Clinical trial NCT05173987: Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)
Official title: A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab Versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTE-C93/GOG-3064/ENGOT-en15)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Endometrial Neoplasms
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: European Network of Gynaecological Oncological Trial Groups (ENGOT)
name: GOG Foundation
First posted: 2021-12-30
Enrollment: 280
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 purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy.

The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS).


Eligibility criteria: The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has a histologically confirmed diagnosis of inoperable, Stage III or IV or recurrent Endometrial Carcinoma (EC) or carcinosarcoma (mixed Mullerian tumor) that is centrally confirmed as dMMR.
* Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1, as assessed by the investigator. Note: primary Stage IVB that has undergone surgical resection is allowed regardless of presence of measurable or evaluable disease.
* Has received no prior systemic therapy for EC except for the following:

  1. May have received 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent resection if the recurrence occurred ≥6 months after the last dose of chemotherapy.
  2. May have received prior radiation with or without radiosensitizing chemotherapy if \>2 weeks before the start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
  3. May have received prior hormonal therapy for treatment of EC, provided that it was discontinued ≥1 week prior to randomization.
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
* Is not pregnant or breastfeeding and agrees to not donate eggs and use a highly effective contraceptive method for 120 days after the last dose of pembrolizumab or 180 days after the last dose of chemotherapy if a woman of childbearing potential (WOCBP).
* Has a negative highly sensitive pregnancy test (urine or serum) within 24 hours for urine or 72 hours for serum before the first dose of study intervention if a WOCBP.
* Provides an archival tumor tissue sample or newly obtained (core, incisional, or excisional) biopsy of a tumor lesion not previously irradiated for verification of dMMR status and histology.
* If Hepatitis B surface antigen (HBsAg) positive, has received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load prior to randomization.
* If has a history of Hepatitis C virus (HCV) infection, has undetectable HCV viral load at screening.

Exclusion Criteria:

* Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas and neuroendocrine tumors are not allowed.
* Has EC of any histology that is proficient mismatch repair (pMMR).
* Is a candidate for curative-intent surgery or curative-intent radiotherapy.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], Tumor necrosis factor receptor superfamily, member 4 \[OX 40\], tumor necrosis factor receptor superfamily member 9 \[CD137\]).
* Has received prior systemic anticancer therapy including investigational agents for any advanced or metastatic EC. (Note: Prior chemotherapy administered as adjuvant therapy, neoadjuvant therapy, and/or concurrently with radiation is permitted.
* Has had a major operation and has not recovered adequately from the procedure and/or any complications from the operation before starting study intervention.
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
* Is currently participating in or has participated in a study of an investigational agent for EC, has participated in a study of an investigational agent for non-EC within 4 weeks before the first dose of study intervention, or has used an investigational device within 4 weeks before the first dose of study intervention.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy are not excluded.
* Has known active CNS metastases and/or carcinomatous meningitis.
* Has a known intolerance to any study intervention and/or any of its excipients.
* Has an active autoimmune disease that has required systemic treatment in 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 had an allogenic tissue/solid organ transplant.

Primary outcomes:
measure: Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 45 months
measure: Overall Survival
timeFrame: Up to approximately 59 months
Secondary outcomes:
measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 45 months
measure: Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 45 months
measure: Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 45 months
measure: Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
timeFrame: Up to approximately 45 months
measure: Progression-Free Survival 2 (PFS2) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
timeFrame: Up to approximately 45 months
measure: Number of Participants Who Experience at Least One Adverse Event (AE)
timeFrame: Up to approximately 27 months
measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to approximately 24 months
measure: Change From Baseline in European Organization for Research And Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) (Item 29) And Quality of Life (QoL) (Item 30) Combined Score
timeFrame: Baseline and up to approximately 25 months
measure: Change From Baseline in European Organization for Research And Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Combined Score
timeFrame: Baseline and up to approximately 25 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: HonorHealth-USOR HonorHealth ( Site 8000)
state: Arizona
city: La Jolla
country: United States
facility: Moores Cancer Center ( Site 0037)
state: California
city: Riverside
country: United States
facility: Kaiser Permanente Riverside Medical Center ( Site 0045)
state: California
city: New Haven
country: United States
