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)
Start Date
1/19/2026
Completion Date
10/29/2031
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
Detailed Description
This is a 2-part study. In Part 1 Safety Run-in, eligible participants will be allocated to treatment with sac-TMT + pembrolizumab + bevacizumab. In Part 2, all participants receive standard of care induction treatment. Eligible participants whose cancer does not progress then begin maintenance treatment and are randomized to receive pembrolizumab or sac-TMT + pembrolizumab. All participants in Part 2 maintenance treatment may also receive bevacizumab at the investigator's discretion.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Pembrolizumab
Sacituzumab Tirumotecan
Bevacizumab
Paclitaxel
Cisplatin
Carboplatin
Rescue Medications
Conditions
Locations
Florida Cancer Specialists - South ( Site 7001)
Fort Myers, Florida 33901
United States
Mount Sinai Comprehensive Cancer Center ( Site 5043)
Miami Beach, Florida 33140
United States
Mount Sinai Comprehensive Cancer Center ( Site 6000)
Miami Beach, Florida 33140
United States
Florida Cancer Specialists - East ( Site 7000)
West Palm Beach, Florida 33401
United States
Winship Cancer Institute of Emory University ( Site 5005)
Atlanta, Georgia 30308
United States
Nancy N. & J.C. Lewis Cancer and Research Pavillion - Research Department ( Site 6005)
Savannah, Georgia 31405
United States
TRIALS 365 ( Site 6008)
Shreveport, Louisiana 71103
United States
Minnesota Oncology Hematology, PA ( Site 8003)
Edina, Minnesota 55435
United States
Women's Cancer Center of Nevada ( Site 6011)
Las Vegas, Nevada 89106
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6009)
New York, New York 10016
United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6001)
Tulsa, Oklahoma 74146
United States
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)
Eugene, Oregon 97401
United States
Women & Infants Hospital ( Site 6003)
Providence, Rhode Island 02905
United States
University of Tennessee Medical Center ( Site 6012)
Knoxville, Tennessee 37920
United States
Texas Oncology - DFW ( Site 8005)
Fort Worth, Texas 76104
United States
Texas Oncology-The Woodlands ( Site 8000)
The Woodlands, Texas 77380
United States
Texas Oncology - Northeast Texas ( Site 8002)
Tyler, Texas 75702
United States
University of Virginia Cancer Center ( Site 5044)
Charlottesville, Virginia 22908
United States
University of Virginia Cancer Center ( Site 6014)
Charlottesville, Virginia 22908
United States
Centro de Oncología e Investigación de Buenos Aires ( Site 0107)
Berazategui, Buenos Aires B1884BBF
Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0105)
Mar del Plata, Buenos Aires B7600FZO
Argentina
Fundación Respirar ( Site 0101)
Belgrano, Buenos Aires F.D. C1118AAT
Argentina
Instituto Misionero del Cancer ( Site 0112)
Posadas, Misiones Province N3300KAZ
Argentina
Instituto de Oncologia de Rosario ( Site 0104)
Rosario, Santa Fe Province S2000KZE
Argentina
Hospital Provincial del Centenario ( Site 0106)
Rosario, Santa Fe Province S2002KDS
Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0111)
La Rioja, F5300COE
Argentina
Medizinische Universitaet Wien ( Site 0302)
Vienna, State of Vienna 1090
Austria
Medizinische Universitat Graz ( Site 0303)
Graz, Styria 8036
Austria
Medizinische Universitaet Innsbruck ( Site 0301)
Innsbruck, Tyrol 6020
Austria
Uniklinikum Salzburg Landeskrankenhaus ( Site 0304)
Salzburg, 5020
Austria
Antwerp University Hospital ( Site 0407)
Edegem, Antwerpen 2650
Belgium
Cliniques Universitaires Saint-Luc ( Site 0402)
Brussels, Bruxelles-Capitale, Region de 1200
Belgium
Grand Hopital de Charleroi ( Site 0404)
Charleroi, Hainaut 6060
Belgium
UZ Gent ( Site 0406)
Ghent, Oost-Vlaanderen 9000
Belgium
UZ Leuven ( Site 0401)
Leuven, Vlaams-Brabant 3000
Belgium
Hospital Araújo Jorge ( Site 0518)
Goiânia, Goiás 74605070
Brazil
Liga Norte Riograndense Contra o Câncer ( Site 0513)
Natal, Rio Grande do Norte 59062-000
Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0514)
Porto Alegre, Rio Grande do Sul 90020-090
Brazil
Hospital São Lucas da PUCRS ( Site 0516)
Porto Alegre, Rio Grande do Sul 90610-000
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0511)
Barretos, São Paulo 14784-400
Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0512)
São José do Rio Preto, São Paulo 15091-000
Brazil
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0517)
São Paulo, São Paulo 04014-002
Brazil
Instituto Nacional de Câncer - INCA ( Site 0515)
Rio de Janeiro, 20220-410
Brazil
London Health Sciences Centre ( Site 0613)
London, Ontario N6A 5W9
Canada
Sunnybrook Research Institute ( Site 0605)
Toronto, Ontario M4N 3M5
Canada
Princess Margaret Cancer Centre ( Site 0601)
Toronto, Ontario M5G 2M9
Canada
Centre Hospitalier de l'Université de Montréal ( Site 0616)
Montreal, Quebec H2X 0C1
Canada
McGill University Health Centre ( Site 0602)
Montreal, Quebec H4A 3J1
Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0611)
Québec, Quebec G1J 1Z4
Canada
CIUSSS de l Estrie Centre Hospitalier Universitaire de Sherbrooke ( Site 0604)
Sherbrooke, Quebec J1H 5N4
Canada
CIDO SpA-Oncology ( Site 0708)
Temuco, Araucania 4810148
Chile
IC La Serena Research ( Site 0710)
La Serena, Coquimbo Region 1720430
Chile
FALP ( Site 0701)
Santiago, Region M. de Santiago 7500921
Chile
Pontificia Universidad Catolica de Chile-CICUC ( Site 0706)
Santiago, Region M. de Santiago 8330073
Chile
Bradfordhill ( Site 0702)
Santiago, Region M. de Santiago 8420383
Chile
ONCOCENTRO APYS-ACEREY ( Site 0703)
Viña del Mar, Valparaiso 2520598
Chile
Clinica Somer ( Site 0903)
Rionegro, Antioquia 054040
Colombia
Centro Cancerológico del Caribe (CECAC) ( Site 0906)
Barranquilla, Atlántico 080002
Colombia
Instituto Nacional De Cancerologia ( Site 0909)
Bogotá, Bogota D.C. 111511
Colombia
Oncomédica S.A.S ( Site 0905)
Montería, Departamento de Córdoba 230002
Colombia
Oncólogos del Occidente S.A.S. ( Site 0908)
Pereira, Risaralda Department 660001
Colombia
Fakultní Nemocnice Brno ( Site 1003)
Brno, Brno-mesto 602 00
Czechia
Nemocnice AGEL Novy Jicin a.s. ( Site 1004)
Nový Jičín, Moravian-Silesian Region 741 01
Czechia
Fakultni nemocnice Ostrava ( Site 1005)
Ostrava, Moravian-Silesian Region 708 52
Czechia
Fakultni nemocnice Kralovske Vinohrady ( Site 1002)
Prague, Praha 10 100 34
Czechia
Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 1001)
Prague, 128 08
Czechia
CHU Strasbourg-Hautepierre ( Site 1207)
Strasbourg, Alsace 67098
France
CHRU de Brest-Institut de cancérologie et d'Hématologie ( Site 1202)
Brest, Brittany Region 29609
France
Centre François Baclesse ( Site 1201)
Caen, Calvados 14076
France
Pôle Santé Léonard de Vinci ( Site 1209)
Chambray-lès-Tours, Centre-Val de Loire 37170
France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1204)
Bordeaux, Gironde 33076
France
LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1203)
Toulouse, Haute-Garonne 31059
France
Hopital Europeen Georges Pompidou ( Site 1210)
Paris, 75015
France
Universitaetsklinikum Jena ( Site 1303)
Jena, Thuringia 07747
Germany
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 1401)
Athens, Attica 115 28
Greece
Aretaieio Hospital Oncology Unit ( Site 1402)
Athens, Attica 115 28
Greece
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1403)
Chaïdári, Attica 124 62
Greece
Országos Onkológiai Intézet ( Site 1603)
Budapest, 1122
Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 1601)
Debrecen, 4032
Hungary
Mahatma Gandhi Cancer Hospital and Research Institute ( Site 1714)
Visakhapatnam, Andhra Pradesh 530017
India
KLES Prabhakar Kore Hospital & Medical Research Centre [M] ( Site 1705)
Belagavi, Karnataka 590010
India
Mater Misercordiae University Hospital ( Site 1804)
Dublin, D07 R2WY
Ireland
St Jame's Hospital ( Site 1801)
Dublin, D08 NHY1
Ireland
Hillel Yaffe Medical Center ( Site 1903)
Hadera, 0038100
Israel
Rambam Health Care Campus ( Site 1907)
Haifa, 3109601
Israel
Carmel Hospital ( Site 1901)
Haifa, 3436212
Israel
Shaare Zedek Medical Center ( Site 1905)
Jerusalem, 9103102
Israel
Rabin Medical Center ( Site 1904)
Petah Tikva, 4941492
Israel
Sourasky Medical Center ( Site 1902)
Tel Aviv, 6423906
Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 2009)
Meldola, Forli-Cesena 47014
Italy
CRO-IRCCS ( Site 2014)
Aviano, Friuli Venezia Giulia 33081
Italy
Ospedale Humanitas San Pio X ( Site 2013)
Milan, Lombardy 20159
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 2008)
Milan, Milano 20133
Italy
ASST Spedali Civili ( Site 2001)
Brescia, 25123
Italy
Ospedale Cannizzaro ( Site 2010)
Catania, 95126
Italy
Istituto Europeo di Oncologia ( Site 2003)
Milan, 20141
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2012)
Roma, 00168
Italy
Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 2006)
Torino, 10128
Italy
AULSS 2 MARCA TREVIGIANA ( Site 2011)
Treviso, 95123
Italy
Aichi Cancer Center ( Site 2114)
Nagoya, Aichi-ken 464-8681
Japan
Kurume University Hospital ( Site 2112)
Kurume, Fukuoka 830-0011
Japan
Gunma Prefectural Cancer Center ( Site 2109)
Ōta, Gunma 373-8550
Japan
National Hospital Organization Hokkaido Cancer Center ( Site 2108)
Sapporo, Hokkaido 003-0804
Japan
Hyogo Cancer Center ( Site 2118)
Akashi, Hyōgo 673-8558
Japan
Iwate Medical University Hospital ( Site 2116)
Shiwa-gun, Iwate 028-3695
Japan
Kanagawa Cancer Center ( Site 2121)
Yokohama, Kanagawa 241-8515
Japan
University of the Ryukyus Hospital ( Site 2117)
Ginowan, Okinawa 901-2725
Japan
Saitama Medical University International Medical Center ( Site 2106)
Hidaka, Saitama 350-1298
Japan
Shizuoka Cancer Center ( Site 2104)
Sunto-gun,, Shizuoka 411-8777
Japan
Cancer Institute Hospital of JFCR ( Site 2119)
Koto, Tokyo 135-8550
Japan
The Jikei University Hospital ( Site 2107)
Minato, Tokyo 105-8471
Japan
Keio University Hospital ( Site 2103)
Shinjyuku, Tokyo 160-8582
Japan
National Hospital Organization Kyushu Cancer Center ( Site 2102)
Fukuoka, 811-1395
Japan
Niigata Cancer Center Hospital ( Site 2110)
Niigata, 951-8566
Japan
Okayama University Hospital ( Site 2101)
Okayama, 700-8558
Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2111)
Osaka, 541-8567
Japan
CANCER TREAMTENT CLINIC AND CLINICAL TRIALS SA DE CV ( Site 2204)
Guadalajara, Jalisco 44260
Mexico
Grupo Médico ASSET ( Site 2203)
Mexico City, Mexico City 03100
Mexico
Higiea Oncologia ( Site 2205)
Mexico City, Mexico City 11819
Mexico
Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 2202)
Monterrey, Nuevo León 64460
Mexico
Scientia Investigacion Clinica S.C. ( Site 2201)
Chihuahua City, 31207
Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 2207)
Oaxaca City, 68020
Mexico
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2605)
Warsaw, Masovian Voivodeship 02-781
Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 2604)
Gliwice, Silesian Voivodeship 44-102
Poland
Mazowiecki Szpital Wojewódzki w Siedlcach ( Site 2601)
Siedlce, Warmian-Masurian Voivodeship 08-110
Poland
Swietokrzyskie Centrum Onkologii. ( Site 2602)
Kielce, Świętokrzyskie Voivodeship 25-734
Poland
Univ. Pretoria and Steve Biko Academic Hospitals ( Site 2804)
Pretoria, Gauteng 0002
South Africa
Curo Oncology. ( Site 2811)
Pretoria, Gauteng 0084
South Africa
Wits Clinical Research ( Site 2813)
Soweto, Gauteng 2113
South Africa
Hopelands Cancer Centre ( Site 2816)
Hilton, KwaZulu-Natal 3245
South Africa
National Cancer Center ( Site 2905)
Goyang-si, Kyonggi-do 10408
South Korea
Seoul National University Hospital ( Site 2901)
Jongno-gu, Seoul 03080
South Korea
Severance Hospital Yonsei University Health System ( Site 2902)
Seodaemun-Gu, Seoul 03722
South Korea
Asan Medical Center ( Site 2904)
Seoul, 05505
South Korea
Samsung Medical Center ( Site 2903)
Seoul, 06351
South Korea
Institut Català d'Oncologia (ICO) - Girona ( Site 3002)
Girona, Gerona 17007
Spain
Hosp Clinico Universitario de Valencia ( Site 3001)
Valencia, Valenciana, Comunitat 46010
Spain
Hospital Universitari Vall d Hebron ( Site 3003)
Barcelona, 08035
Spain
Hospital Universitario Reina Sofia ( Site 3006)
Córdoba, 14004
Spain
Hospital Ramon y Cajal ( Site 3005)
Madrid, 28034
Spain
Hospital Universitario 12 de Octubre ( Site 3007)
Madrid, 28041
Spain
Hospital Universitario La Paz ( Site 3004)
Madrid, 28046
Spain
Skanes Universitetssjukhus Lund ( Site 3103)
Lund, Skåne County 22242
Sweden
Karolinska Universitetssjukhuset-Solna ( Site 3102)
Stockholm, Stockholm County 171 64
Sweden
Linköping University Hospital ( Site 3101)
Linköping, Östergötland County 581 85
Sweden
National Taiwan University Hospital ( Site 3301)
Taiwan, Taipei 10002
Taiwan
Taichung Veterans General Hospital ( Site 3304)
Taichung, 40705
Taiwan
National Cheng Kung University Hospital ( Site 3308)
Tainan, 704
Taiwan
Mackay Memorial Hospital ( Site 3303)
Taipei, 10449
Taiwan
Chang Gung Memorial Hospital ( Site 3302)
Taoyuan, 333
Taiwan
Chulalongkorn University ( Site 3403)
Bangkok, Bangkok 10330
Thailand
Ramathibodi Hospital ( Site 3404)
Bangkok, Bangkok 10400
Thailand
Faculty of Medicine Siriraj Hospital ( Site 3401)
Bangkok, Bangkok 10700
Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 3402)
Chiang Mai, 50200
Thailand
The Christie Hospital NHS Foundation Trust ( Site 3602)
Withington, Manchester M20 4BX
United Kingdom