Tests sacituzumab tirumotecan with pembrolizumab in endometrial cancer
Tests sacituzumab tirumotecan plus pembrolizumab in adults with advanced endometrial cancer.
Key facts
- Who runs it
- Merck Sharp & Dohme LLC
- Where
- Aguascalientes, Chihuahua City, Guadalajara, Monterrey, and Oaxaca City, MexicoSee the 5 sitesAlso in 33 other countries, 272 sites
- Trial code
- NCT06952504
- EU 2024-519331-42-00
- JRCT2011250020
- U1111-1315-0794
- Registry title
- 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)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 1,123 people, planned
- Started
- 22 May 2025
- Expected to end
- 24 May 2032
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Pembrolizumab
- Carboplatin
- Paclitaxel
- Docetaxel
- Sacituzumab Tirumotecan
- Cisplatin
- Record updated
- 10 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with advanced or recurrent endometrial cancer whose cancer cells are mismatch repair proficient (pMMR). It compares sac-TMT with pembrolizumab against pembrolizumab alone.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Primary advanced or recurrent endometrial carcinoma, confirmed as pMMR. Measurable Stage III, or measurable or non-measurable Stage IV or recurrent disease.
- Earlier treatment
- No earlier systemic therapy for endometrial cancer, with set exceptions: 1 earlier line of platinum-based chemotherapy given before or after surgery with the aim of removing all the disease, earlier radiation, or earlier hormonal therapy stopped at least 1 week before.
- Biomarker or test result
- The cancer must be proficient mismatch repair (pMMR).
Main reasons for not taking part
- Carcinosarcoma, neuroendocrine tumors or endometrial sarcoma
- Cancer that is mismatch repair deficient (dMMR)
- Can have surgery that removes all tumor, or radiotherapy meant to remove all the disease
- Severe dry eye, severe eyelid gland disease or severe corneal disease
- Earlier treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, TROP2-targeted antibody drug conjugates, or topoisomerase I inhibitor antibody drug conjugates
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel 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
- 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 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
- 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)
Where in Mexico
Also in 33 other countries, 272 sites
- Centro de Investigación Oncológica Galerías SC (Site 2405)Aguascalientes, MexicoContact: Study CoordinatorTaking people
- Sitio Clínico UIS Chihuahua (Operadora Unidad de Investigación en Salud de Chihuahua SA de CV) (Site 2406)Chihuahua City, MexicoContact: Study CoordinatorTaking people
- CIO - Centro de Inmuno-Oncología de Occidente (Site 2402)Guadalajara, MexicoContact: Study CoordinatorTaking people
- Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" (Site 2401)Monterrey, MexicoContact: Study CoordinatorTaking people
- Centro de Investigacion Clinica de Oaxaca (Site 2404)Oaxaca City, MexicoContact: Study CoordinatorTaking people
About the trial
What the trial wants to find out
Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent.
Read full original descriptionShow less
* 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.
The 4 groups in the trial
- Maintenance Treatment Arm A: Pembrolizumab + Sacituzumab TirumotecanTreatment being tested
During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin area under the curve (AUC) 5 (mg/mL/min) or cisplatin 75 mg/m\^2, and paclitaxel 175 mg/m\^2 or docetaxel 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Maintenance Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle and pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months).
Treatment: Pembrolizumab, Carboplatin, Paclitaxel, Docetaxel, Sacituzumab Tirumotecan, and Cisplatin
- Maintenance Treatment Arm B: Pembrolizumab MonotherapyExisting treatment, for comparison
During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min) or cisplatin 75 mg/m\^2, and paclitaxel 175 mg/m\^2 or docetaxel 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Maintenance Treatment Phase, participants receive pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months).
Treatment: Pembrolizumab, Carboplatin, Paclitaxel, Docetaxel, and Cisplatin
- Subsequent Treatment Arm A: Pembrolizumab + Sacituzumab TirumotecanTreatment being tested
During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min) or cisplatin 75 mg/m\^2, and paclitaxel 175 mg/m\^2 or docetaxel 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Subsequent Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle until discontinuation criteria is met and pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months).
Treatment: Pembrolizumab, Carboplatin, Paclitaxel, Docetaxel, Sacituzumab Tirumotecan, and Cisplatin
- Subsequent Treatment Arm B: Sacituzumab Tirumotecan MonotherapyExisting treatment, for comparison
During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min) or cisplatin 75 mg/m\^2, and paclitaxel 175 mg/m\^2 or docetaxel 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Subsequent Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle until discontinuation criteria is met.
Treatment: Carboplatin, Paclitaxel, Docetaxel, Sacituzumab Tirumotecan, and Cisplatin
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 3 Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (TroFuse-033/GOG-3119/ENGOT-en29)
- Plain-language title
- Tests sacituzumab tirumotecan with pembrolizumab in endometrial cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 10 November 2026