facility: Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0013)
state: Connecticut
city: Miami Beach
country: United States
facility: Mount Sinai Cancer Center ( Site 0018)
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital ( Site 0005)
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital ( Site 0017)
state: Georgia
city: Newnan
country: United States
facility: Southeastern Regional Medical Center ( Site 0046)
state: Georgia
city: Zion
country: United States
facility: Midwestern Regional Medical Center,Inc. DBA CTCA, Chicago ( Site 0003)
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Hospital and Health Care Center, Inc ( Site 0006)
state: Indiana
city: Lexington
country: United States
facility: Baptist Health Lexington ( Site 0042)
state: Kentucky
city: Rockville
country: United States
facility: Maryland Oncology Hematology, P.A.-USOR Maryland Oncology Hematology, P.A. ( Site 8002)
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts Medical School-Division of Gynecologic Oncology ( Site 0008)
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute ( Site 0029)
state: Michigan
city: Jackson
country: United States
facility: St. Dominic's Hospital ( Site 0024)
state: Mississippi
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0026)
state: New Jersey
city: New York
country: United States
facility: The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0023)
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0016)
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai ( Site 0052)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center ( Site 0009)
state: New York
city: Pinehurst
country: United States
facility: FirstHealth Clinical Trials ( Site 0050)
state: North Carolina
city: Bismarck
country: United States
facility: Sanford Medical Center ( Site 0054)
state: North Dakota
city: Fargo
country: United States
facility: Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0055)
state: North Dakota
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0039)
state: Ohio
city: Columbus
country: United States
facility: The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center ( Site 0031)
state: Oregon
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center - Jefferson Health ( Site 0053)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0034)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: AHN West Penn Hospital ( Site 0011)
state: Pennsylvania
city: Willow Grove
country: United States
facility: Asplundh Cancer Pavilion ( Site 0014)
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Cancer Center-Gynecologic Oncology ( Site 0002)
state: South Dakota
city: Austin
country: United States
facility: Texas Oncology - Austin-USOR Texas Oncology - Austin ( Site 8003)
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Dallas-USOR Texas Oncology - Dallas (Sammons) ( Site 8005)
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler-USOR Texas Oncology - Northeast Texas ( Site 8004)
state: Texas
city: Richmond
country: United States
facility: VCU Health Adult Outpatient Pavillion ( Site 0022)
state: Virginia
city: St Leonards
country: Australia
facility: Northern Cancer Institute ( Site 0206)
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital-Department of Gynaecological Oncology ( Site 0201)
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
state: Queensland
city: Clayton
country: Australia
facility: Monash Health ( Site 0202)
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0207)
state: Victoria
city: Melbourne
country: Australia
facility: Epworth Freemasons ( Site 0203)
state: Victoria
city: Subiaco
country: Australia
facility: St. John of God Subiaco Hospital-Oncology Clinical Trials Unit ( Site 0204)
state: Western Australia
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet-Medicine Oncology ( Site 0321)
state: Bruxelles-Capitale, Region De
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi-Oncology & Hematology ( Site 0323)
state: Hainaut
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0320)
state: Liege
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 3005)
state: Rio Grande Do Norte
city: São Paulo
country: Brazil
facility: ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 3001)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: A. C. Camargo Cancer Center-CAPEC ( Site 3003)
city: Edmonton
country: Canada
facility: Cross Cancer Institute ( Site 0513)
state: Alberta
city: Kelowna
country: Canada
facility: BC Cancer Kelowna ( Site 0517)
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer Vancouver-Clinical Trials Unit ( Site 0518)
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0509)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0510)
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital ( Site 0504)
state: Quebec
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal ( Site 0519)
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 0505)
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Center-Clinical Research Department ( Site 0520)
state: Saskatchewan
city: Santiago
country: Chile
facility: FALP-UIDO ( Site 0602)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0604)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill-Clinical Area ( Site 0603)
state: Region M. De Santiago
city: Hefei
country: China
facility: Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 0730)
state: Anhui
city: Beijing
country: China
facility: Beijing Obstetric and Gynecology Hospital ( Site 0740)
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital ( Site 0723)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer hospital ( Site 0715)
state: Beijing
city: Chongqing
country: China
facility: Southwest Hospital of Third Military Medical University ( Site 0719)
state: Chongqing
city: Chongqing
country: China
facility: 2nd Affiliated Hospital Chongqing Medical Universi ( Site 0745)
state: Chongqing
