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Sacituzumab tirumotecan plus pembrolizumab as first-line maintenance for metastatic cervical cancer

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)

PHASE3 · Merck Sharp & Dohme LLC · NCT07216703

This trial tests whether adding the antibody-drug conjugate sacituzumab tirumotecan to pembrolizumab (with or without bevacizumab) as maintenance treatment can help people with metastatic cervical cancer live longer or keep the cancer from growing.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment1023 (estimated)
Ages18 Years and up
SexFemale
SponsorMerck Sharp & Dohme LLC (industry)
Drugs / interventionsradiation, sacituzumab, pembrolizumab, bevacizumab
Locations91 sites (Miami Beach, Florida and 90 other locations)
Trial IDNCT07216703 on ClinicalTrials.gov

What this trial studies

This is a two-part, randomized Phase 3 trial with an initial safety run-in where participants receive sacituzumab tirumotecan, pembrolizumab, and bevacizumab. In the main randomized phase, all participants first receive standard induction therapy; those whose disease does not progress are randomized to maintenance treatment with pembrolizumab alone or sacituzumab tirumotecan plus pembrolizumab, with bevacizumab allowed at the investigator's discretion. The study will track safety, overall survival, and progression-free survival to compare the maintenance strategies. Treatment involves regular infusions and scheduled clinical and imaging follow-up to monitor response and side effects.

Who should consider this trial

Good fit: Ideal candidates are adults with metastatic (FIGO IVB) squamous, adenosquamous, or adenocarcinoma of the cervix with PD-L1 combined positive score ≥1, ECOG performance status 0–1, and no progression after standard induction therapy.

Not a fit: Patients who have poor performance status, rapidly progressing disease during induction, PD-L1 negative tumors, uncontrolled infections, or contraindications to the study drugs are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could extend how long people live or delay cancer growth compared with current maintenance options.

How similar studies have performed: TROP2-targeted antibody-drug conjugates and PD-1 inhibitors have shown promise in other solid tumors and early-phase combinations, but this exact combination as maintenance in cervical cancer is novel and being tested in a Phase 3 setting.

Eligibility criteria

Show full inclusion / exclusion 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 (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

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 (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

Where this trial is running

Miami Beach, Florida and 90 other locations

+41 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Cervical Cancer, Programmed Cell Death-1, Programmed Cell Death 1 Ligand 1, Programmed Cell Death 1 Ligand 2, Trophoblast Cell Surface Antigen 2

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.