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)
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)
8 other identifiers
interventional
686
31 countries
234
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2024
Typical duration for phase_3
234 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2024
CompletedFirst Posted
Study publicly available on registry
June 14, 2024
CompletedStudy Start
First participant enrolled
July 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 15, 2028
May 27, 2026
May 1, 2026
3.9 years
June 10, 2024
May 25, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Objective Response Rate (ORR) in Sacituzumab Tirumotecan Run-in
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Up to approximately 46 months
Number of Participants Experiencing One or More Adverse Events (AEs) in Sacituzumab Tirumotecan Run-in
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Up to approximately 46 months
Number of Participants Discontinuing Study Treatment Due to an AE in Sacituzumab Tirumotecan Run-in
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Up to approximately 46 months
Overall Survival (OS) in Phase 3 Portion
OS is defined as the time from randomization to death due to any cause.
Up to approximately 35 months
Secondary Outcomes (9)
Progression-free Survival (PFS) in Phase 3 Portion
Up to approximately 35 months
ORR in Phase 3 Portion
Up to approximately 35 months
Duration of Response (DOR) in Phase 3 Portion
Up to approximately 35 months
Number of Participants Experiencing One or More AEs in Phase 3 Portion
Up to approximately 46 months
Number of Participants Discontinuing Study Treatment Due to an AE in Phase 3 Portion
Up to approximately 46 months
- +4 more secondary outcomes
Study Arms (2)
Sacituzumab Tirumotecan
EXPERIMENTALParticipants will receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) via intravenous (IV) infusion until progressive disease or discontinuation.
Treatment of Physician's Choice (TPC)
ACTIVE COMPARATORAt the physician's discretion, participants will receive 500 mg/m\^2 of pemetrexed on day 1 of every 3-week cycle via IV infusion OR 2 mg/kg of tisotumab vedotin on day 1 of every 3-week cycle via IV infusion OR 1 mg/m\^2 (or 1.25 mg/m\^2 if tolerating well) topotecan on days 1, 2, 3, 4, and 5 of every 3-week cycle via IV infusion OR 30 mg/m\^2 of vinorelbine on days 1 and 8 of every 3-week cycle via IV infusion OR 1000 mg/m\^2 of gemcitabine on day 1 and 8 of every 3-week cycle via IV infusion OR 100 mg/m\^2 (or 125 mg/m\^2 if tolerating well) of irinotecan on days 1, 8, 15, and 22 of every 6 week cycle via IV infusion, until progressive disease or discontinuation.
Interventions
IV infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 other histological subtypes of cervical cancer apart from squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (eg, carcinosarcoma), or has a diagnosis of nonepithelial cancer (eg, sarcoma, neuroendocrine tumors) of the cervix.
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck Sharp & Dohme LLClead
- GOG Foundationcollaborator
- European Network of Gynaecological Oncological Trial Groups (ENGOT)collaborator
Study Sites (240)
USA Mitchell Cancer Institute-Clinical Trials ( Site 4126)
Mobile, Alabama, 36604, United States
Providence Alaska Medical Center ( Site 4137)
Anchorage, Alaska, 99508, United States
HonorHealth (HH) ( Site 8002)
Phoenix, Arizona, 85016, United States
Arizona Oncology Associates - HOPE ( Site 8001)
Tucson, Arizona, 85711, United States
Moores Cancer Center-Clinical Trials Office - Gynecological Oncology ( Site 4125)
La Jolla, California, 92093, United States
UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4105)
Los Angeles, California, 90095, United States
Hoag Memorial Hospital Presbyterian ( Site 4104)
Newport Beach, California, 92663, United States
Mount Sinai Braman Comprehensive Cancer Center ( Site 4143)
Miami Beach, Florida, 33140, United States
Advent Health ( Site 4140)
Orlando, Florida, 32804, United States
Florida Cancer Specialists East ( Site 7001)
West Palm Beach, Florida, 33401, United States
Northside Hospital ( Site 4127)
Atlanta, Georgia, 30342, United States
Georgia Cancer Center at Augusta University ( Site 4112)
Augusta, Georgia, 30912, United States
Lewis Cancer and Research Pavilion ( Site 4114)
Savannah, Georgia, 31405, United States
University Medical Center New Orleans ( Site 4132)
New Orleans, Louisiana, 70112, United States
Willis Knighton Medical Center ( Site 4101)
Shreveport, Louisiana, 71103, United States
The Center of Hope ( Site 4106)
Reno, Nevada, 89511, United States
Holy Name Medical Center ( Site 4117)
Teaneck, New Jersey, 07666, United States
Optimum Clinical Research Group ( Site 4138)
Albuquerque, New Mexico, 87109, United States
Perlmutter Cancer Center NYU Langone Hospital - Long Island ( Site 4145)
Mineola, New York, 11501, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 4121)
New York, New York, 10016, United States
Duke Cancer Institute ( Site 4120)
Durham, North Carolina, 27710, United States
University of Cincinnati Medical Center ( Site 4128)
Cincinnati, Ohio, 45219, United States
The Ohio State University ( Site 4103)
Hilliard, Ohio, 43026, United States
Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research ( Site 4116)
Tulsa, Oklahoma, 74146, United States
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)
Eugene, Oregon, 97401, United States
Legacy Good Samaritan Medical Center-Oncology Clinical Research ( Site 4115)
Portland, Oregon, 97210, United States
Sidney Kimmel Cancer Center - Jefferson Health ( Site 4142)
Philadelphia, Pennsylvania, 19107, United States
Asplundh Cancer Pavilion ( Site 4113)
Willow Grove, Pennsylvania, 19090, United States
The West Clinic, PLLC dba West Cancer Center ( Site 4108)
Germantown, Tennessee, 38138, United States
Texas Oncology - Central/South Texas ( Site 8010)
Austin, Texas, 78731, United States
Texas Oncology - DFW ( Site 8003)
Fort Worth, Texas, 76104, United States
Houston Methodist Hospital OB/GYN ( Site 4102)
Houston, Texas, 77030, United States
Texas Oncology - San Antonio ( Site 8006)
San Antonio, Texas, 78240, United States
Texas Oncology - Northeast Texas ( Site 8009)
Tyler, Texas, 75702, United States
Texas Oncology - Gulf Coast ( Site 8008)
Webster, Texas, 77598, United States
University of Virginia Cancer Center ( Site 4123)
Charlottesville, Virginia, 22908, United States
Inova Schar Cancer Institute ( Site 4139)
Fairfax, Virginia, 22031-4867, United States
Swedish Medical Center-Swedish Cancer Institute ( Site 4134)
Seattle, Washington, 98104, United States
Hospital Británico de Buenos Aires-Oncology ( Site 0102)
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0107)
Mar del Plata, Buenos Aires, B7600FZO, Argentina
Instituto de Oncología Angel H. Roffo ( Site 0103)
Buenos Aires, Buenos Aires F.D., C1417, Argentina
Instituto Alexander Fleming ( Site 0108)
Buenos Aires, Buenos Aires F.D., C1426ANZ, Argentina
Sanatorio Allende - Cerro-Oncology ( Site 0106)
Córdoba, Córdoba Province, 5000, Argentina
Hospital Aleman-Oncology ( Site 0100)
Buenos Aires, C1118AAT, Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0109)
CABA, C1431FWO, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0104)
La Rioja, F5300COE, Argentina
Blacktown Hospital ( Site 3006)
Sydney, New South Wales, 2148, Australia
Campbelltown Hospital-Macarthur Cancer Therapy Centre Medical Oncology ( Site 3000)
Sydney, New South Wales, 2560, Australia
Royal Brisbane and Women's Hospital ( Site 3001)
Herston, Queensland, 4029, Australia
Monash Health-Oncology Research ( Site 3002)
Clayton, Victoria, 3168, Australia
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 3005)
Melbourne, Victoria, 3000, Australia
Sir Charles Gairdner Hospital ( Site 3003)
Nedlands, Western Australia, 6009, Australia
Medizinische Universität Graz-Abteilung für Gynäkologie / Onkologie ( Site 1003)
Graz, Styria, 8036, Austria
Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 1000)
Innsbruck, Tyrol, 6020, Austria
Kepler Universitätsklinikum-Department for Oncology and Hematology ( Site 1002)
Linz, Upper Austria, 4020, Austria
Medizinische Universität Wien ( Site 1001)
Vienna, 1090, Austria
AZORG Campus Aalst-Moorselbaan ( Site 2905)
Aalst, Oost-Vlaanderen, 9300, Belgium
UZ Gent-Medical oncology ( Site 2901)
Ghent, Oost-Vlaanderen, 9000, Belgium
UZ Leuven-Gynecologic Oncology ( Site 2900)
Leuven, Vlaams-Brabant, 3000, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman-Medical Oncology ( Site 2904)
Belgium, Wallonne, Region, 4000, Belgium
CHU UCL Namur/Site Sainte Elisabeth-Trial Office ( Site 2902)
Namur, 5000, Belgium
Instituto do Câncer e Transplante de Curitiba ( Site 0205)
Curitiba, Paraná, 80510130, Brazil
Hospital Moinhos de Vento-Centro de Pesquisa Clínica ( Site 0204)
Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
Hospital do Câncer Mãe de Deus ( Site 0201)
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Centro de Hematologia e Oncologia ( Site 0203)
Joinville, Santa Catarina, 89202-050, Brazil
IBCC - Instituto Brasileiro de Controle do Câncer-Centro de Pesquisa Clínica ( Site 0200)
São Paulo, São Paulo, 04014-002, Brazil
Americas Centro de Oncologia Integrado ( Site 0202)
Rio de Janeiro, 22775-001, Brazil
Hospital Paulistano ( Site 0209)
São Paulo, 01321-001, Brazil
MBAL Uni Hospital-Department of Medical Oncology ( Site 1104)
Panagyurishte, Pazardzhik, 4500, Bulgaria
MHAT - Heart and Brain ( Site 1100)
Pleven, 5804, Bulgaria
Complex Oncology Center - Plovdiv EOOD ( Site 1102)
Plovdiv, 4004, Bulgaria
BC Cancer Kelowna ( Site 4007)
Kelowna, British Columbia, V1Y 5L3, Canada
BC Cancer Surrey ( Site 4006)
Surrey, British Columbia, V3V 1Z2, Canada
BC Cancer Victoria ( Site 4008)
Victoria, British Columbia, V8R 6V5, Canada
Royal Victoria Regional Health Centre ( Site 4009)
Barrie, Ontario, L4M 6M2, Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 4003)
Hamilton, Ontario, L8V 5C2, Canada
Centre Hospitalier de l'Université de Montréal ( Site 4001)
Montreal, Quebec, H2X 0C1, Canada
McGill University Health Centre ( Site 4000)
Montreal, Quebec, H4A 3J1, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 4002)
Québec, Quebec, G1J 1Z4, Canada
FALP-UIDO ( Site 0300)
Santiago, Region M. de Santiago, 7500921, Chile
Pontificia Universidad Catolica de Chile ( Site 0302)
Santiago, Region M. de Santiago, 832000, Chile
ONCOCENTRO APYS-ACEREY ( Site 0303)
Viña del Mar, Valparaiso, 2520598, Chile
Anhui Provincial Cancer Hospital-Gynecological Oncology ( Site 5040)
Hefei, Anhui, 230000, China
Anhui Provincial Hospital ( Site 5011)
Hefei, Anhui, 230071, China
Beijing Peking Union Medical College Hospital ( Site 5045)
Beijing, Beijing Municipality, 100730, China
Chongqing University Cancer Hospital ( Site 5003)
Chongqing, Chongqing Municipality, 400030, China
Fujian Provincial Cancer Hospial ( Site 5012)
Fuzhou, Fujian, 350014, China
The First Affiliated hospital of Xiamen University-Obstetrics and gynecology department ( Site 5027)
Xiamen, Fujian, 361003, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 5001)
Guangzhou, Guangdong, 510000, China
Sun Yat-sen University Cancer Center-Internal medicine ( Site 5006)
Guangzhou, Guangdong, 511400, China
Affiliated Hospital of Guangdong Medical University ( Site 5004)
Zhanjiang, Guangdong, 524004, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 5016)
Nanning, Guangxi, 530200, China
Hainan General Hospital ( Site 5032)
Haikou, Hainan, 570311, China
Harbin Medical University Cancer Hospital ( Site 5010)
Harbin, Heilongjiang, 150000, China
The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 5041)
Xinxiang, Henan, 453100, China
Henan Cancer Hospital ( Site 5026)
Zhengzhou, Henan, 450008, China
Wuhan Union Hospital ( Site 5020)
Wuhan, Hubei, 430048, China
Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 5019)
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital ( Site 5021)
Changsha, Hunan, 410013, China
Xiangya Hospital Central South University ( Site 5009)
Changsha, Hunan, 410028, China
Jiangsu Province Hospital-Oncology Department ( Site 5018)
Nanjing, Jiangsu, 210036, China
Jiangxi Maternal and Child Health Hospital ( Site 5031)
Nanchang, Jiangxi, 330077, China
Jilin Province Tumor Hospital ( Site 5036)
Changchun, Jilin, 130000, China
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 5007)
Xi'an, Shaanxi, 710061, China
Shandong Cancer Hospital ( Site 5014)
Jinan, Shandong, 250117, China
LinYi Cancer Hospital-Gastrology department ( Site 5039)
Linyi, Shandong, 276000, China
Obstetrics & Gynecology Hospital of Fudan University ( Site 5015)
Shanghai, Shanghai Municipality, 200011, China
Shanxi Cancer Hospital ( Site 5043)
Taiyuan, Shanxi, 030000, China
West China Second University Hospital, Sichuan University ( Site 5017)
Chengdu, Sichuan, 610000, China
Sichuan Cancer hospital-Oncology ( Site 5030)
Chengdu, Sichuan, 610042, China
Yunnan Province Cancer Hospital-Gynecology Department ( Site 5005)
Kunming, Yunnan, 650107, China
Women s Hospital School of Medicine Zhejiang University ( Site 5022)
Hangzhou, Zhejiang, 310006, China
Zhejiang Cancer Hospital ( Site 5008)
Hangzhou, Zhejiang, 310022, China
The First Affiliated Hospital of Wenzhou Medical University ( Site 5033)
Wenzhou, Zhejiang, 325015, China
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0403)
Bogotá, Bogota D.C., 110131, Colombia
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0401)
Valledupar, Cesar Department, 200001, Colombia
Instituto Nacional De Cancerologia-Oncología Clínica ( Site 0404)
Bogota, Cundinamarca, 111151, Colombia
IMAT S.A.S ( Site 0402)
Montería, Departamento de Córdoba, 230002, Colombia
Oncologos del Occidente ( Site 0405)
Pereira, Risaralda Department, 660001, Colombia
Fundación Valle del Lili ( Site 0406)
Cali, Valle del Cauca Department, 760032, Colombia
Rigshospitalet-Dept. of Oncology ( Site 1300)
Copenhagen, Capital Region, 2100, Denmark
Aarhus Universitetshospital, Skejby ( Site 1301)
Aarhus, Central Jutland, 8200, Denmark
Odense Universitetshospital-Department of oncology ( Site 1302)
Odense C, Region Syddanmark, 5000, Denmark
Tampereen yliopistollinen sairaala-Gynecology and Obstetrics ( Site 1404)
Tampere, Pirkanmaa, 33520, Finland
Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1401)
Turku, Southwest Finland, 20520, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1400)
Helsinki, Uusimaa, 00029, Finland
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1503)
Bordeaux, Aquitaine, 33076, France
CENTRE LEON BERARD ( Site 1505)
Lyon Cedex08, Auvergne-Rhône-Alpes, 69373, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1508)
Clermont-Ferrand, Auvergne, 63011, France
Hopitaux Universitaires de Strasbourg ( Site 1501)
Strasbourg, Bas-Rhin, 67200, France
Institut Paoli-Calmettes ( Site 1504)
Marseille, Bouches-du-Rhone, 13009, France
Hôpital Privé Des Côtes d'Armor ( Site 1510)
Plérin, Cotes-d Armor, 22190, France
CHU Besançon ( Site 1507)
Besançon, Franche-Comte, 25030, France
Oncopole Claudius Regaud ( Site 1502)
Toulouse, Haute-Garonne, 31059, France
Institut Regional du Cancer Montpellier ( Site 1511)
Montpellier, Herault, 34298, France
Hôpital privé du Confluent SAS ( Site 1509)
Nantes, Loire-Atlantique, 44277, France
Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 1506)
Paris, 75020, France
Gustave Roussy ( Site 1512)
Villejuif, Île-de-France Region, 94805, France
Universitaetsklinikum Heidelberg Nationales Centrum fuer Tumorerkrankungen ( Site 1612)
Heidelberg, Baden-Wurttemberg, 69120, Germany
SLK-Kliniken Heilbronn ( Site 1617)
Heilbronn, Baden-Wurttemberg, 74078, Germany
Diakonie-Klinikum Schwaebisch-Hall gGmbH Frauenklinik ( Site 1614)
Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany
Klinikum der Universität München Großhadern-Klinik und Poliklinik für Frauenheilkunde und Geburtshi ( Site 1605)
Munich, Bavaria, 81377, Germany
Universitätsklinikum Marburg ( Site 1604)
Marburg, Hesse, 35043, Germany
Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1607)
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Gynäkologie und Gynäkologische Onko ( Site 1600)
Essen, North Rhine-Westphalia, 45136, Germany
Universitaetsklinikum Essen ( Site 1613)
Essen, North Rhine-Westphalia, 45147, Germany
Klinikum Worms ( Site 1619)
Worms, Rhineland-Palatinate, 67550, Germany
Universitaetsklinikum des Saarlandes ( Site 1618)
Homburg, Saarland, 66421, Germany
Universitaetsklinikum Hamburg-Eppendorf-Department of Gynecology ( Site 1611)
Hamburg, 20246, Germany
Aretaieio Hospital ( Site 1700)
Athens, Attica, 115 28, Greece
Mitera Hospital ( Site 1702)
Athens, Attica, 151 23, Greece
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1703)
Chaïdári, Attica, 124 62, Greece
Agios Andreas Hospital Patras ( Site 1701)
Patras, Peloponnese, 263 35, Greece
Cork University Hospital ( Site 1900)
Cork, T12 E8YV, Ireland
Mater Misericordiae University Hospital ( Site 1901)
Dublin, D07 R2WY, Ireland
St. James's Hospital-Cancer clinical trials office ( Site 1902)
Dublin, D08 E9P6, Ireland
Rambam Health Care Campus ( Site 2002)
Haifa, 3109601, Israel
Edith Wolfson Medical Center ( Site 2003)
Holon, 5810001, Israel
Hadassah Medical Center ( Site 2000)
Jerusalem, 9112001, Israel
Sheba Medical Center ( Site 2001)
Ramat Gan, 5265601, Israel
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlin-DEPARTMENT OF EXPERIMENTAL, DIAGNOSTIC ( Site 2105)