city: Fulingqu
country: China
facility: Fuling Central Hospital ( Site 0733)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital ( Site 0720)
state: Fujian
city: Guangzhou
country: China
facility: SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 0710)
state: Guangdong
city: Shantou
country: China
facility: Cancer Hospital of Shantou University Medical College ( Site 0732)
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated Hospital of Guangdong Medical College ( Site 0731)
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital-Gynecological oncology ( Site 0704)
state: Guangxi
city: Haikou
country: China
facility: Hainan General Hospital ( Site 0703)
state: Hainan
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital ( Site 0711)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 0713)
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital-Medical Oncology ( Site 0716)
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University-Gynecology ( Site 0708)
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 0709)
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital-Oncology Department ( Site 0707)
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University ( Site 0729)
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University ( Site 0705)
state: Jilin
city: XI An
country: China
facility: Shaanxi Provincial Cancer Hospital ( Site 0714)
state: Shaanxi
city: Binzhou
country: China
facility: Binzhou Medical University Hospital-Oncology department ( Site 0735)
state: Shandong
city: Shanghai
country: China
facility: Obstetrics & Gynecology Hospital of Fudan University ( Site 0702)
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 0717)
state: Shanghai
city: Chengdu
country: China
facility: West China Second University Hospital Sichuan University ( Site 0701)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital ( Site 0706)
state: Tianjin
city: Kunming
country: China
facility: Yunnan Province Cancer Hospital-Gynecology Department ( Site 0721)
state: Yunnan
city: Hangzhou
country: China
facility: The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0726)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital-Oncology ( Site 0700)
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0725)
state: Zhejiang
city: Brno
country: Czechia
facility: Fakultní nemocnice Brno Bohunice-Gynekologicko-porodnicka klinika ( Site 0404)
state: Brno-mesto
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 0403)
state: Moravskoslezsky Kraj
city: Nový Jiín
country: Czechia
facility: Nemocnice AGEL Novy Jicin a.s.-Oddeleni radioterapie a onkologie ( Site 0406)
state: Novy Jicin
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0402)
state: Olomoucky Kraj
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 0405)
state: Praha 2
city: Praha
country: Czechia
facility: Fakultni nemocnice Bulovka-Gynekologicko-porodnicka klinika ( Site 0401)
state: Praha 8
city: Zlín
country: Czechia
facility: Nemocnice Tomase Bati ve Zline-Onkologické oddělení ( Site 0407)
state: Zlinsky Kraj
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady-Gynekologicko-porodnická klinika ( Site 0408)
city: Copenhagen
country: Denmark
facility: Rigshospitalet ( Site 0903)
state: Hovedstaden
city: Copenhagen
country: Denmark
facility: Herlev and Gentofte Hospital ( Site 0902)
state: Hovedstaden
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital, Syd ( Site 0905)
state: Nordjylland
city: Roskilde
country: Denmark
facility: Roskilde Sygehus-Oncology department ( Site 0904)
state: Sjaelland
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala-Gynecology and Obstetrics ( Site 1001)
state: Pirkanmaa
city: Kuopio
country: Finland
facility: Kuopion Yliopistollinen Sairaala ( Site 1002)
state: Pohjois-Savo
city: Helsinki
country: Finland
facility: Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1003)
state: Uusimaa
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm ( Site 1106)
state: Baden-Wurttemberg
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn-Gynaecological oncology ( Site 1105)
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur
state: Sachsen
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum ( Site 1103)
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet-Ngyógyászat ( Site 1201)
city: Cork
country: Ireland
facility: Bon Secours Cork Hospital ( Site 1305)
city: Dublin
country: Ireland
facility: St. James's Hospital-Cancer clinical trials office ( Site 1301)
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center ( Site 1403)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Gyneco-oncology unit ( Site 1402)
city: Holon
country: Israel
facility: Edith Wolfson Medical Center-Obstetrics & Gynecology ( Site 1405)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center ( Site 1404)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 1401)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 1
state: Campania
city: Bologna
country: Italy
facility: IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1503)
state: Emilia-Romagna
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1513)
state: Emilia-Romagna
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli-Ginecologia Oncologica ( Site 1502)
state: Lazio
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 150
state: Lombardia
city: Torino
country: Italy
facility: Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 1514)
state: Piemonte
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena-Oncologia Medica 1 ( Site 1504)
state: Roma
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1509)
state: Toscana
city: Vicenza
country: Italy
facility: AULSS8 Berica-Ospedale S.Bortolo-ONCOLOGIA CLINICA ( Site 1510)
state: Veneto
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1506)
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 1604)
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 1611)
