Clinical trial NCT06132958: Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)
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 in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy (MK-2870-005/ENGOT-en23/GOG-3095)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Endometrial Cancer
Keywords: Endometrial cancer
Antibody-drug conjugate (ADC)
Trophoblast cell-surface antigen 2 (TROP2)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: European Network for Gynaecological Oncological Trial groups(ENGOT)
name: GOG Foundation
First posted: 2023-11-15
Enrollment: 710
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: Researchers are looking for new ways to treat people with endometrial cancer (EC) who have previously received treatment with platinum based therapy (a type of chemotherapy) and immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. This clinical study will compare sacituzumab tirumotecan to chemotherapy. The goal of the study is to learn if people who receive sacituzumab tirumotecan live longer overall and without the cancer getting worse compared to people who receive chemotherapy.


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

Inclusion Criteria:

* Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
* Has radiographically evaluable disease, either measurable or nonmeasurable per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR).
* Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.

Exclusion Criteria:

* Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas
* Has a 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
* Has had a recurrence of endometrial carcinoma or carcinosarcoma more than \>12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting. Note: 1) If Immunotherapy-based treatment is administered in the recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from time of adjuvant therapy 2) For Stage IVb disease, treatment that includes gynecological surgery followed by a platinum-based regimen is NOT considered curative-intent per protocol and does not require platinum rechallenge in the recurrent setting, regardless of the duration of the platinum-free interval
* Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma
* Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has received prior treatment with single-agent nonplatinum based chemotherapy in the third-line setting
* Has received prior treatment with a trophoblast cell surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC) (eg, sacituzumab govitecan)
* Has received prior treatment with a topoisomerase I inhibitor-containing ADC (eg, sacituzumab govitecan or fam-trastuzumab deruxtecan-nxki)
* Has previously received both single-agent paclitaxel and single-agent doxorubicin in any setting for prior treatment of endometrial cancer
* Requires recurrent drainage of effusions (e.g., pleural, ascitic, etc.) within 6 weeks before randomization

Primary outcomes:
measure: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 4 years
measure: Overall Survival (OS)
timeFrame: Up to approximately 4 years
Secondary outcomes:
measure: Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR
timeFrame: Up to approximately 4 years
measure: Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
timeFrame: Up to approximately 4 years
measure: Number of Participants Who Experience One or More Adverse Events (AEs)
timeFrame: Up to approximately 4 years
measure: Number of Participants Who Discontinue Study Intervention Due to an AE
timeFrame: Up to approximately 4 years
measure: Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30])
timeFrame: Baseline, up to approximately 4 years
Other outcomes:
Locations:
city: Mobile
country: United States
facility: USA Mitchell Cancer Institute ( Site 4142)
state: Alabama
city: Anchorage
country: United States
facility: Alaska Womens Cancer Care ( Site 4122)
state: Alaska
city: Phoenix
country: United States
facility: HonorHealth (HH) ( Site 8000)
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates - HOPE ( Site 8002)
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4131)
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center - Van Ness Campus ( Site 4129)
state: California
city: New Haven
country: United States
facility: Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 4114)
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center ( Site 4108)
state: District of Columbia
city: Miami Beach
country: United States
facility: Mount Sinai Cancer Center ( Site 4117)
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 4113)
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists - East ( Site 7000)
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital ( Site 4112)
state: Georgia
city: Augusta
country: United States
facility: Augusta University ( Site 4116)
state: Georgia
city: Columbus
country: United States
facility: Centricity Research Columbus Cancer Center ( Site 4154)
state: Georgia
city: Evanston
country: United States
facility: NorthShore University HealthSystem - Evanston Hospital ( Site 4110)
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center at Parkview Regional Medical Center ( Site 4132)
state: Indiana
city: Edgewood
country: United States
facility: Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 4150)
state: Kentucky
city: New Orleans
country: United States
facility: University Medical Center New Orleans ( Site 4133)
state: Louisiana
city: Shreveport
country: United States
facility: TRIALS 365 ( Site 4105)
state: Louisiana
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center ( Site 4103)
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine-Obstetrics & Gynecology ( Site 4146)
state: Missouri
city: Reno
country: United States
facility: The Center of Hope ( Site 4109)
state: Nevada
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 4118)
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Health System Morristown Medical Center ( Site 4135)
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center ( Site 4115)
state: New Jersey
city: Brooklyn
country: United States
facility: New York - Presbyterian Brooklyn Methodist Hospital ( Site 4134)
state: New York
city: Mineola
country: United States
facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 4156)
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center ( Site 4106)
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai-Department of Obstetrics, Gynecology, and Reproductive Scie ( Site 4128)
state: New York
city: West Islip
country: United States
facility: Good Samaritan Hospital Medical Center ( Site 4139)
state: New York
city: Durham
country: United States
facility: Duke Cancer Institute ( Site 4120)
state: North Carolina
city: Fargo
country: United States
facility: Sanford Health Roger Maris Cancer Center ( Site 4158)
state: North Dakota
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center ( Site 4136)
state: Ohio
city: Columbus
country: United States
facility: The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 4125)
state: Ohio
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center - Jefferson Health ( Site 4157)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: AHN West Penn Hospital-Gynecologic Oncology ( Site 4111)
state: Pennsylvania
city: Willow Grove
country: United States
facility: Asplundh Cancer Pavilion ( Site 4107)
state: Pennsylvania
city: Providence
country: United States
facility: Women & Infants Hospital ( Site 4138)
state: Rhode Island
city: Sioux Falls
country: United States
facility: Sanford Cancer Center-Gynecologic Oncology ( Site 4121)
state: South Dakota
city: Germantown
country: United States
facility: The West Clinic, PLLC dba West Cancer Center ( Site 4102)
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Hospital-Obstetrics and Gynecology ( Site 4130)
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio ( Site 8005)
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - Gulf Coast ( Site 8006)
state: Texas
city: Ciudad autónoma de Buenos Aires
country: Argentina
facility: Hospital Británico de Buenos Aires-Oncology ( Site 1002)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1008)
state: Caba
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming-Alexander Fleming ( Site 1007)
state: Caba
city: Buenos Aires
country: Argentina
facility: Hospital Aleman-Oncology ( Site 1001)
city: Buenos Aires
country: Argentina
facility: Instituto de Oncología Angel H. Roffo ( Site 1003)
city: Buenos Aires
country: Argentina
facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 1004)
city: La Rioja
country: Argentina
facility: Fundación CORI para la Investigación y Prevención del Cáncer ( Site 1006)
city: St Leonards
country: Australia
facility: GenesisCare North Shore ( Site 1103)
state: New South Wales
city: Sydney
country: Australia
facility: Blacktown Hospital ( Site 1101)
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital ( Site 1102)
state: Queensland
city: East Melbourne
country: Australia
facility: Epworth Freemasons ( Site 1104)
state: Victoria
city: Frankston
country: Australia
facility: Frankston Hospital ( Site 1105)
state: Victoria
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 1201)
state: Tirol
city: Wien
country: Austria
facility: Medizinische Universität Wien ( Site 1202)
city: Gent
country: Belgium
facility: AZ Maria Middelares-IKG ( Site 1305)
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: UZ Gent-Medical oncology ( Site 1303)
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven-Gynecologic Oncology ( Site 1301)
state: Vlaams-Brabant
city: Roeselare
country: Belgium
facility: AZ Delta vzw-Oncology ( Site 1302)
state: West-Vlaanderen
city: Namur
country: Belgium
facility: CHU UCL Namur/Site Sainte Elisabeth-Trial Office ( Site 1304)
city: Sao Luis
country: Brazil
facility: Hospital São Domingos ( Site 1365)
state: Maranhao
city: Uberlândia
country: Brazil
facility: Centro Oncologico do Triangulo ( Site 1360)
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento ( Site 1359)
state: Rio Grande Do Sul
city: Joinville
country: Brazil
facility: Instituto Joinvilense de Hematologia e Oncologia ( Site 1353)
state: Santa Catarina
city: Sorocaba
country: Brazil
facility: Instituto de Ensino e Pesquisa ( Site 1355)
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 1352)
city: Sao Paulo
country: Brazil
facility: Hospital Samaritano De Sao Paulo ( Site 1367)
city: Sao Paulo
country: Brazil
facility: A. C. Camargo Cancer Center ( Site 1351)
city: Sao Paulo
country: Brazil
facility: IBCC - Núcleo de Pesquisa e Ensino ( Site 1366)
city: Calgary
country: Canada
facility: Arthur J.E. Child Comprehensive Cancer Centre ( Site 1413)
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute ( Site 1414)
state: Alberta
city: Vancouver
country: Canada
facility: BC Cancer Vancouver ( Site 1415)
state: British Columbia
city: Mississauga
country: Canada
facility: Trillium Health Partners - Credit Valley Hospital ( Site 1410)
state: Ontario
city: Chicoutimi
country: Canada
facility: CIUSSS- saguenay-Lac-Saint-Jean ( Site 1408)
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 1405)
state: Quebec
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal ( Site 1403)
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 1404)
state: Quebec
city: Temuco
country: Chile
facility: James Lind Centro de Investigacion del Cancer ( Site 1504)
state: Araucania
city: Santiago.
country: Chile
facility: Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1505)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile ( Site 1503)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill-Clinical Area ( Site 1501)
state: Region M. De Santiago
city: Hefei
country: China
facility: Second Affiliated hospital of Anhui Medical University-Oncology ( Site 1635)
state: Anhui
city: Beijing
country: China
facility: Beijing Obstetric and Gynecology Hospital ( Site 1653)
state: Beijing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital-Gynecological Oncology Surgery ( Site 1627)
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated hospital of Xiamen University-Obstetrics and gynecology department ( Site 1613)
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1634)
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center ( Site 1604)
state: Guangdong
city: Shantou
country: China
facility: Cancer Hospital of Shantou University Medical College ( Site 1642)
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated Hospital of Guangdong Medical University ( Site 1614)
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital-Gynecological oncology ( Site 1622)
state: Guangxi
city: Haikou
country: China
facility: Hainan General Hospital ( Site 1636)
state: Hainan
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital-Gynecological Radiotherapy Department ( Site 1652)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 1618)
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University ( Site 1640)
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1621)
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 1607)
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University-Gynecology ( Site 1603)
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 1623)
state: Hunan
city: Nanjing
country: China
facility: Nanjing First Hospital ( Site 1649)
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Maternal and Child Health Hospital-Oncology Department ( Site 1625)
state: Jiangxi
city: Linyi
country: China
facility: LinYi Cancer Hospital-Gastrology department ( Site 1630)
state: Shandong
city: Shanghai
country: China
facility: Obstetrics & Gynecology Hospital of Fudan University ( Site 1617)
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 1626)
state: Shanghai
city: Chengdu
country: China
facility: West China Second University Hospital, Sichuan University ( Site 1602)
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Cancer hospital-Oncology ( Site 1650)
state: Sichuan
city: Urumqi
country: China
facility: Xinjiang Medical University Cancer Hospital - Urumqi ( Site 1648)
state: Xinjiang
city: Kunming
country: China
facility: Yunnan Province Cancer Hospital-Gynecology Department ( Site 1641)
state: Yunnan
city: Hangzhou
country: China
facility: The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 1609)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital-Oncology ( Site 1601)
state: Zhejiang
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province ( Site 1633)
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University ( Site 1615)
state: Zhejiang
city: Brno
country: Czechia
facility: Fakultní Nemocnice Brno-Gynekologicko-porodnicka klinika ( Site 1704)
state: Brno-mesto
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 1703)
state: Moravskoslezsky Kraj
city: Nový Jiín
country: Czechia
facility: Nemocnice AGEL Novy Jicin a.s.-Oddeleni radioterapie a onkologie ( Site 1706)
state: Novy Jicin
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1702)
state: Olomoucky Kraj
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady ( Site 1707)
state: Praha 10
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 1705)
state: Praha 2
city: Praha
country: Czechia
facility: Fakultni nemocnice Bulovka-Gynekologicko-porodnicka klinika ( Site 1701)
state: Praha 8
city: Copenhagen
country: Denmark
facility: Herlev and Gentofte Hospital-Department of Oncology ( Site 1801)
state: Hovedstaden
city: Copenhagen
country: Denmark
facility: Rigshospitalet-Dept. of Oncology ( Site 1803)
state: Hovedstaden
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Skejby ( Site 1802)
state: Midtjylland
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala ( Site 1901)
state: Pirkanmaa
city: Kuopio
country: Finland
facility: Kuopion Yliopistollinen Sairaala ( Site 1904)
state: Pohjois-Savo
city: Helsinki
country: Finland
facility: Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1902)
state: Uusimaa
city: Turku
country: Finland
facility: Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1903)
state: Varsinais-Suomi
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 2002)
state: Aquitaine
city: Chambray Les Tours
country: France
facility: ROC37 ( Site 2010)
state: Centre
city: Plerin
country: France
facility: Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 2001)
state: Cotes-d Armor
city: Besançon
country: France
facility: CHU Besançon ( Site 2009)
state: Doubs
city: Toulouse
country: France
facility: Institut Claudius Regaud ( Site 2006)
state: Haute-Garonne
city: Montpellier
