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RECRUITING

NCT07216703

PHASE3

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

View on ClinicalTrials.gov

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

Official title: 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)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1023

Start Date

2026-01-19

Completion Date

2031-10-29

Last Updated

2026-04-09

Healthy Volunteers

Conditions

Cervical Cancer

Interventions

BIOLOGICAL

Pembrolizumab

Intravenous (IV) Infusion

BIOLOGICAL

Sacituzumab Tirumotecan

IV Infusion

BIOLOGICAL

Bevacizumab

IV Infusion

DRUG

Paclitaxel

IV Infusion

DRUG

Cisplatin

IV Infusion

DRUG

Carboplatin

IV Infusion

DRUG

Rescue 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).

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

Locations (81)

Mount Sinai Comprehensive Cancer Center ( Site 6000)

Miami 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 - Northeast Texas ( Site 8002)

Tyler, Texas, 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

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, Moravskoslezský kraj, Czechia

Fakultni nemocnice Ostrava ( Site 1005)

Ostrava, Moravskoslezský kraj, 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

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

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 District, Taiwan

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (81)