state: Swietokrzyskie
city: Poznan
country: Poland
facility: Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Me-Oddzial Ginekologii Onkologicznej ( Sit
state: Wielkopolskie
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncology Dispensary-Chelyabinsk Regional Clinical Oncology Dispensary
state: Chelyabinskaya Oblast
city: Saransk
country: Russian Federation
facility: Ogarev Mordovia State University ( Site 2209)
state: Mordoviya, Respublika
city: Krasnogorsk D-t
country: Russian Federation
facility: Moscow City Oncology Hospital #62 ( Site 2214)
state: Moskovskaya Oblast
city: Moscow
country: Russian Federation
facility: Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF-Chemotherapy #2 ( Site 2211)
state: Moskva
city: Ekaterinburg
country: Russian Federation
facility: SVERDLOVSK REGIONAL ONCOLOGY DISPENSARY-Oncogynecology Department ( Site 2216)
state: Sverdlovskaya Oblast
city: Sarçam
country: Turkey
facility: cukurova universty ( Site 2706)
state: Adana
city: Fatih
country: Turkey
facility: Istanbul Universitesi Cerrahpasa ( Site 2709)
state: Istanbul
city: Bornova
country: Turkey
facility: Ege University Medicine of Faculty ( Site 2702)
state: Izmir
city: Adana
country: Turkey
facility: Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2704)
city: Ankara
country: Turkey
facility: Ankara University Hospital Cebeci ( Site 2701)
city: Ankara
country: Turkey
facility: Baskent Universitesi Ankara Hastanesi ( Site 2707)
city: Istanbul
country: Turkey
facility: Bezmialem Vakf Üniversitesi-Oncology ( Site 2705)
city: Istanbul
country: Turkey
facility: T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma
city: East Sussex
country: United Kingdom
facility: Brighton and Sussex University Hospitals NHS Trust ( Site 2803)
state: Brighton And Hove
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital ( Site 2808)
state: Cambridgeshire
city: Truro
country: United Kingdom
facility: The Royal Cornwall Hospital ( Site 2804)
state: Cornwall
city: Kendal
country: United Kingdom
facility: Westmorland General Hospital ( Site 2815)
state: Cumbria
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School ( Site 2826)
state: Dundee City
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 2812)
state: England
city: London
country: United Kingdom
facility: Hammersmith Hospital-Medical Oncology ( Site 2818)
state: London, City Of
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre ( Site 2805)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: