Status:
RECRUITING
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
This is a 2-part study. In Part 1 Safety Run-in, eligible participants will be allocated to treatment with sac-TMT + pembrolizumab + bevacizumab. In Part 2, all participants receive standard of care...
Eligibility Criteria
Inclusion
- 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 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 (e.g., 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 (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has a history of stem cell/solid organ transplant
- Has not adequately recovered from major surgery or has ongoing surgical complications
Exclusion
Key Trial Info
Start Date :
December 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 29 2031
Estimated Enrollment :
1023 Patients enrolled
Trial Details
Trial ID
NCT07216703
Start Date
December 12 2025
End Date
October 29 2031
Last Update
December 2 2025
Active Locations (1)
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1
TRIALS 365 ( Site 6008)
Shreveport, Louisiana, United States, 71103