country: France
facility: Institut Regional du Cancer Montpellier ( Site 2008)
state: Herault
city: Rennes
country: France
facility: Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 2003)
state: Ille-et-Vilaine
city: Lille
country: France
facility: Centre Oscar Lambret ( Site 2007)
state: Nord-Pas-de-Calais
city: Lyon Cedex08
country: France
facility: CENTRE LEON BERARD ( Site 2004)
state: Rhone-Alpes
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 2005)
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn ( Site 2107)
state: Baden-Wurttemberg
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim-Department of Obstetrics and Gynecology ( Site 2101)
state: Baden-Wurttemberg
city: Ravensburg
country: Germany
facility: MVZ für Hämatologie und Onkologie Ravensburg GmbH - Studienzentrum ( Site 2110)
state: Baden-Wurttemberg
city: Tübingen
country: Germany
facility: Universitaetsklinikum Tuebingen ( Site 2111)
state: Baden-Wurttemberg
city: Munich
country: Germany
facility: Klinikum der Universität München Großhadern-Klinik und Poliklinik für Frauenheilkunde und Geburtshi ( Site 2109)
state: Bayern
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur ( Site 2103)
state: Sachsen
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum ( Site 2102)
city: Patras
country: Greece
facility: Agios Andreas Hospital Patras ( Site 2201)
state: Achaia
city: Athens
country: Greece
facility: Aretaieio Hospital Oncology Unit ( Site 2206)
state: Attiki
city: Athens
country: Greece
facility: Metropolitan Hospital-2nd Oncology Dept ( Site 2202)
state: Attiki
city: Marousi
country: Greece
facility: Hygeia Hospital ( Site 2204)
state: Attiki
city: Cork
country: Ireland
facility: Cork University Hospital ( Site 2402)
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital ( Site 2403)
city: Dublin
country: Ireland
facility: St. James's Hospital-Cancer clinical trials office ( Site 2401)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Gyneco-oncology unit ( Site 2502)
city: Holon
country: Israel
facility: Edith Wolfson Medical Center ( Site 2501)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center ( Site 2503)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 2505)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 2504)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 2506)
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlin-SSD Oncologia medica Addarii ( Site 2603)
state: Emilia-Romagna
city: Aviano
country: Italy
facility: CRO-IRCCS ( Site 2609)
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: AOU Policlinico Umberto I ( Site 2606)
state: Lazio
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS ( Site 2607)
state: Lombardia
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 2605)
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 2610)
state: Milano
city: Candiolo
country: Italy
facility: Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'O-Day Hospital Oncologico Multidisciplin ( Site 2613)
state: Torino
city: Bari
country: Italy
facility: Instituto Tumori Giovanni Paolo II-ONCOLOGIA MEDICA ( Site 2604)
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia-Obstetrics anf gynecology ( Site 2611)
city: Milano
country: Italy
facility: Humanitas San Pio X Hospital ( Site 2614)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 2602)
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova ( Site 2612)
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2601)
city: Torino
country: Italy
facility: Ospedale Mauriziano-Ginecologia e Ostetricia ( Site 2608)
city: Nagoya
country: Japan
facility: Aichi Cancer Center ( Site 2714)
state: Aichi
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 2705)
state: Ehime
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 2709)
state: Ehime
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 2703)
state: Fukuoka
city: Otashi
country: Japan
facility: Gunma Prefectural Cancer Center ( Site 2708)
state: Gunma
city: Sapporo
country: Japan
facility: Hokkaido University Hospital ( Site 2707)
state: Hokkaido
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital ( Site 2713)
state: Ibaraki
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital ( Site 2712)
state: Iwate
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital ( Site 2701)
state: Niigata
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center ( Site 2710)
state: Saitama
city: Sunto-gun,
country: Japan
facility: Shizuoka Cancer Center ( Site 2716)
state: Shizuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital ( Site 2715)
state: Tokyo
city: Koto
country: Japan
facility: Cancer Institute Hospital of JFCR ( Site 2706)
state: Tokyo
city: Shinagawa
country: Japan
facility: Showa Medical University Hospital ( Site 2719)
state: Tokyo
city: Shinjuku
country: Japan
facility: Keio University Hospital ( Site 2702)
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 2711)
city: Kagoshima
country: Japan
facility: Kagoshima City Hospital ( Site 2717)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 2718)
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital-Obstetrics and Gynecology ( Site 3505)
