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)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Pembrolizumab
  • Sacituzumab Tirumotecan
  • Bevacizumab
  • Paclitaxel
  • Cisplatin
  • Carboplatin
  • Rescue Medications

Treatment groups

1,023 Participants
are divided into 3 treatment groups

Locations

138
Argentina
Centro de Oncología e Investigación de Buenos Aires ( Site 0107)B1884BBF, BerazateguiBuenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0105)B7600FZO, Mar del PlataBuenos Aires, Argentina
Fundación Respirar ( Site 0101)C1118AAT, BelgranoBuenos Aires F.D., Argentina
Instituto Misionero del Cancer ( Site 0112)N3300KAZ, PosadasMisiones Province, Argentina

Sponsors and collaborators

Merck Sharp & Dohme LLC

Lead sponsor

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Collaborator

GOG Foundation

Collaborator