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Looking for participantsPhase3

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)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT07216703

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Pembrolizumab (biological), Sacituzumab Tirumotecan (biological), Bevacizumab (biological), Paclitaxel (drug)
How long the study runs
Study runs about 69 months (dates as stated)
About the drug or intervention
Pembrolizumab — biological: Intravenous (IV) Infusion · Sacituzumab Tirumotecan — biological: IV Infusion · Bevacizumab — biological: IV Infusion · Paclitaxel — drug: IV Infusion · Cisplatin — drug: IV Infusion · Carboplatin — drug: IV Infusion · Rescue Medications — drug: Participants will receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent, prophylactic steroid mouthwash (dexamethasone or equivalent), and granulocyte colony-stimulating factor (G-CSF).
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
Female
Number of participants
1,023
Started
2026-01-19
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for cervical cancer
  • • Phase3 - 1,023 participants
  • • Researchers are looking for new ways to treat metastatic cervical cancer

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with cervical cancer
  • • Female only

Where?

  • • Edinburgh - Western General Hospital ( Site 3604)
  • • Truro - The Royal Cornwall Hospital ( Site 3606)
  • • London - University College Hospital London ( Site 3605)
  • • Withington - The Christie Hospital NHS Foundation Trust ( Site 3602)

This is a simplified summary. Always discuss with your doctor before making any decisions.

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

More detail

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 induction treatment. Eligible participants whose cancer does not progress then begin maintenance treatment and are randomized to receive pembrolizumab or sac-TMT + pembrolizumab. All participants in Part 2 maintenance treatment may also receive bevacizumab at the investigator's discretion.

Cervical Cancer

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What we know so far

Condition· Matched your search
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only

Biomarkers mentioned

If positivecombined positive

Treatment history

Treatments you must have had:

  • ✓ active treatment within the past 3 years
  • ✓ systemic treatment in the past 2 years

What the study is looking for

  • ✓The main inclusion criteria include but are not limited to the following:
  • ✓Has a confirmed by a biopsy diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of...
  • ✓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...
  • ✓If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
See the full 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 Is This Study? (4 UK sites)

Western General Hospital ( Site 3604)

Edinburgh EH4 2XU, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441315371000

The Royal Cornwall Hospital ( Site 3606)

Truro TR1 3LJ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01872 258344

University College Hospital London ( Site 3605)

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator0044 203 447 8025

The Christie Hospital NHS Foundation Trust ( Site 3602)

Withington M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441619187682

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10