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RECRUITING Phase 3 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07216703

Registry updated: 2026-10-13
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Description

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

Interventions

  • Pembrolizumab (Biological)
    Intravenous (IV) Infusion
  • Sacituzumab Tirumotecan (Biological)
    IV Infusion
  • Bevacizumab (Biological)
    IV Infusion
  • Paclitaxel (Drug)
    IV Infusion
  • Cisplatin (Drug)
    IV Infusion
  • Carboplatin (Drug)
    IV Infusion
  • Rescue Medications (Drug)
    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).

Eligibility criteria

The main inclusion criteria include but are not limited to the following: * Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix * Has persistent, recurrent, or newly diagnosed metastatic (International Federation of Gynecology and Obstetrics \[FIGO\]-2028 Stage IVB) cervical cancer that is not amenable to curative treatment (surgery and/or radiation) * If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy * If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load * If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load * Has an Eastern Cooperative Oncology Group performance status of 0 or 1 * Has tumor programmed cell death ligand 1 expression of combined positive score ≥1 The main exclusion criteria include but are not limited to the following: * Has HIV infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has a 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 * Has received prior systemic anticancer therapy other than what is specified in this protocol * Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sac-TMT * Has a diagnosis of immunodeficiency * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years * Has known active central nervous system metastases and/or carcinomatous meningitis * Has active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed * Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments * Has a history of stem cell/solid organ transplant * Has not adequately recovered from major surgery or has ongoing surgical complications

Conditions

Cervical Cancer

Locations

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • CHU Strasbourg-Hautepierre ( Site 1207) — Strasbourg, Alsace, 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
  • Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 1401) — Athens, Attica, Greece
  • Aretaieio Hospital Oncology Unit ( Site 1402) — Athens, Attica, Greece
  • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1403) — Chaïdári, Attica, Greece
  • Országos Onkológiai Intézet ( Site 1603) — Budapest, Hungary
  • Debreceni Egyetem Klinikai Kozpont ( Site 1601) — Debrecen, Hungary
  • Mahatma Gandhi Cancer Hospital and Research Institute ( Site 1714) — Visakhapatnam, Andhra Pradesh, India
  • KLES Prabhakar Kore Hospital & Medical Research Centre [M] ( Site 1705) — Belagavi, Karnataka, India
  • Cork University Hospital ( Site 1802) — Cork, Ireland
  • Mater Misercordiae University Hospital ( Site 1804) — Dublin, Ireland
  • St Jame's Hospital ( Site 1801) — Dublin, Ireland
  • Hillel Yaffe Medical Center ( Site 1903) — Hadera, Israel
  • Rambam Health Care Campus ( Site 1907) — Haifa, Israel
  • Carmel Hospital ( Site 1901) — Haifa, Israel
  • Shaare Zedek Medical Center ( Site 1905) — Jerusalem, Israel
  • Rabin Medical Center ( Site 1904) — Petah Tikva, Israel
  • Sourasky Medical Center ( Site 1902) — Tel Aviv, Israel
  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 2009) — Meldola, Forli-Cesena, Italy
  • CRO-IRCCS ( Site 2014) — Aviano, Friuli Venezia Giulia, Italy
  • Ospedale Humanitas San Pio X ( Site 2013) — Milan, Lombardy, Italy
  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 2008) — Milan, Milano, Italy
  • ASST Spedali Civili ( Site 2001) — Brescia, Italy
  • Ospedale Cannizzaro ( Site 2010) — Catania, Italy
  • Istituto Europeo di Oncologia ( Site 2003) — Milan, Italy
  • Istituto Oncologico Veneto IRCCS ( Site 2005) — Padova, Italy
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2012) — Roma, Italy
  • Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 2006) — Torino, Italy
  • AULSS 2 MARCA TREVIGIANA ( Site 2011) — Treviso, Italy
  • Aichi Cancer Center ( Site 2114) — Nagoya, Aichi-ken, Japan
  • Ehime University Hospital ( Site 2105) — Tōon, Ehime, Japan
  • Kurume University Hospital ( Site 2112) — Kurume, Fukuoka, Japan
  • Gunma Prefectural Cancer Center ( Site 2109) — Ōta, Gunma, Japan
  • National Hospital Organization Hokkaido Cancer Center ( Site 2108) — Sapporo, Hokkaido, Japan
  • Hyogo Cancer Center ( Site 2118) — Akashi, Hyōgo, Japan
  • Iwate Medical University Hospital ( Site 2116) — Shiwa-gun, Iwate, Japan
  • Kanagawa Cancer Center ( Site 2121) — Yokohama, Kanagawa, Japan
  • University of the Ryukyus Hospital ( Site 2117) — Ginowan, Okinawa, Japan
  • Saitama Medical University International Medical Center ( Site 2106) — Hidaka, Saitama, Japan
  • Shizuoka Cancer Center ( Site 2104) — Sunto-gun,, Shizuoka, Japan
  • Cancer Institute Hospital of JFCR ( Site 2119) — Koto, Tokyo, Japan
  • The Jikei University Hospital ( Site 2107) — Minato, Tokyo, Japan
  • Keio University Hospital ( Site 2103) — Shinjyuku, Tokyo, Japan
  • National Hospital Organization Kyushu Cancer Center ( Site 2102) — Fukuoka, Japan
  • Niigata Cancer Center Hospital ( Site 2110) — Niigata, Japan
  • Okayama University Hospital ( Site 2101) — Okayama, Japan
  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2111) — Osaka, Japan
  • CANCER TREAMTENT CLINIC AND CLINICAL TRIALS SA DE CV ( Site 2204) — Guadalajara, Jalisco, Mexico
  • Grupo Médico ASSET SC ( Site 2203) — Benito Juárez, Mexico City, Mexico
  • Higiea Oncologia ( Site 2205) — Mexico City, Mexico City, Mexico
  • Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 2202) — Monterrey, Nuevo León, Mexico
  • Scientia Investigacion Clinica S.C. ( Site 2201) — Chihuahua City, Mexico
  • Centro de Investigacion Clinica de Oaxaca ( Site 2207) — Oaxaca City, Mexico
  • Perpetual Succour Hospital ( Site 2502) — Cebu City, Cebu, Philippines
  • Makati Medical Center ( Site 2503) — Makati City, National Capital Region, Philippines
  • Manila Doctors Hospital ( Site 2501) — Manila, National Capital Region, Philippines
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2605) — Warsaw, Masovian Voivodeship, Poland
  • Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 2604) — Gliwice, Silesian Voivodeship, Poland
  • Mazowiecki Szpital Wojewodzki w Siedlcach ( Site 2601) — Siedlce, Warmian-Masurian Voivodeship, Poland
  • Swietokrzyskie Centrum Onkologii. ( Site 2602) — Kielce, Świętokrzyskie Voivodeship, Poland
  • Wits Clinical Research ( Site 2803) — Johannesburg, Gauteng, South Africa
  • Univ. Pretoria and Steve Biko Academic Hospitals ( Site 2804) — Pretoria, Gauteng, South Africa
  • Curo Oncology. ( Site 2811) — Pretoria, Gauteng, South Africa
  • Wits Clinical Research ( Site 2813) — Soweto, Gauteng, South Africa
  • Hopelands Cancer Centre ( Site 2816) — Hilton, KwaZulu-Natal, South Africa
  • Groote Schuur Hospital ( Site 2805) — Cape Town, Western Cape, South Africa
  • National Cancer Center ( Site 2905) — Goyang-si, Kyonggi-do, South Korea
  • Seoul National University Hospital ( Site 2901) — Jongno-gu, Seoul, South Korea
  • Severance Hospital Yonsei University Health System ( Site 2902) — Seodaemun-Gu, Seoul, South Korea
  • Asan Medical Center ( Site 2904) — Seoul, South Korea
  • Samsung Medical Center ( Site 2903) — Seoul, South Korea
  • Institut Català d'Oncologia (ICO) - Girona ( Site 3002) — Girona, Gerona, Spain
  • Hosp Clinico Universitario de Valencia ( Site 3001) — Valencia, Valenciana, Comunitat, Spain
  • Hospital Universitari Vall d Hebron ( Site 3003) — Barcelona, Spain
  • Hospital Universitario Reina Sofia ( Site 3006) — Córdoba, Spain
  • Hospital Ramon y Cajal ( Site 3005) — Madrid, Spain
  • Hospital Universitario 12 de Octubre ( Site 3007) — Madrid, Spain
  • Hospital Universitario La Paz ( Site 3004) — Madrid, Spain
  • Skanes Universitetssjukhus Lund ( Site 3103) — Lund, Skåne County, Sweden
  • Karolinska Universitetssjukhuset-Solna ( Site 3102) — Stockholm, Stockholm County, Sweden
  • Linköping University Hospital ( Site 3101) — Linköping, Östergötland County, Sweden
  • National Taiwan University Hospital ( Site 3301) — Taiwan, Taipei, Taiwan
  • Taichung Veterans General Hospital ( Site 3304) — Taichung, Taiwan
  • National Cheng Kung University Hospital ( Site 3308) — Tainan, Taiwan
  • Mackay Memorial Hospital ( Site 3303) — Taipei, Taiwan
  • Chang Gung Memorial Hospital ( Site 3302) — Taoyuan, Taiwan
  • Chulalongkorn University ( Site 3403) — Bangkok, Bangkok, Thailand
  • Ramathibodi Hospital ( Site 3404) — Bangkok, Bangkok, Thailand
  • Faculty of Medicine Siriraj Hospital ( Site 3401) — Bangkok, Bangkok, Thailand
  • Maharaj Nakorn Chiang Mai Hospital ( Site 3402) — Chiang Mai, Thailand
  • Western General Hospital ( Site 3604) — Edinburgh, Edinburgh, City of, United Kingdom
  • The Royal Cornwall Hospital ( Site 3606) — Truro, England, United Kingdom
  • University College Hospital London ( Site 3605) — London, London, City of, United Kingdom
  • The Christie Hospital NHS Foundation Trust ( Site 3602) — Withington, Manchester, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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