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A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body. Researchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: * About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and * If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment
Official title: A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1023
Start Date
2026-01-19
Completion Date
2031-10-29
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab
Intravenous (IV) Infusion
Sacituzumab Tirumotecan
IV Infusion
Bevacizumab
IV Infusion
Paclitaxel
IV Infusion
Cisplatin
IV Infusion
Carboplatin
IV Infusion
Rescue Medications
Participants will receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent, prophylactic steroid mouthwash (dexamethasone or equivalent), and granulocyte colony-stimulating factor (G-CSF).
Locations (191)
University of Alabama- Birmingham ( Site 5015)
Birmingham, Alabama, United States
Alaska Womens Cancer Care ( Site 5046)
Anchorage, Alaska, United States
CHAO Family Comprehensive Cancer Center and Ambulatory Care ( Site 5037)
Irvine, California, United States
Moores Cancer Center-Clinical Trials Office - Gynecological Oncology ( Site 5000)
La Jolla, California, United States
University of California Irvine Medical Center ( Site 6006)
Orange, California, United States
Florida Cancer Specialists - South ( Site 7001)
Fort Myers, Florida, United States
Mount Sinai Braman Comprehensive Cancer Center ( Site 5043)
Miami Beach, Florida, United States
Mount Sinai Comprehensive Cancer Center ( Site 6000)
Miami Beach, Florida, United States
Moffit Cancer Center ( Site 5026)
Tampa, Florida, United States
Florida Cancer Specialists - East ( Site 7000)
West Palm Beach, Florida, United States
Winship Cancer Institute of Emory University ( Site 5005)
Atlanta, Georgia, United States
Nancy N. & J.C. Lewis Cancer and Research Pavillion - Research Department ( Site 6005)
Savannah, Georgia, United States
TRIALS 365 ( Site 6008)
Shreveport, Louisiana, United States
Maryland Oncology Hematology (MOH) ( Site 8001)
Columbia, Maryland, United States
Minnesota Oncology Hematology, PA ( Site 8003)
Edina, Minnesota, United States
Nebraska Methodist Hospital ( Site 5010)
Omaha, Nebraska, United States
Women's Cancer Center of Nevada ( Site 6011)
Las Vegas, Nevada, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 5039)
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6009)
New York, New York, United States
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 5020)
Cincinnati, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6002)
Columbus, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6001)
Tulsa, Oklahoma, United States
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)
Eugene, Oregon, United States
Honickman Center ( Site 5033)
Philadelphia, Pennsylvania, United States
Asplundh Cancer Pavilion ( Site 5002)
Willow Grove, Pennsylvania, United States
Women & Infants Hospital ( Site 6003)
Providence, Rhode Island, United States
University of Tennessee Medical Center ( Site 6012)
Knoxville, Tennessee, United States
Texas Oncology - DFW ( Site 8005)
Fort Worth, Texas, United States
Houston Methodist Hospital-Obstetrics and Gynecology ( Site 6010)
Houston, Texas, United States
Texas Oncology-The Woodlands ( Site 8000)
The Woodlands, Texas, United States
Texas Oncology - Northeast Texas ( Site 8002)
Tyler, Texas, United States
University of Virginia Cancer Center ( Site 5044)
Charlottesville, Virginia, United States
University of Virginia Cancer Center ( Site 6014)
Charlottesville, Virginia, United States
Inova Schar Cancer Institute ( Site 5045)
Fairfax, Virginia, United States
Centro de Oncología e Investigación de Buenos Aires ( Site 0107)
Berazategui, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0105)
Mar del Plata, Buenos Aires, Argentina
Fundación Respirar ( Site 0101)
Belgrano, Buenos Aires F.D., Argentina
Instituto Misionero del Cancer ( Site 0112)
Posadas, Misiones Province, Argentina
Instituto de Oncologia de Rosario ( Site 0104)
Rosario, Santa Fe Province, Argentina
Hospital Provincial del Centenario ( Site 0106)
Rosario, Santa Fe Province, Argentina
Centro Medico Privado CEMAIC ( Site 0102)
Córdoba, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0111)
La Rioja, Argentina
Medizinische Universitaet Wien ( Site 0302)
Vienna, State of Vienna, Austria
Medizinische Universitat Graz ( Site 0303)
Graz, Styria, Austria
Medizinische Universitaet Innsbruck ( Site 0301)
Innsbruck, Tyrol, Austria
Uniklinikum Salzburg Landeskrankenhaus ( Site 0304)
Salzburg, Austria
Antwerp University Hospital ( Site 0407)
Edegem, Antwerpen, Belgium
Cliniques Universitaires Saint-Luc ( Site 0402)
Brussels, Bruxelles-Capitale, Region de, Belgium
Grand Hopital de Charleroi ( Site 0404)
Charleroi, Hainaut, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0403)
Liège, Liege, Belgium
UZ Gent ( Site 0406)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0401)
Leuven, Vlaams-Brabant, Belgium
Hospital Araújo Jorge ( Site 0518)
Goiânia, Goiás, Brazil
Liga Norte Riograndense Contra o Câncer ( Site 0513)
Natal, Rio Grande do Norte, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0514)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital São Lucas da PUCRS ( Site 0516)
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0511)
Barretos, São Paulo, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0512)
São José do Rio Preto, São Paulo, Brazil
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0517)
São Paulo, São Paulo, Brazil
Instituto Nacional de Câncer - INCA ( Site 0515)
Rio de Janeiro, Brazil
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0609)
Calgary, Alberta, Canada
Cross Cancer Institute ( Site 0614)
Edmonton, Alberta, Canada
Nova Scotia Cancer Centre ( Site 0617)
Halifax, Nova Scotia, Canada
London Health Sciences Centre ( Site 0613)
London, Ontario, Canada
Sunnybrook Research Institute ( Site 0605)
Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0601)
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0616)
Montreal, Quebec, Canada
McGill University Health Centre ( Site 0602)
Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0611)
Québec, Quebec, Canada
CIUSSS de l Estrie Centre Hospitalier Universitaire de Sherbrooke ( Site 0604)
Sherbrooke, Quebec, Canada
CIDO SpA-Oncology ( Site 0708)
Temuco, Araucania, Chile
IC La Serena Research ( Site 0710)
La Serena, Coquimbo Region, Chile
Fundación Arturo López Pérez ( Site 0701)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile-CICUC ( Site 0706)
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0702)
Santiago, Region M. de Santiago, Chile
ONCOCENTRO APYS-ACEREY ( Site 0703)
Viña del Mar, Valparaiso, Chile
Clinica Somer ( Site 0903)
Rionegro, Antioquia, Colombia
Centro Cancerológico del Caribe (CECAC) ( Site 0906)
Barranquilla, Atlántico, Colombia
Instituto Nacional De Cancerologia ( Site 0909)
Bogotá, Bogota D.C., Colombia
Oncomédica S.A.S ( Site 0905)
Montería, Departamento de Córdoba, Colombia
Oncólogos del Occidente S.A.S. ( Site 0908)
Pereira, Risaralda Department, Colombia
Fakultní Nemocnice Brno ( Site 1003)
Brno, Brno-mesto, Czechia
Nemocnice AGEL Novy Jicin a.s. ( Site 1004)
Nový Jičín, Moravian-Silesian Region, Czechia
Fakultni nemocnice Ostrava ( Site 1005)
Ostrava, Moravian-Silesian Region, Czechia
Fakultni nemocnice Kralovske Vinohrady ( Site 1002)
Prague, Praha 10, Czechia
Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 1001)
Prague, Czechia
Odense Universitetshospital-Department of oncology ( Site 1103)
Odense C, Region Syddanmark, Denmark
CHU Strasbourg-Hautepierre ( Site 1207)
Strasbourg, Alsace, France
Centre Hopitalier Lyon Sud ( Site 1206)
Pierre-Bénite, Auvergne-Rhône-Alpes, France
CHRU de Brest-Institut de cancérologie et d'Hématologie ( Site 1202)
Brest, Brittany Region, France
Centre François Baclesse ( Site 1201)
Caen, Calvados, France
Pôle Santé Léonard de Vinci ( Site 1209)
Chambray-lès-Tours, Centre-Val de Loire, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1204)
Bordeaux, Gironde, France
LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1203)
Toulouse, Haute-Garonne, France
Hopital Europeen Georges Pompidou ( Site 1210)
Paris, France
Universitaetsklinikum Jena ( Site 1303)
Jena, Thuringia, Germany
Charite Universitaetsmedizin Berlin - Campus-Virchow-Klinikum ( Site 1301)
Berlin, Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 1309)
Hamburg, Germany
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 1401)
Athens, Attica, Greece
Aretaieio Hospital Oncology Unit ( Site 1402)
Athens, Attica, Greece