state: Kyonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 3502)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 3503)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 3501)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 3504)
city: Kuala Lumpur
country: Malaysia
facility: Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 2803)
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre ( Site 2801)
city: Coyoacan
country: Mexico
facility: COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 2902)
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Higiea Oncologia ( Site 2905)
state: Distrito Federal
city: San Pedro Garza Garcia
country: Mexico
facility: CENTRO MEDICO ZAMBRANO HELLION-Centro de Cáncer de Mama ( Site 2901)
state: Nuevo Leon
city: San Pedro Garza García
country: Mexico
facility: Oncare - Unidad Valle ( Site 2906)
state: Nuevo Leon
city: Oaxaca de Juarez
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca ( Site 2907)
state: Oaxaca
city: Nijmegen
country: Netherlands
facility: Radboudumc-Medical Oncology ( Site 3003)
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC - locatie VUmc ( Site 3004)
state: Noord-Holland
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum-Medical Oncology ( Site 3002)
state: Zuid-Holland
city: Stavanger
country: Norway
facility: Stavanger Universitetssykehus ( Site 3103)
state: Rogaland
city: Tromsø
country: Norway
facility: Universitetssykehuset Nord-Norge HF ( Site 3101)
state: Troms
city: Kristiansand
country: Norway
facility: Sorlandet Sykehus Kristiansand ( Site 3104)
state: Vest-Agder
city: Oslo
country: Norway
facility: Oslo universitetssykehus, Radiumhospitalet ( Site 3102)
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 3201)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Site 3203)
state: Mazowieckie
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 3204)
state: Podlaskie
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie-Oddział Radioterapii i Onkologii Ginek ( Site 3202)
state: Wielkopolskie
city: Ponce
country: Puerto Rico
facility: Ad-Vance Medical Research-Research ( Site 3302)
city: San Juan
country: Puerto Rico
facility: Pan American Center for Oncology Trials - Ciudadela ( Site 3301)
city: San Juan
country: Puerto Rico
facility: UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 3304)
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore-Medical Oncology ( Site 3401)
state: Central Singapore
city: L Hospitalet
country: Spain
facility: Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 3608)
state: Barcelona
city: Girona
country: Spain
facility: Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 3606)
state: Gerona
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra ( Site 3603)
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre-Medical Oncology ( Site 3607)
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario La Paz-Oncología Médica ( Site 3604)
state: Madrid, Comunidad De
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncología-Oncologico ( Site 3605)
state: Valenciana, Comunitat
city: Valencia
country: Spain
facility: HOSPITAL CLINICO DE VALENCIA ( Site 3609)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 3602)
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia-Oncologia Medica ( Site 3601)
city: Lund
country: Sweden
facility: Skånes Universitetssjukhus Lund ( Site 3702)
state: Skane Lan
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna ( Site 3701)
state: Stockholms Lan
city: Basel
country: Switzerland
facility: University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 3808)
state: Basel-Stadt
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden-Medizin ( Site 3803)
state: Grisons
city: Bellinzona
country: Switzerland
facility: Ospedale Regionale Bellinzona e Valli ( Site 3802)
state: Ticino
city: Berne
country: Switzerland
facility: Inselspital Bern-Oncology ( Site 3801)
city: East Sussex
country: United Kingdom
facility: University Hospitals Sussex NHS Foundation Trust ( Site 4006)
state: Brighton And Hove
city: Derby
country: United Kingdom
facility: Royal Derby Hospital ( Site 4007)
state: Derbyshire
city: London
country: United Kingdom
facility: ROYAL MARSDEN HOSPITAL (CHELSEA)-Gynaecology Research Centre ( Site 4002)
state: England
city: Truro
country: United Kingdom
facility: The Royal Cornwall Hospital ( Site 4009)
state: England
city: London
country: United Kingdom
facility: University College London Hospital-Cancer Clinical Trials Unit ( Site 4004)
state: London, City Of
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 4008)
state: London, City Of
city: London
country: United Kingdom
facility: Hammersmith Hospital ( Site 4001)
state: London, City Of
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre ( Site 4005)
state: Scotland
city: London
country: United Kingdom
facility: Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 4010)
state: Sutton
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust-Medical Oncology ( Site 4003)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: