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NCT07216703PHASE3Recruiting

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)

Merck Sharp & Dohme LLC

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

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

Interventions

BIOLOGICAL

Pembrolizumab

BIOLOGICAL

Sacituzumab Tirumotecan

BIOLOGICAL

Bevacizumab

DRUG

Paclitaxel

DRUG

Cisplatin

DRUG

Carboplatin

DRUG

Rescue Medications

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Conditions

Cervical Cancer

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