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Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)
Sponsor: Merck Sharp & Dohme LLC
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.
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)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
710
Start Date
2023-12-06
Completion Date
2028-01-10
Last Updated
2026-08-28
Healthy Volunteers
No
Conditions
Interventions
Sacituzumab tirumotecan
4 mg/kg of sacituzumab tirumotecan by IV infusion
Doxorubicin
60 mg/m\^2 of doxorubicin by IV Infusion
Paclitaxel
80 mg/m\^2 of paclitaxel by IV infusion
Nab-paclitaxel
100 mg/m\^2 of nab-paclitaxel by IV infusion
Rescue medications
Participants will receive the following rescue medications per approved product label before sacituzumab tirumotecan infusion: Histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and steroid mouthwash (dexamethasone or equivalent).
Locations (242)
USA Mitchell Cancer Institute ( Site 4142)
Mobile, Alabama, United States
Alaska Womens Cancer Care ( Site 4122)
Anchorage, Alaska, United States
HonorHealth (HH) ( Site 8000)
Phoenix, Arizona, United States
Arizona Oncology Associates - HOPE ( Site 8002)
Tucson, Arizona, United States
UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4131)
Los Angeles, California, United States
California Pacific Medical Center - Van Ness Campus ( Site 4129)
San Francisco, California, United States
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 4114)
New Haven, Connecticut, United States
MedStar Washington Hospital Center ( Site 4108)
Washington D.C., District of Columbia, United States
Mount Sinai Cancer Center ( Site 4117)
Miami Beach, Florida, United States
AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 4113)
Orlando, Florida, United States
Florida Cancer Specialists - East ( Site 7000)
West Palm Beach, Florida, United States
Northside Hospital ( Site 4112)
Atlanta, Georgia, United States
Augusta University ( Site 4116)
Augusta, Georgia, United States
Centricity Research Columbus Cancer Center ( Site 4154)
Columbus, Georgia, United States
NorthShore University HealthSystem - Evanston Hospital ( Site 4110)
Evanston, Illinois, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 4132)
Fort Wayne, Indiana, United States
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 4150)
Edgewood, Kentucky, United States
University Medical Center New Orleans ( Site 4133)
New Orleans, Louisiana, United States
TRIALS 365 ( Site 4105)
Shreveport, Louisiana, United States
University of Massachusetts Memorial Medical Center ( Site 4103)
Worcester, Massachusetts, United States
Washington University School of Medicine-Obstetrics & Gynecology ( Site 4146)
St Louis, Missouri, United States
The Center of Hope ( Site 4109)
Reno, Nevada, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 4118)
Hackensack, New Jersey, United States
Atlantic Health System Morristown Medical Center ( Site 4135)
Morristown, New Jersey, United States
Holy Name Medical Center ( Site 4115)
Teaneck, New Jersey, United States
New York - Presbyterian Brooklyn Methodist Hospital ( Site 4134)
Brooklyn, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 4156)
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center ( Site 4106)
New York, New York, United States
Icahn School of Medicine at Mount Sinai-Department of Obstetrics, Gynecology, and Reproductive Scie ( Site 4128)
New York, New York, United States
Good Samaritan Hospital Medical Center ( Site 4139)
West Islip, New York, United States
Duke Cancer Institute ( Site 4120)
Durham, North Carolina, United States
Sanford Health Roger Maris Cancer Center ( Site 4158)
Fargo, North Dakota, United States
University of Cincinnati Medical Center ( Site 4136)
Cincinnati, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C (Site 4125)
Columbus, Ohio, United States
Sidney Kimmel Cancer Center - Jefferson Health ( Site 4157)
Philadelphia, Pennsylvania, United States
AHN West Penn Hospital-Gynecologic Oncology ( Site 4111)
Pittsburgh, Pennsylvania, United States
Asplundh Cancer Pavilion ( Site 4107)
Willow Grove, Pennsylvania, United States
Women & Infants Hospital ( Site 4138)
Providence, Rhode Island, United States
Sanford Cancer Center-Gynecologic Oncology ( Site 4121)
Sioux Falls, South Dakota, United States
The West Clinic, PLLC dba West Cancer Center ( Site 4102)
Germantown, Tennessee, United States
Houston Methodist Hospital-Obstetrics and Gynecology ( Site 4130)
Houston, Texas, United States
Texas Oncology - San Antonio ( Site 8005)
