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)
- Cervical Cancer
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Merck Sharp & Dohme LLC
- Enrolment target
- 1,023
- Started
- 19 January 2026
- Main results due
- 29 October 2031
- Study sites
- 177
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Women only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
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
Study sites(177)
University of Alabama- Birmingham ( Site 5015)
Birmingham, Alabama, United States
Recruiting
CHAO Family Comprehensive Cancer Center and Ambulatory Care ( Site 5037)
Irvine, California, United States
Recruiting
University of California Irvine Medical Center ( Site 6006)
Orange, California, United States
Recruiting
Florida Cancer Specialists - South ( Site 7001)
Fort Myers, Florida, United States
Recruiting
Mount Sinai Braman Comprehensive Cancer Center ( Site 5043)
Miami Beach, Florida, United States
Recruiting
Mount Sinai Comprehensive Cancer Center ( Site 6000)
Miami Beach, Florida, United States
Recruiting
Florida Cancer Specialists - East ( Site 7000)
West Palm Beach, Florida, United States
Recruiting
Winship Cancer Institute of Emory University ( Site 5005)
Atlanta, Georgia, United States
Recruiting
Nancy N. & J.C. Lewis Cancer and Research Pavillion - Research Department ( Site 6005)
Savannah, Georgia, United States
Recruiting
TRIALS 365 ( Site 6008)
Shreveport, Louisiana, United States
Recruiting
Maryland Oncology Hematology (MOH) ( Site 8001)
Columbia, Maryland, United States
Recruiting
Minnesota Oncology Hematology, PA ( Site 8003)
Edina, Minnesota, United States
Recruiting
Women's Cancer Center of Nevada ( Site 6011)
Las Vegas, Nevada, United States
Recruiting
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 5039)
Mineola, New York, United States
Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6009)
New York, New York, United States
Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6002)
Columbus, Ohio, United States
Recruiting
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6001)
Tulsa, Oklahoma, United States
Recruiting
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)
Eugene, Oregon, United States
Recruiting
Honickman Center ( Site 5033)
Philadelphia, Pennsylvania, United States
Recruiting
Asplundh Cancer Pavilion ( Site 5002)
Willow Grove, Pennsylvania, United States
Recruiting
Women & Infants Hospital ( Site 6003)
Providence, Rhode Island, United States
Recruiting
University of Tennessee Medical Center ( Site 6012)
Knoxville, Tennessee, United States
Recruiting
Texas Oncology - DFW ( Site 8005)
Fort Worth, Texas, United States
Recruiting
Houston Methodist Hospital-Obstetrics and Gynecology ( Site 6010)
Houston, Texas, United States
Recruiting
Texas Oncology-The Woodlands ( Site 8000)
The Woodlands, Texas, United States
Recruiting
Texas Oncology - Northeast Texas ( Site 8002)
Tyler, Texas, United States
Recruiting
University of Virginia Cancer Center ( Site 5044)
Charlottesville, Virginia, United States
Recruiting
University of Virginia Cancer Center ( Site 6014)
Charlottesville, Virginia, United States
Recruiting
Inova Schar Cancer Institute ( Site 5045)
Fairfax, Virginia, United States
Recruiting
Centro de Oncología e Investigación de Buenos Aires ( Site 0107)
Berazategui, Buenos Aires, Argentina
Recruiting
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0105)
Mar del Plata, Buenos Aires, Argentina
Recruiting
Fundación Respirar ( Site 0101)
Belgrano, Buenos Aires F.D., Argentina
Recruiting
Instituto Misionero del Cancer ( Site 0112)
Posadas, Misiones Province, Argentina
Recruiting
Instituto de Oncologia de Rosario ( Site 0104)
Rosario, Santa Fe Province, Argentina
Recruiting
Hospital Provincial del Centenario ( Site 0106)
Rosario, Santa Fe Province, Argentina
Recruiting
Centro Medico Privado CEMAIC ( Site 0102)
Córdoba, Argentina
Recruiting
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0111)
La Rioja, Argentina
Recruiting
Medizinische Universitaet Wien ( Site 0302)
Vienna, State of Vienna, Austria
Recruiting
Medizinische Universitat Graz ( Site 0303)
Graz, Styria, Austria
Recruiting
Medizinische Universitaet Innsbruck ( Site 0301)
Innsbruck, Tyrol, Austria
Recruiting
Uniklinikum Salzburg Landeskrankenhaus ( Site 0304)
Salzburg, Austria
Recruiting
Antwerp University Hospital ( Site 0407)
Edegem, Antwerpen, Belgium
Recruiting
Cliniques Universitaires Saint-Luc ( Site 0402)
Brussels, Bruxelles-Capitale, Region de, Belgium
Recruiting
Grand Hopital de Charleroi ( Site 0404)
Charleroi, Hainaut, Belgium
Recruiting
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0403)
Liège, Liege, Belgium
Recruiting
UZ Gent ( Site 0406)
Ghent, Oost-Vlaanderen, Belgium
Recruiting
UZ Leuven ( Site 0401)
Leuven, Vlaams-Brabant, Belgium
Recruiting
Hospital Araújo Jorge ( Site 0518)
Goiânia, Goiás, Brazil
Recruiting
Liga Norte Riograndense Contra o Câncer ( Site 0513)
Natal, Rio Grande do Norte, Brazil
Recruiting
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0514)
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
Hospital São Lucas da PUCRS ( Site 0516)
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0511)
Barretos, São Paulo, Brazil
Recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0512)
São José do Rio Preto, São Paulo, Brazil
Recruiting
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0517)
São Paulo, São Paulo, Brazil
Recruiting
Instituto Nacional de Câncer - INCA ( Site 0515)
Rio de Janeiro, Brazil
Recruiting
Nova Scotia Cancer Centre ( Site 0617)
Halifax, Nova Scotia, Canada
Recruiting
London Health Sciences Centre ( Site 0613)
London, Ontario, Canada
Recruiting
Sunnybrook Research Institute ( Site 0605)
Toronto, Ontario, Canada
Recruiting
Princess Margaret Cancer Centre ( Site 0601)
Toronto, Ontario, Canada
Recruiting
Centre Hospitalier de l'Université de Montréal ( Site 0616)
Montreal, Quebec, Canada
Recruiting
Showing 60 of 177 sites — filter to narrow it down. 177 of the 177 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07216703. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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