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Looking for participantsPhase3

A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06952504

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), Carboplatin (drug), Paclitaxel (drug), Docetaxel (drug)
How long the study runs
Study runs about 84 months (dates as stated)
About the drug or intervention
Pembrolizumab — biological: Intravenous (IV) Infusion · Carboplatin — drug: During the Induction Phase, participants receive carboplatin AUC 5 (mg/mL/min) on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion. · Paclitaxel — drug: During the Induction Phase, participants receive paclitaxel 175 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion. · Docetaxel — drug: During the Induction Phase, participants may receive docetaxel (in place of paclitaxel) 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion. · Sacituzumab Tirumotecan — biological: IV Infusion · Cisplatin — drug: During the Induction Phase, participants may receive cisplatin (in place of carboplatin) 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
Female
Number of participants
1,123
Started
2025-05-22
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for endometrial cancer
  • • Phase3 - 1,123 participants
  • • Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent

Who can take part?

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

Where?

  • • East Sussex - University Hospitals Sussex NHS Foundation Trust ( Site 4011)
  • • Cambridge - Addenbrookes Hospital ( Site 4002)
  • • Glasgow - The Beatson West of Scotland Cancer Centre ( Site 4004)
  • • London - University College London Hospital ( Site 4001)
  • • +7 more UK sites

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 people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent. * EC is a type of cancer that starts in the tissues inside the uterus (womb) * pMMR indicates that certain normal proteins are present in the cancer cells * Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery * Recurrent means the cancer came back after surgery Sacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines. Sac-TMT is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goal of this study is to learn if people who receive sac-TMT with pembrolizumab live longer and without the cancer getting worse compared to people who receive pembrolizumab alone.

More detail

All participants undergo an initial Induction Phase of six cycles, each cycle consisting of pembrolizumab + carboplatin or cisplatin + paclitaxel or docetaxel. Each cycle is three weeks. Participants whose cancer does not progress enter the Maintenance Treatment Phase and are then randomly assigned to pembrolizumab + sac-TMT or pembrolizumab monotherapy. Participants whose cancer does progress will have the possibility to enter the Subsequent Treatment Phase and are then randomly assigned to pembrolizumab + sac-TMT or sac-TMT monotherapy.

Endometrial Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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

Treatment history

Treatments you must have had:

  • ✓ of systemic platinum-based adjuvant
  • ✓ in any setting with any of the following: anti-programmed cell death 1 protein

What the study is looking for

  • ✓Key inclusion criteria include but are not limited to:
  • ✓Has a confirmed by a biopsy diagnosis of primary advanced or recurrent endometrial carcinoma that has been...
  • ✓Key exclusion criteria include but are not limited to:
  • ✓Has carcinosarcoma, neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma,...
  • ✓Has endometrial carcinoma of any histology that is mismatch repair deficient (dMMR)
See the full criteria
Key inclusion criteria include but are not limited to: * Has a histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that has been confirmed as proficient mismatch repair (pMMR) * Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator * Has received no prior systemic therapy for endometrial carcinoma except the following conditions as pre-specified by the protocol: 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent, prior radiation with or without radiosensitizing chemotherapy if \>2 weeks before the start of induction treatment, or prior hormonal therapy for treatment of endometrial carcinoma that was discontinued ≥1 week before the start of induction treatment Key exclusion criteria include but are not limited to: * Has carcinosarcoma, neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of sarcomas * Has endometrial carcinoma of any histology that is mismatch repair deficient (dMMR) * Is a candidate for debulking surgery resulting in complete removal of all tumor and no evidence of radiological disease following surgery, or curative-intent radiotherapy at the time of enrollment * 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 * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease * Human Immunodeficiency Virus-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Received prior therapy in any setting with any of the following: anti-programmed cell death 1 protein, anti-programmed cell death ligand 1, anti-programmed cell death ligand 2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor; trophoblast cell surface antigen 2-targeted antibody drug conjugate; or topoisomerase I inhibitor-containing antibody drug conjugate

Where Is This Study? (11 UK sites)

University Hospitals Sussex NHS Foundation Trust ( Site 4011)

East Sussex BN2 1ES, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01273696955

Addenbrookes Hospital ( Site 4002)

Cambridge CB2 0QQ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441223805000

The Beatson West of Scotland Cancer Centre ( Site 4004)

Glasgow G12 0YN, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator(0) 141 301 7207

University College London Hospital ( Site 4001)

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+442034477807

ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 4006)

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator02073528171

Hammersmith Hospital ( Site 4010)

London W12 0HS, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+443000330333

Western General Hospital ( Site 4012)

Edinburgh EH4 2XU, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441315371000

Royal Marsden Hospital (Sutton) ( Site 4005)

London SM3 5PT, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator02073528171

Leicester Royal Infirmary ( Site 4008)

Leicester LE1 5WW, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+443003031573

Maidstone Hospital ( Site 4007)

Maidstone ME16 9QQ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441622729000

The Christie NHS Foundation Trust ( Site 4003)

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441614463000

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