San Antonio, Texas, United States
Texas Oncology - Gulf Coast ( Site 8006)
The Woodlands, Texas, United States
Hospital Británico de Buenos Aires-Oncology ( Site 1002)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1008)
Buenos Aires, Buenos Aires F.D., Argentina
Instituto Alexander Fleming-Alexander Fleming ( Site 1007)
Buenos Aires, Buenos Aires F.D., Argentina
Hospital Aleman-Oncology ( Site 1001)
Buenos Aires, Argentina
Instituto de Oncología Angel H. Roffo ( Site 1003)
Buenos Aires, Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 1004)
Buenos Aires, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 1006)
La Rioja, Argentina
GenesisCare North Shore ( Site 1103)
St Leonards, New South Wales, Australia
Blacktown Hospital ( Site 1101)
Sydney, New South Wales, Australia
Royal Brisbane and Women's Hospital ( Site 1102)
Brisbane, Queensland, Australia
Epworth Freemasons ( Site 1104)
East Melbourne, Victoria, Australia
Frankston Hospital ( Site 1105)
Frankston, Victoria, Australia
Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 1201)
Innsbruck, Tyrol, Austria
Medizinische Universität Wien ( Site 1202)
Vienna, Austria
AZ Maria Middelares-IKG ( Site 1305)
Ghent, Oost-Vlaanderen, Belgium
UZ Gent-Medical oncology ( Site 1303)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven-Gynecologic Oncology ( Site 1301)
Leuven, Vlaams-Brabant, Belgium
AZ Delta vzw-Oncology ( Site 1302)
Roeselare, West-Vlaanderen, Belgium
CHU UCL Namur/Site Sainte Elisabeth-Trial Office ( Site 1304)
Namur, Belgium
Hospital São Domingos ( Site 1365)
São Luís, Maranhão, Brazil
Centro Oncologico do Triangulo ( Site 1360)
Uberlândia, Minas Gerais, Brazil
Hospital Moinhos de Vento ( Site 1359)
Porto Alegre, Rio Grande do Sul, Brazil
Instituto Joinvilense de Hematologia e Oncologia ( Site 1353)
Joinville, Santa Catarina, Brazil
Instituto de Ensino e Pesquisa ( Site 1355)
Sorocaba, São Paulo, Brazil
Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 1352)
Rio de Janeiro, Brazil
Hospital Samaritano De Sao Paulo ( Site 1367)
São Paulo, Brazil
A. C. Camargo Cancer Center ( Site 1351)
São Paulo, Brazil
IBCC - Núcleo de Pesquisa e Ensino ( Site 1366)
São Paulo, Brazil
Arthur J.E. Child Comprehensive Cancer Centre ( Site 1413)
Calgary, Alberta, Canada
Cross Cancer Institute ( Site 1414)
Edmonton, Alberta, Canada
BC Cancer Vancouver ( Site 1415)
Vancouver, British Columbia, Canada
Trillium Health Partners - Credit Valley Hospital ( Site 1410)
Mississauga, Ontario, Canada
CIUSSS- saguenay-Lac-Saint-Jean ( Site 1408)
Chicoutimi, Quebec, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 1405)
Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal ( Site 1403)
Montreal, Quebec, Canada
McGill University Health Centre ( Site 1404)
Montreal, Quebec, Canada
James Lind Centro de Investigacion del Cancer ( Site 1504)
Temuco, Araucania, Chile
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1505)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 1503)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 1501)
Santiago, Region M. de Santiago, Chile
Second Affiliated hospital of Anhui Medical University-Oncology ( Site 1635)
Hefei, Anhui, China
Beijing Obstetric and Gynecology Hospital ( Site 1653)
Beijing, Beijing Municipality, China
Fujian Cancer Hospital-Gynecological Oncology Surgery ( Site 1627)
Fuzhou, Fujian, China
The First Affiliated hospital of Xiamen University-Obstetrics and gynecology department ( Site 1613)
Xiamen, Fujian, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1634)
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center ( Site 1604)
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College ( Site 1642)
Shantou, Guangdong, China
Affiliated Hospital of Guangdong Medical University ( Site 1614)
Zhanjiang, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital-Gynecological oncology ( Site 1622)
Nanning, Guangxi, China
Hainan General Hospital ( Site 1636)
Haikou, Hainan, China
Harbin Medical University Cancer Hospital-Gynecological Radiotherapy Department ( Site 1652)
Harbin, Heilongjiang, China
Henan Cancer Hospital ( Site 1618)
Zhengzhou, Henan, China
The Second Affiliated Hospital of Zhengzhou University ( Site 1640)
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1621)
Wuhan, Hubei, China
Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 1607)
Wuhan, Hubei, China
Xiangya Hospital Central South University-Gynecology ( Site 1603)
Changsha, Hunan, China
Hunan Cancer Hospital ( Site 1623)
Changsha, Hunan, China