Back to search results

A Study of Sacituzumab Tirumotecan and Pembrolizumab for Cervical Cancer

This study is looking for new ways to treat metastatic cervical cancer, which is cancer that has spread from the cervix to other parts of the body. Researchers are studying sacituzumab tirumotecan (sac-TMT), an antibody drug conjugate that targets and destroys cancer cells, in combination with pembrolizumab and bevacizumab. The main goals are to understand the safety of these combinations and if they help people live longer without their cancer getting worse. You may be able to join if you are an adult woman with a confirmed diagnosis of certain types of metastatic cervical cancer that cannot be cured with other treatments. The study plans to enroll 1023 participants, but its current status is unclear.

Study design
This is a two-part interventional study. In Part 1, participants receive sac-TMT, pembrolizumab, and bevacizumab. In Part 2, after initial standard treatment, participants whose cancer has not progressed are randomly assigned to receive either pembrolizumab alone or sac-TMT plus pembrolizumab, with or without bevacizumab.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured for up to approximately 69 months, and progression-free survival will be measured for up to approximately 48 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07216703

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)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~1,023 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:PembrolizumabSacituzumab TirumotecanBevacizumabPaclitaxelCisplatinCarboplatin

At a glance

Recruiting sites
166 of 166 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs)
Measured over Up to approximately 69 months
+3 more outcomes measured

Conditions

Cervical Cancer

Explore related trials

Cervical CarcinomaProgrammed Cell Death 1 Ligand 1

Where it's being run

166 sites across 107 states
Italy7
Israel6
Spain5
Florida4
Texas4
Quebec4
Japan4
Gauteng4

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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
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

Exclusion

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

What this trial measures

  • Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs)Up to approximately 69 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  • Part 1 Safety Run-in: Number of Participants Who Discontinue Study Treatment Due to an AEUp to approximately 66 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  • Part 2 Maintenance Treatment: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)Up to approximately 48 months

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first, as assessed by RECIST 1.1 as evaluated by BICR. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.

  • Part 2 Maintenance Treatment: Overall Survival (OS)Up to approximately 60 months

    OS is defined as time from randomization to death due to any cause. OS will be presented.