Tests sacituzumab tirumotecan with pembrolizumab for metastatic cervical cancer
Tests sacituzumab tirumotecan with pembrolizumab, with or without bevacizumab, in adults with cervical cancer.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Barretos, Goiânia, Natal, Porto Alegre, Rio de Janeiro, São José do Rio Preto, and São Paulo, BrazilSee the 8 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with cervical cancer that has come back, not gone away, or is newly found and has spread. The tumour must show PD-L1 CPS of 1 or more.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix that is persistent, recurrent, or newly diagnosed and spread (FIGO-2018 Stage IVB), and cannot be treated with surgery or radiation meant to remove all of the disease. Performance status 0 or 1.
- Earlier treatment
- People who had other systemic cancer treatment not allowed by the protocol cannot join.
- Biomarker or test result
- Tumour PD-L1 expression with a combined positive score of 1 or more. If HIV-positive, HIV must be well controlled on antiretroviral therapy. If hepatitis B or C, viral load must be undetectable.
Main reasons for not taking part
- HIV with a history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Severe dry eye, severe eyelid gland disease or severe corneal disease
- Inflammatory bowel disease, or a history of it
- Immunodeficiency, or active autoimmune disease treated in the past 2 years
- History of stem cell or solid organ transplant
Read by machine on 9 November 2026.
Where in Brazil
- Fundação Pio XII - Hospital de Câncer de Barretos (Site 0511)Barretos, BrazilTaking people
- Hospital Araújo Jorge (Site 0518)Goiânia, BrazilTaking people
- Liga Norte Riograndense Contra o Câncer (Site 0513)Natal, BrazilTaking people
- Hospital São Lucas da PUCRS (Site 0516)Porto Alegre, BrazilTaking people
- Irmandade da Santa Casa de Misericordia de Porto Alegre (Site 0514)Porto Alegre, BrazilTaking people
- Instituto Nacional de Câncer - INCA (Site 0515)Rio de Janeiro, BrazilTaking people
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto (Site 0512)São José do Rio Preto, BrazilTaking people
- IBCC - Instituto Brasileiro de Controle do Câncer (Site 0517)São Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT07216703EU 2025-521514-26-00
- Record updated
- 6 November 2026
- Original 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.Read full original descriptionShow less
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)
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
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]-2018 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.