Bologna, Emilia-Romagna, 40138, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 2107)
Milan, Lombardy, 20133, Italy
Ospedale Humanitas San Pio X ( Site 2113)
Milan, Lombardy, 20159, Italy
Fondazione IRCCS San Gerardo dei Tintori-Oncologia ( Site 2111)
Monza, Lombardy, 20900, Italy
Humanitas University ( Site 2112)
Rozzano, Milano, 20089, Italy
Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 2100)
Turin, Piedmont, 10128, Italy
Azienda Ospedaliera Spedali Civili di Brescia-Obstetrics anf gynecology ( Site 2110)
Brescia, 25123, Italy
Ospedale Cannizzaro ( Site 2104)
Catania, 95126, Italy
Ospedale San Raffaele. ( Site 2106)
Milan, 20132, Italy
Istituto Europeo di Oncologia IRCCS ( Site 2108)
Milan, 20141, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2103)
Naples, 80131, Italy
Istituto Oncologico Veneto IRCCS ( Site 2109)
Padova, 35128, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2102)
Roma, 00168, Italy
Aichi Cancer Center ( Site 5110)
Nagoya, Aichi-ken, 464-8681, Japan
National Cancer Center Hospital East ( Site 5113)
Kashiwa, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center ( Site 5109)
Matsuyama, Ehime, 791-0280, Japan
Ehime University Hospital ( Site 5102)
Tōon, Ehime, 791-0295, Japan
Kurume University Hospital ( Site 5105)
Kurume, Fukuoka, 830-0011, Japan
Gunma Prefectural Cancer Center ( Site 5116)
Ohta, Gunma, 373-8550, Japan
Hokkaido University Hospital ( Site 5106)
Sapporo, Hokkaido, 060-8648, Japan
University of Tsukuba Hospital ( Site 5114)
Tsukuba, Ibaraki, 305-8576, Japan
Iwate Medical University Hospital ( Site 5112)
Shiwa-gun, Iwate, 028-3695, Japan
Saitama Medical University International Medical Center ( Site 5117)
Hidaka, Saitama, 350-1298, Japan
Shizuoka Cancer Center ( Site 5107)
Sunto-gun,, Shizuoka, 411-8777, Japan
National Cancer Center Hospital ( Site 5108)
Chūō, Tokyo, 104-0045, Japan
Cancer Institute Hospital of JFCR ( Site 5111)
Koto, Tokyo, 135-8550, Japan
The Jikei University Hospital ( Site 5118)
Minato, Tokyo, 105-8471, Japan
Keio University Hospital ( Site 5101)
Shinjyuku, Tokyo, 160-8582, Japan
National Hospital Organization Kyushu Cancer Center ( Site 5104)
Fukuoka, 811-1395, Japan
Kagoshima City Hospital ( Site 5115)
Kagoshima, 890-8760, Japan
Niigata Cancer Center Hospital ( Site 5100)
Niigata, 951-8566, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 5103)
Osaka, 541-8567, Japan
University Malaya Medical Centre ( Site 3102)
Lembah Pantai, Kuala Lumpur, 59100, Malaysia
Sunway Medical Centre ( Site 3105)
Petaling Jaya, Selangor, 47500, Malaysia
Pantai Hospital Kuala Lumpur ( Site 3100)
Kuala Lumpur, 59100, Malaysia
Penang Adventist Hospital ( Site 3101)
Pulau Pinang, 10350, Malaysia
CENEIT Oncologicos ( Site 0507)
Mexico City, Mexico City, 03100, Mexico
Oncare - Unidad Valle ( Site 0509)
San Pedro Garza García, Nuevo León, 66220, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 0505)
Oaxaca City, Oaxaca, 68020, Mexico
Centro de Investigación Oncológica Galerías SC ( Site 0508)
Aguascalientes, 20124, Mexico
Centro de Atención e Investigación Cardiovascular del Potosí ( Site 0506)
San Luis Potosí City, 78200, Mexico
Radboudumc-Medical Oncology ( Site 2202)
Nijmegen, Gelderland, 6525 GA, Netherlands
Catharina Ziekenhuis-Oncology ( Site 2203)
Eindhoven, North Brabant, 5623 EJ, Netherlands
Amsterdam UMC, locatie VUmc ( Site 2201)
Amsterdam, North Holland, 1081 HV, Netherlands
Erasmus Medisch Centrum-Medical Oncology ( Site 2200)
Rotterdam, South Holland, 3015 GD, Netherlands
