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
Locations
138Sponsors and collaborators
Merck Sharp & Dohme LLC
Lead sponsor
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborator
GOG Foundation
Collaborator