state: Ehime
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 1614)
state: Ehime
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 1612)
state: Fukuoka
city: Ota
country: Japan
facility: Gunma Prefectural Cancer Center-Gynecology ( Site 1603)
state: Gunma
city: Sapporo
country: Japan
facility: Hokkaido University Hospital ( Site 1601)
state: Hokkaido
city: Tsukuba
country: Japan
facility: Tsukuba University Hospital ( Site 1618)
state: Ibaraki
city: Shiwa-gun Yahaba-cho
country: Japan
facility: Iwate Medical University Hospital ( Site 1602)
state: Iwate
city: Chuo-ku, Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital ( Site 1613)
state: Niigata
city: Hidaka-shi
country: Japan
facility: Saitama Medical University International Medical Center ( Site 1605)
state: Saitama
city: Nagaizumi-cho,Sunto-gun
country: Japan
facility: Shizuoka Cancer Center ( Site 1609)
state: Shizuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital ( Site 1607)
state: Tokyo
city: Koto
country: Japan
facility: Japanese Foundation for Cancer Research ( Site 1616)
state: Tokyo
city: Minato-ku
country: Japan
facility: The Jikei University Hospital ( Site 1615)
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: Keio university hospital ( Site 1606)
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 1608)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 1617)
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 2301)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 2303)
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital ( Site 2304)
city: Nijmegen
country: Netherlands
facility: Radboudumc-Medical Oncology ( Site 1703)
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht UMC+ ( Site 1709)
state: Limburg
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis-Oncology ( Site 1704)
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC ( Site 1706)
state: Noord-Holland
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum-Medical Oncology ( Site 1702)
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum-Medical Oncology ( Site 1701)
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: University Medical Center Groningen ( Site 1707)
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1705)
city: Auckland
country: New Zealand
facility: Auckland City Hospital-Cancer & Blood Research ( Site 1801)
city: Oslo
country: Norway
facility: Oslo universitetssykehus, Radiumhospitalet ( Site 1901)
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej ( Site 2006)
state: Lubelskie
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2007)
state: Mazowieckie
city: Warsaw
country: Poland
facility: Szpital Kliniczny im. Księżnej Anny Mazowieckiej ( Site 2009)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Sit
state: Mazowieckie
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2003)
state: Podlaskie
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 20
state: Slaskie
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2010)
state: Swietokrzyskie
city: Poznan
country: Poland
facility: Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Me-Oddzial Ginekologii Onkologicznej ( Sit
state: Wielkopolskie
city: Krasnogorsk
country: Russian Federation
facility: Moscow City Oncology Hospital #62 ( Site 2204)
state: Moskovskaya Oblast
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Cancer Hospital-Oncology ( Site 2202)
state: Yaroslavskaya Oblast
city: Hospitalet
country: Spain
facility: Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2406)
state: Barcelona
city: A Coruña
country: Spain
facility: CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2405)
state: La Coruna
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2402)
state: Madrid, Comunidad De
city: Pamplona
country: Spain
facility: COMPLEJO HOSPITALARIO DE NAVARRA ( Site 2407)
state: Navarra
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2404)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron ( Site 2403)
city: Sevilla
country: Spain
facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2401)
city: Lund
country: Sweden
facility: Skånes Universitetssjukhus Lund-Department of Hematology ( Site 2504)
state: Skane Lan
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset Solna ( Site 2502)
state: Stockholms Lan
city: Umeå
country: Sweden
facility: Norrlands universitetssjukhus-Cancercentrum ( Site 2503)
state: Vasterbottens Lan
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 2602)
city: Tainan
country: Taiwan
facility: NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2604)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 2603)
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital ( Site 2601)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 2605)
city: Fatih
country: Turkey
facility: Istanbul Universitesi Cerrahpasa ( Site 2702)
state: Istanbul
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-oncology hospital ( Site 2704)
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2706)
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Hastanesi ( Site 2701)
city: Istanbul
country: Turkey
facility: Istanbul University Capa Campus-department of obstetrics and gynaecology ( Site 2705)
city: Istanbul
country: Turkey
facility: T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma
city: London
country: United Kingdom
facility: St Bartholomew's Hospital ( Site 2804)
state: England
city: Manchester
country: United Kingdom
facility: The Christie ( Site 2807)
state: England
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre ( Site 2805)
state: Glasgow City
city: London
country: United Kingdom
facility: ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2806)
state: London, City Of
city: London
country: United Kingdom
facility: Hammersmith Hospital-Medical Oncology ( Site 2808)
state: London, City Of
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: