RecruitingPhase 3NCT07216703

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)

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)


Sponsor

Merck Sharp & Dohme LLC

Enrollment

1,023 participants

Start Date

Jan 19, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — sacituzumab tirumotecan and pembrolizumab (an immunotherapy) — as a maintenance treatment for people with advanced or metastatic cervical cancer that cannot be cured with surgery or radiation. **You may be eligible if...** - You have been diagnosed with cervical cancer (squamous cell, adenosquamous, or adenocarcinoma type) that has spread or come back - Your cancer cannot be treated with surgery or radiation - Your cancer has a protein called PD-L1 with a score of 1 or higher - You are generally able to care for yourself (functioning well day-to-day) - If you have HIV, it is well-controlled with medication **You may NOT be eligible if...** - You have active inflammatory bowel disease (like Crohn's disease or ulcerative colitis) - You have serious heart or blood vessel disease that is not controlled - You have a history of severe dry eye, corneal disease, or lung disease requiring steroids - You have received prior chemotherapy or systemic cancer treatment - You have an autoimmune disease requiring treatment in the past 2 years - You have had a stem cell or organ transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPembrolizumab

Intravenous (IV) Infusion

BIOLOGICALSacituzumab Tirumotecan

IV Infusion

BIOLOGICALBevacizumab

IV Infusion

DRUGPaclitaxel

IV Infusion

DRUGCisplatin

IV Infusion

DRUGCarboplatin

IV Infusion

DRUGRescue 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(87)

Mount Sinai Comprehensive Cancer Center ( Site 6000)

Miami Beach, Florida, United States

Florida Cancer Specialists - East ( Site 7000)

West Palm Beach, Florida, United States

TRIALS 365 ( Site 6008)

Shreveport, Louisiana, United States

Women's Cancer Center of Nevada ( Site 6011)

Las Vegas, Nevada, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6009)

New York, New York, United States

Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)

Eugene, Oregon, United States

University of Tennessee Medical Center ( Site 6012)

Knoxville, Tennessee, United States

Texas Oncology - DFW ( Site 8005)

Fort Worth, 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 6014)

Charlottesville, Virginia, United States

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 de Oncologia de Rosario ( Site 0104)

Rosario, Santa Fe Province, Argentina

Hospital Provincial del Centenario ( Site 0106)

Rosario, Santa Fe Province, Argentina

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0111)

La Rioja, Argentina

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

UZ Gent ( Site 0406)

Ghent, Oost-Vlaanderen, Belgium

UZ Leuven ( Site 0401)

Leuven, Vlaams-Brabant, Belgium

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

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

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

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

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

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

Ospedale Humanitas San Pio X ( Site 2013)

Milan, Lombardy, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 2008)

Milan, Milano, Italy

Ospedale Cannizzaro ( Site 2010)

Catania, Italy

Istituto Europeo di Oncologia ( Site 2003)

Milan, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2012)

Roma, Italy

Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 2006)

Torino, Italy

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

University of the Ryukyus Hospital ( Site 2117)

Ginowan, Okinawa, Japan

Saitama Medical University International Medical Center ( Site 2106)

Hidaka, Saitama, Japan

Cancer Institute Hospital of JFCR ( Site 2119)

Koto, Tokyo, Japan

Niigata Cancer Center Hospital ( Site 2110)

Niigata, Japan

Okayama University Hospital ( Site 2101)

Okayama, Japan

Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 2604)

Gliwice, Silesian Voivodeship, Poland

Mazowiecki Szpital Wojewódzki w Siedlcach ( Site 2601)

Siedlce, Warmian-Masurian Voivodeship, Poland

Swietokrzyskie Centrum Onkologii. ( Site 2602)

Kielce, Świętokrzyskie Voivodeship, Poland

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

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

View Full Details on ClinicalTrials.gov

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NCT07216703


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