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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)
Sponsor: Merck Sharp & Dohme LLC
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.
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)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
686
Start Date
2024-07-24
Completion Date
2028-06-15
Last Updated
2026-08-28
Healthy Volunteers
No
Conditions
Interventions
Sacituzumab Tirumotecan
IV infusion
Pemetrexed
IV infusion
Tisotumab Vedotin
IV infusion
Topotecan
IV infusion
Vinorelbine
IV infusion
Gemcitabine
IV infusion
Irinotecan
IV infusion
Locations (240)
USA Mitchell Cancer Institute-Clinical Trials ( Site 4126)
Mobile, Alabama, United States
Providence Alaska Medical Center ( Site 4137)
Anchorage, Alaska, United States
HonorHealth (HH) ( Site 8002)
Phoenix, Arizona, United States
Arizona Oncology Associates - HOPE ( Site 8001)
Tucson, Arizona, United States
Moores Cancer Center-Clinical Trials Office - Gynecological Oncology ( Site 4125)
La Jolla, California, United States
UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4105)
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian ( Site 4104)
Newport Beach, California, United States
Mount Sinai Comprehensive Cancer Center ( Site 4143)
Miami Beach, Florida, United States
Advent Health ( Site 4140)
Orlando, Florida, United States
Florida Cancer Specialists East ( Site 7001)
West Palm Beach, Florida, United States
Northside Hospital ( Site 4127)
Atlanta, Georgia, United States
Georgia Cancer Center at Augusta University ( Site 4112)
Augusta, Georgia, United States
Lewis Cancer and Research Pavilion ( Site 4114)
Savannah, Georgia, United States
University Medical Center New Orleans ( Site 4132)
New Orleans, Louisiana, United States
Willis Knighton Medical Center ( Site 4101)
Shreveport, Louisiana, United States
The Center of Hope ( Site 4106)
Reno, Nevada, United States
Holy Name Medical Center ( Site 4117)
Teaneck, New Jersey, United States
Optimum Clinical Research Group ( Site 4138)
Albuquerque, New Mexico, United States
Perlmutter Cancer Center NYU Langone Hospital - Long Island ( Site 4145)
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 4121)
New York, New York, United States
Duke Cancer Institute ( Site 4120)
Durham, North Carolina, United States
University of Cincinnati Medical Center ( Site 4128)
Cincinnati, Ohio, United States
The Ohio State University ( Site 4103)
Hilliard, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research ( Site 4116)
Tulsa, Oklahoma, United States
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)
Eugene, Oregon, United States
Legacy Good Samaritan Medical Center-Oncology Clinical Research ( Site 4115)
Portland, Oregon, United States
Sidney Kimmel Cancer Center - Jefferson Health ( Site 4142)
Philadelphia, Pennsylvania, United States
Asplundh Cancer Pavilion ( Site 4113)
Willow Grove, Pennsylvania, United States
The West Clinic, PLLC dba West Cancer Center ( Site 4108)
Germantown, Tennessee, United States
Texas Oncology - Central/South Texas ( Site 8010)
Austin, Texas, United States
Texas Oncology - DFW ( Site 8003)
Fort Worth, Texas, United States
Houston Methodist Hospital OB/GYN ( Site 4102)
Houston, Texas, United States
Texas Oncology - San Antonio ( Site 8006)
San Antonio, Texas, United States
Texas Oncology - Northeast Texas ( Site 8009)
Tyler, Texas, United States
Texas Oncology - Gulf Coast ( Site 8008)
Webster, Texas, United States
University of Virginia Cancer Center ( Site 4123)
Charlottesville, Virginia, United States
Inova Schar Cancer Institute ( Site 4139)
Fairfax, Virginia, United States
Swedish Medical Center-Swedish Cancer Institute ( Site 4134)
Seattle, Washington, United States
Hospital Británico de Buenos Aires-Oncology ( Site 0102)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0107)
Mar del Plata, Buenos Aires, Argentina
Instituto de Oncología Angel H. Roffo ( Site 0103)
Buenos Aires, Buenos Aires F.D., Argentina
Instituto Alexander Fleming ( Site 0108)
Buenos Aires, Buenos Aires F.D., Argentina
Sanatorio Allende - Cerro-Oncology ( Site 0106)
Córdoba, Córdoba Province, Argentina
Hospital Aleman-Oncology ( Site 0100)
Buenos Aires, Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0109)
CABA, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0104)
La Rioja, Argentina
Blacktown Hospital ( Site 3006)
Sydney, New South Wales, Australia
Campbelltown Hospital-Macarthur Cancer Therapy Centre Medical Oncology ( Site 3000)
Sydney, New South Wales, Australia
Royal Brisbane and Women's Hospital ( Site 3001)
Herston, Queensland, Australia
Monash Health-Oncology Research ( Site 3002)
Clayton, Victoria, Australia
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 3005)
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital ( Site 3003)
Nedlands, Western Australia, Australia
Medizinische Universität Graz-Abteilung für Gynäkologie / Onkologie ( Site 1003)
Graz, Styria, Austria
Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 1000)
Innsbruck, Tyrol, Austria
Kepler Universitätsklinikum-Department for Oncology and Hematology ( Site 1002)
Linz, Upper Austria, Austria
Medizinische Universität Wien ( Site 1001)
Vienna, Austria
AZORG Campus Aalst-Moorselbaan ( Site 2905)
Aalst, Oost-Vlaanderen, Belgium
UZ Gent-Medical oncology ( Site 2901)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven-Gynecologic Oncology ( Site 2900)
Leuven, Vlaams-Brabant, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman-Medical Oncology ( Site 2904)
Belgium, Wallonne, Region, Belgium
CHU UCL Namur/Site Sainte Elisabeth-Trial Office ( Site 2902)
Namur, Belgium
Instituto do Câncer e Transplante de Curitiba ( Site 0205)
Curitiba, Paraná, Brazil
Hospital Moinhos de Vento-Centro de Pesquisa Clínica ( Site 0204)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital do Câncer Mãe de Deus ( Site 0201)
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Hematologia e Oncologia ( Site 0203)
Joinville, Santa Catarina, Brazil
IBCC - Instituto Brasileiro de Controle do Câncer-Centro de Pesquisa Clínica ( Site 0200)
São Paulo, São Paulo, Brazil
Americas Centro de Oncologia Integrado ( Site 0202)
Rio de Janeiro, Brazil
Hospital Paulistano ( Site 0209)
São Paulo, Brazil
MBAL Uni Hospital-Department of Medical Oncology ( Site 1104)
Panagyurishte, Pazardzhik, Bulgaria
MHAT - Heart and Brain ( Site 1100)
Pleven, Bulgaria
Complex Oncology Center - Plovdiv EOOD ( Site 1102)
Plovdiv, Bulgaria
BC Cancer Kelowna ( Site 4007)
Kelowna, British Columbia, Canada
BC Cancer Surrey ( Site 4006)
Surrey, British Columbia, Canada
BC Cancer Victoria ( Site 4008)
Victoria, British Columbia, Canada
Royal Victoria Regional Health Centre ( Site 4009)
Barrie, Ontario, Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 4003)
Hamilton, Ontario, Canada
Centre Hospitalier de l'Université de Montréal ( Site 4001)
Montreal, Quebec, Canada
McGill University Health Centre ( Site 4000)
Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 4002)
Québec, Quebec, Canada
FALP-UIDO ( Site 0300)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 0302)
Santiago, Region M. de Santiago, Chile
ONCOCENTRO APYS-ACEREY ( Site 0303)
Viña del Mar, Valparaiso, Chile
Anhui Provincial Cancer Hospital-Gynecological Oncology ( Site 5040)
Hefei, Anhui, China
Anhui Provincial Hospital ( Site 5011)
Hefei, Anhui, China
Beijing Peking Union Medical College Hospital ( Site 5045)
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital ( Site 5003)
Chongqing, Chongqing Municipality, China
Fujian Provincial Cancer Hospial ( Site 5012)
Fuzhou, Fujian, China
The First Affiliated hospital of Xiamen University-Obstetrics and gynecology department ( Site 5027)
Xiamen, Fujian, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 5001)
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center-Internal medicine ( Site 5006)
Guangzhou, Guangdong, China
Affiliated Hospital of Guangdong Medical University ( Site 5004)
Zhanjiang, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 5016)
Nanning, Guangxi, China
Hainan General Hospital ( Site 5032)
Haikou, Hainan, China
Harbin Medical University Cancer Hospital ( Site 5010)
Harbin, Heilongjiang, China
The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 5041)
Xinxiang, Henan, China
Henan Cancer Hospital ( Site 5026)
Zhengzhou, Henan, China
Wuhan Union Hospital ( Site 5020)
Wuhan, Hubei, China
Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 5019)
Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 5021)
Changsha, Hunan, China
Xiangya Hospital Central South University ( Site 5009)
Changsha, Hunan, China