Study

Overview

Official Title: 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

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

1023

Study Start Date:

January 2026

Estimated Study Completion Date:

October 2031

Estimated Primary Completion Date:

October 2031

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

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 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

Locations

United States Toll Free Number 1-800-770-4674

Miami Beach, Florida, 33140
Shreveport, Louisiana, 71103
Las Vegas, Nevada, 89106
New York, New York, 10016
Knoxville, Tennessee, 37920

Canada Study Coordinator 514-934-1934x31975

Results

No Study Results Posted

Study Detail

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)

Overview

Eligibility

CRITERIA

Locations

Results