University Medical Center Groningen ( Site 2204)
Groningen, 9713 GZ, Netherlands
Oslo universitetssykehus, Radiumhospitalet ( Site 2300)
Oslo, 0379, Norway
Uniwersytecki Szpital Kliniczny w Poznaniu-Klinika Ginekologii Onkologicznej ( Site 2404)
Poznan, Greater Poland Voivodeship, 60-569, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Site 2400)
Warsaw, Masovian Voivodeship, 02-781, Poland
Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2402)
Bialystok, Podlaskie Voivodeship, 15-027, Poland
UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 0601)
San Juan, 00935, Puerto Rico
National University Hospital ( Site 3301)
Singapore, Central Singapore, 119228, Singapore
National Cancer Centre Singapore ( Site 3300)
Singapore, Central Singapore, 168583, Singapore
Seoul National University Hospital ( Site 3403)
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System ( Site 3402)
Seoul, 03722, South Korea
Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 3401)
Seoul, 05505, South Korea
Samsung Medical Center ( Site 3400)
Seoul, 06351, South Korea
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2509)
Barcelona, Catalonia, 08036, Spain
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2508)
L'Hospitalet de Llobregat, Catalonia, 08908, Spain
Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 2507)
Girona, Gerona, 17007, Spain
Clinica Universidad de Navarra ( Site 2510)
Madrid, Madrid, Comunidad de, 28027, Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2502)
Madrid, Madrid, Comunidad de, 28034, Spain
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2506)
Madrid, Madrid, Comunidad de, 28041, Spain
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2503)
Valencia, Valenciana, Comunitat, 46009, Spain
HOSPITAL CLINICO DE VALENCIA ( Site 2505)
Valencia, Valenciana, Comunitat, 46010, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2500)
Barcelona, 08035, Spain
Hospital Universitario Reina Sofia-Oncologia Medica ( Site 2501)
Córdoba, 14004, Spain
Hospital Universitario La Paz-Oncología Médica ( Site 2504)
Madrid, 28046, Spain
Skånes Universitetssjukhus Lund-Department of Hematology ( Site 2602)
Lund, Skåne County, 221 85, Sweden
Karolinska Universitetssjukhuset Solna ( Site 2601)
Stockholm, Stockholm County, 171 64, Sweden
Akademiska sjukhuset ( Site 2603)
Uppsala, Uppsala County, 751 85, Sweden
Universitetssjukhuset i Linköping ( Site 2600)
Linköping, Östergötland County, 581 85, Sweden
University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 2701)
Basel, Canton of Basel-City, 4031, Switzerland
Inselspital Bern-Oncology ( Site 2700)
Bern, 3010, Switzerland
ROYAL MARSDEN HOSPITAL (CHELSEA)-Gynaecology Research Centre ( Site 2807)
London, England, SW10 9NH, United Kingdom
Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 2801)
Sutton, England, SM2 5PT, United Kingdom
Gartnavel General Hospital-Clinical Trials Unit ( Site 2800)
Glasgow, Glasgow City, G12 0YN, United Kingdom
University College London Hospital ( Site 2805)
London, London, City of, NW1 2PG, United Kingdom
St James's University Hospital ( Site 2804)
Leeds, LS9 7TF, United Kingdom
The Christie NHS Foundation Trust-Research and Development ( Site 2802)
Manchester, m20 4bx, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2024
First Posted
June 14, 2024
Study Start
July 24, 2024
Primary Completion (Estimated)
June 15, 2028
Study Completion (Estimated)
June 15, 2028
Last Updated
May 27, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf