Clinical trial NCT06459180: A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)
Official title: A Phase 3 Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (TroFuse-020/GOG-3101/ENGOT-cx20)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cervical Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: European Network of Gynaecological Oncological Trial Groups (ENGOT)
name: GOG Foundation
First posted: 2024-06-14
Enrollment: 686
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: This study will have two phases: a sacituzumab tirumotecan safety run-in and a Phase 3 portion. The safety run-in phase will be used to evaluate the efficacy and safety of sacituzumab tirumotecan at the dose for evaluation in the Phase 3 portion. The purpose of this study is to compare the efficacy and safety of sacituzumab tirumotecan versus treatment of physician's choice as second-line treatment for participants with recurrent or metastatic cervical cancer in the Phase 3 portion.

The primary study hypotheses are that, in the Phase 3 portion, sacituzumab tirumotecan results in a superior overall survival compared to TPC in participants with high trophoblast cell surface antigen 2 (TROP2) expression level and in all participants.


Eligibility criteria: Inclusion Criteria:

* Has histologically-confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
* Must have recurrent or metastatic cervical cancer that has progressed on or after treatment with 1 prior line of systemic platinum doublet chemotherapy (with or without bevacizumab) AND must have received anti-PD-1/anti-PD-L1 therapy as part of prior cervical cancer regimens
* Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed by the investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions
* Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent
* Has ECOG performance status of 0 or 1 within 7 days before allocation for the Sacituzumab Tirumotecan Run-in or within 7 days before randomization for the Phase 3 portion
* Has provided tumor tissue (most recent sample is preferred) from a core or excisional biopsy of a tumor lesion not previously irradiated
* HIV-infected participants must have well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Sacituzumab Tirumotecan Run-in) or randomization (Phase 3 portion)
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
* Has adequate organ function

Exclusion Criteria:

* Has Grade ≥2 peripheral neuropathy
* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
* Received prior systemic anticancer therapy
* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
* Has histological subtypes of cervical cancer other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (eg, carcinosarcoma) or nonepithelial cancer (eg, sarcoma, neuroendocrine tumors)
* Known additional malignancy that is progressing or has required active treatment within the past 3 years
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Active infection requiring systemic therapy
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Concurrent active Hepatitis B and active Hepatitis C virus infection
* Severe hypersensitivity (≥Grade 3) to sacituzumab tirumotecan or treatment of physician's choice (TPC) and/or any of their excipients, or other biologic therapy
* Participants who have not adequately recovered from major surgery or have ongoing surgical complications
* Has a history of (noninfectious) pneumonitis/ILD that required steroids or has current pneumonitis/ILD

Primary outcomes:
measure: Objective Response Rate (ORR) in Sacituzumab Tirumotecan Run-in
timeFrame: Up to approximately 51 months
measure: Number of Participants Experiencing One or More Adverse Events (AEs) in Sacituzumab Tirumotecan Run-in
timeFrame: Up to approximately 51 months
measure: Number of Participants Discontinuing Study Treatment Due to an AE in Sacituzumab Tirumotecan Run-in
timeFrame: Up to approximately 51 months
measure: Overall Survival (OS) in Phase 3 Portion
timeFrame: Up to approximately 43 months
Secondary outcomes:
measure: Progression-free Survival (PFS) in Phase 3 Portion
timeFrame: Up to approximately 43 months
measure: ORR in Phase 3 Portion
timeFrame: Up to approximately 43 months
measure: Duration of Response (DOR) in Phase 3 Portion
timeFrame: Up to approximately 43 months
measure: Number of Participants Experiencing One or More AEs in Phase 3 Portion
timeFrame: Up to approximately 51 months
measure: Number of Participants Discontinuing Study Treatment Due to an AE in Phase 3 Portion
timeFrame: Up to approximately 51 months
measure: Time to First Deterioration (TTD) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score in Phase 3 Portion
timeFrame: Baseline and up to approximately 51 months
measure: Change from Baseline in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score in Phase 3 Portion
timeFrame: Baseline and up to approximately 51 months
measure: Change from Baseline in EORTC QLQ-C30 Physical Functioning Score in Phase 3 Portion
timeFrame: Baseline and up to approximately 51 months
measure: Change from Baseline in EORTC QLQ-C30 Role Functioning Score in Phase 3 Portion
timeFrame: Baseline and up to approximately 51 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: USA Mitchell Cancer Institute-Clinical Trials ( Site 4126)
state: Alabama
city: Anchorage
country: United States
facility: Providence Alaska Medical Center ( Site 4137)
state: Alaska
city: Phoenix
country: United States
facility: HonorHealth (HH) ( Site 8002)
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates - HOPE ( Site 8001)
state: Arizona
city: La Jolla
country: United States
facility: Moores Cancer Center-Clinical Trials Office - Gynecological Oncology ( Site 4125)
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4105)
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian ( Site 4104)
state: California
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center ( Site 4143)
state: Florida
city: Orlando
country: United States
facility: Advent Health ( Site 4140)
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists East ( Site 7001)
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital ( Site 4127)
state: Georgia
city: Augusta
country: United States
facility: Georgia Cancer Center at Augusta University ( Site 4112)
state: Georgia
city: Savannah
country: United States
facility: Lewis Cancer and Research Pavilion ( Site 4114)
state: Georgia
city: New Orleans
country: United States
facility: University Medical Center New Orleans ( Site 4132)
state: Louisiana
city: Shreveport
country: United States
facility: Willis Knighton Medical Center ( Site 4101)
state: Louisiana
city: Reno
country: United States
facility: The Center of Hope ( Site 4106)
state: Nevada
city: Teaneck
country: United States
facility: Holy Name Medical Center ( Site 4117)
state: New Jersey
city: Albuquerque
country: United States
facility: Optimum Clinical Research Group ( Site 4138)
state: New Mexico
city: Durham
country: United States
facility: Duke Cancer Institute ( Site 4120)
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center ( Site 4128)
state: Ohio
city: Hilliard
country: United States
facility: The Ohio State University ( Site 4103)
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research ( Site 4116)
state: Oklahoma
city: Eugene
country: United States
facility: Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)
state: Oregon
city: Portland
country: United States
facility: Legacy Good Samaritan Medical Center-Oncology Clinical Research ( Site 4115)
state: Oregon
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center - Jefferson Health ( Site 4142)
state: Pennsylvania
city: Willow Grove
country: United States
facility: Asplundh Cancer Pavilion ( Site 4113)
state: Pennsylvania
city: Fort Worth
country: United States
facility: Texas Oncology - DFW ( Site 8003)
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital OB/GYN ( Site 4102)
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio ( Site 8006)
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center ( Site 4123)
state: Virginia
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute ( Site 4139)
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center-Swedish Cancer Institute ( Site 4134)
state: Washington
city: Ciudad autónoma de Buenos Aires
country: Argentina
facility: Hospital Británico de Buenos Aires-Oncology ( Site 0102)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0107)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Instituto de Oncología Angel H. Roffo ( Site 0103)
state: Caba
city: Córdoba
country: Argentina
facility: Sanatorio Allende - Cerro-Oncology ( Site 0106)
state: Cordoba
city: Buenos Aires
country: Argentina
facility: Hospital Aleman-Oncology ( Site 0100)
city: Caba
country: Argentina
facility: Instituto Alexander Fleming ( Site 0108)
city: Caba
country: Argentina
facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0109)
city: La Rioja
country: Argentina
facility: Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0104)
city: Sydney
country: Australia
facility: Blacktown Hospital ( Site 3006)
state: New South Wales
city: Sydney
country: Australia
facility: Campbelltown Hospital-Macarthur Cancer Therapy Centre Medical Oncology ( Site 3000)
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital ( Site 3001)
state: Queensland
city: Clayton
country: Australia
facility: Monash Health-Oncology Research ( Site 3002)
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 3005)
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital ( Site 3003)
state: Western Australia
city: Linz
country: Austria
facility: Kepler Universitätsklinikum-Department for Oncology and Hematology ( Site 1002)
state: Oberosterreich
city: Graz
country: Austria
facility: Medizinische Universität Graz-Abteilung für Gynäkologie / Onkologie ( Site 1003)
state: Steiermark
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 1000)
state: Tirol
city: Wien
country: Austria
facility: Medizinische Universität Wien ( Site 1001)
city: Aalst
country: Belgium
facility: AZORG Campus Aalst-Moorselbaan ( Site 2905)
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: UZ Gent-Medical oncology ( Site 2901)
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven-Gynecologic Oncology ( Site 2900)
state: Vlaams-Brabant
city: Belgium
country: Belgium
facility: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman-Medical Oncology ( Site 2904)
state: Wallonne, Region
city: Namur
country: Belgium
facility: CHU UCL Namur/Site Sainte Elisabeth-Trial Office ( Site 2902)
city: Curitiba
country: Brazil
facility: Instituto do Câncer e Transplante de Curitiba ( Site 0205)
state: Parana
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento-Centro de Pesquisa Clínica ( Site 0204)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital do Câncer Mãe de Deus ( Site 0201)
state: Rio Grande Do Sul
city: Joinville
country: Brazil
facility: Centro de Hematologia e Oncologia ( Site 0203)
state: Santa Catarina
city: São Paulo
country: Brazil
facility: IBCC - Instituto Brasileiro de Controle do Câncer-Centro de Pesquisa Clínica ( Site 0200)
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Americas Centro de Oncologia Integrado ( Site 0202)
city: Sao Paulo
country: Brazil
facility: Hospital Paulistano ( Site 0209)
city: Panagyurishte
country: Bulgaria
facility: MBAL Uni Hospital-Department of Medical Oncology ( Site 1104)
state: Pazardzhik
city: Pleven
country: Bulgaria
facility: MHAT - Heart and Brain ( Site 1100)
city: Plovdiv
country: Bulgaria
facility: Complex Oncology Center - Plovdiv EOOD ( Site 1102)
city: Kelowna
country: Canada
facility: BC Cancer Kelowna ( Site 4007)
state: British Columbia
city: Surrey
country: Canada
facility: BC Cancer Surrey ( Site 4006)
state: British Columbia
city: Victoria
country: Canada
facility: BC Cancer Victoria ( Site 4008)
state: British Columbia
city: Montreal
country: Canada
facility: McGill University Health Centre ( Site 4000)
state: Quebec
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal ( Site 4001)
state: Quebec
city: Quebec City
country: Canada
facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 4002)
state: Quebec
city: Santiago
country: Chile
facility: FALP-UIDO ( Site 0300)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0302)
state: Region M. De Santiago
city: Viña del Mar
country: Chile
facility: ONCOCENTRO APYS-ACEREY ( Site 0303)
state: Valparaiso
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital-Gynecological Oncology ( Site 5040)
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hospital ( Site 5011)
state: Anhui
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital ( Site 5045)
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital ( Site 5003)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospial ( Site 5012)
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated hospital of Xiamen University-Obstetrics and gynecology department ( Site 5027)
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 5001)
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center-Internal medicine ( Site 5006)
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated Hospital of Guangdong Medical University ( Site 5004)
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital ( Site 5016)
state: Guangxi
city: Haikou
country: China
facility: Hainan General Hospital ( Site 5032)
state: Hainan
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 5041)
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 5026)
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital ( Site 5020)
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 5019)
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 5021)
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University ( Site 5009)
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital-Oncology Department ( Site 5018)
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Maternal and Child Health Hospital ( Site 5031)
state: Jiangxi
city: Changchun
country: China
facility: Jilin Province Tumor Hospital ( Site 5036)
state: Jilin
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University ( Site 5007)
state: Shaanxi
city: Jinan
country: China
facility: Shandong Cancer Hospital ( Site 5014)
state: Shandong
city: Linyi
country: China
facility: LinYi Cancer Hospital-Gastrology department ( Site 5039)
state: Shandong
city: Shanghai
country: China
facility: Obstetrics & Gynecology Hospital of Fudan University ( Site 5015)
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital ( Site 5043)
state: Shanxi
city: Chengdu
country: China
facility: West China Second University Hospital, Sichuan University ( Site 5017)
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Cancer hospital-Oncology ( Site 5030)
state: Sichuan
city: Kunming
country: China
facility: Yunnan Province Cancer Hospital-Gynecology Department ( Site 5005)
state: Yunnan
city: Hangzhou
country: China
facility: Women s Hospital School of Medicine Zhejiang University ( Site 5022)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 5008)
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University ( Site 5033)
state: Zhejiang
city: Valledupar
country: Colombia
facility: Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0401)
state: Cesar
city: Montería
country: Colombia
facility: IMAT S.A.S ( Site 0402)
state: Cordoba
city: Bogota.
country: Colombia
facility: FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0403)
state: Distrito Capital De Bogota
city: Pereira.
country: Colombia
facility: Oncologos del Occidente ( Site 0405)
state: Risaralda
city: Cali
country: Colombia
facility: Fundación Valle del Lili ( Site 0406)
state: Valle Del Cauca
city: Kobenhavn
country: Denmark
facility: Rigshospitalet-Dept. of Oncology ( Site 1300)
state: Hovedstaden
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Skejby ( Site 1301)
state: Midtjylland
city: Odense C
country: Denmark
facility: Odense Universitetshospital-Department of oncology ( Site 1302)
state: Syddanmark
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala-Gynecology and Obstetrics ( Site 1404)
state: Pirkanmaa
city: Helsinki
country: Finland
facility: Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1400)
state: Uusimaa
city: Turku
country: Finland
facility: Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1401)
state: Varsinais-Suomi
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1501)
state: Alsace
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1503)
state: Aquitaine
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1508)
state: Auvergne
city: Marseille
country: France
facility: Institut Paoli-Calmettes ( Site 1504)
state: Bouches-du-Rhone
city: Plérin
country: France
facility: Hôpital Privé Des Côtes d'Armor ( Site 1510)
state: Cotes-d Armor
city: Besancon
country: France
facility: CHU Besançon ( Site 1507)
state: Franche-Comte
city: Toulouse
country: France
facility: Oncopole Claudius Regaud ( Site 1502)
state: Haute-Garonne
city: Montpellier
country: France
facility: Institut Regional du Cancer Montpellier ( Site 1511)
state: Herault
city: Villejuif
country: France
facility: Gustave Roussy ( Site 1512)
state: Ile-de-France
city: Nantes
country: France
facility: Hôpital privé du Confluent SAS ( Site 1509)
state: Loire-Atlantique
city: Lyon Cedex08
country: France
facility: CENTRE LEON BERARD ( Site 1505)
state: Rhone-Alpes
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 1506)
city: Athens
country: Greece
facility: Aretaieio Hospital ( Site 1700)
state: Attiki
city: Athens
country: Greece
facility: Mitera Hospital ( Site 1702)
state: Attiki
city: Chaidari
country: Greece
facility: ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1703)
state: Attiki
city: Patras
country: Greece
facility: Agios Andreas Hospital Patras ( Site 1701)
state: Peloponnisos
city: Cork
country: Ireland
facility: Cork University Hospital ( Site 1900)
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital ( Site 1901)
city: Dublin
country: Ireland
facility: St. James's Hospital-Cancer clinical trials office ( Site 1902)
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 2002)
city: Holon
country: Israel
facility: Edith Wolfson Medical Center ( Site 2003)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center ( Site 2000)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 2001)
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlin-DEPARTMENT OF EXPERIMENTAL, DIAGNOSTIC ( Site 2105)
state: Emilia-Romagna
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS ( Site 2108)
state: Lombardia
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 2107)
state: Lombardia
city: Milan
country: Italy
facility: Ospedale Humanitas San Pio X ( Site 2113)
state: Lombardia
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori-Oncologia ( Site 2111)
state: Lombardia
city: Rozzano
country: Italy
facility: Humanitas University ( Site 2112)
state: Milano
city: Torino
country: Italy
facility: Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 2100)
state: Piemonte
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia-Obstetrics anf gynecology ( Site 2110)
city: Catania
country: Italy
facility: Ospedale Cannizzaro ( Site 2104)
city: Milano
country: Italy
facility: Ospedale San Raffaele. ( Site 2106)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2103)
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS ( Site 2109)
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2102)
city: Nagoya
country: Japan
facility: Aichi Cancer Center ( Site 5110)
state: Aichi
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 5109)
state: Ehime
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 5102)
state: Ehime
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 5105)
state: Fukuoka
city: Ohta
country: Japan
facility: Gunma Prefectural Cancer Center ( Site 5116)
state: Gunma
city: Sapporo
country: Japan
facility: Hokkaido University Hospital ( Site 5106)
state: Hokkaido
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital ( Site 5114)
state: Ibaraki
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital ( Site 5112)
state: Iwate
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center ( Site 5117)
state: Saitama
city: Sunto-gun,
country: Japan
facility: Shizuoka Cancer Center ( Site 5107)
state: Shizuoka
city: Chuo
country: Japan
facility: National Cancer Center Hospital ( Site 5108)
state: Tokyo
city: Koto
country: Japan
facility: Cancer Institute Hospital of JFCR ( Site 5111)
state: Tokyo
city: Shinjyuku
country: Japan
facility: Keio University Hospital ( Site 5101)
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 5104)
city: Kagoshima
country: Japan
facility: Kagoshima City Hospital ( Site 5115)
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital ( Site 5100)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 5103)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 3403)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System ( Site 3402)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 3401)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 3400)
city: Lembah Pantai
country: Malaysia
facility: University Malaya Medical Centre ( Site 3102)
state: Kuala Lumpur
city: Petaling Jaya
country: Malaysia
facility: Sunway Medical Centre ( Site 3105)
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Pantai Hospital Kuala Lumpur ( Site 3100)
city: Pulau Pinang
country: Malaysia
facility: Penang Adventist Hospital ( Site 3101)
city: Nijmegen
country: Netherlands
facility: Radboudumc-Medical Oncology ( Site 2202)
state: Gelderland
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis-Oncology ( Site 2203)
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie VUmc ( Site 2201)
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum-Medical Oncology ( Site 2200)
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: University Medical Center Groningen ( Site 2204)
city: Oslo
country: Norway
facility: Oslo universitetssykehus, Radiumhospitalet ( Site 2300)
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Site 2400)
state: Mazowieckie
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2402)
state: Podlaskie
city: Poznan
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 2404)
state: Wielkopolskie
city: San Juan
country: Puerto Rico
facility: UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 0601)
city: Singapore
country: Singapore
facility: National University Hospital ( Site 3301)
state: Central Singapore
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore ( Site 3300)
state: Central Singapore
city: Barcelona
country: Spain
facility: HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2509)
state: Cataluna
city: L Hospitalet De Llobregat
country: Spain
facility: Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2508)
state: Cataluna
city: Girona
country: Spain
facility: Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 2507)
state: Gerona
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra ( Site 2510)
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2502)
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2506)
state: Madrid, Comunidad De
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2503)
state: Valenciana, Comunitat
city: Valencia
country: Spain
facility: HOSPITAL CLINICO DE VALENCIA ( Site 2505)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2500)
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia-Oncologia Medica ( Site 2501)
city: Madrid
country: Spain
facility: Hospital Universitario La Paz-Oncología Médica ( Site 2504)
city: Linköping
country: Sweden
facility: Universitetssjukhuset i Linköping ( Site 2600)
state: Ostergotlands Lan
city: Lund
country: Sweden
facility: Skånes Universitetssjukhus Lund-Department of Hematology ( Site 2602)
state: Skane Lan
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna ( Site 2601)
state: Stockholms Lan
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset ( Site 2603)
state: Uppsala Lan
city: Basel
country: Switzerland
facility: University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 2701)
state: Basel-Stadt
city: Berne
country: Switzerland
facility: Inselspital Bern-Oncology ( Site 2700)
city: London
country: United Kingdom
facility: ROYAL MARSDEN HOSPITAL (CHELSEA)-Gynaecology Research Centre ( Site 2807)
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 2801)
state: England
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital-Clinical Trials Unit ( Site 2800)
state: Glasgow City
city: London
country: United Kingdom
facility: University College London Hospital ( Site 2805)
state: London, City Of
city: Leeds
country: United Kingdom
facility: St James's University Hospital ( Site 2804)
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust-Research and Development ( Site 2802)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: