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RecruitingPhase 3

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)

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests sacituzumab tirumotecan (sac-TMT) with pembrolizumab versus pembrolizumab alone for cancer of the uterus (womb) that has spread and cannot be removed by surgery, or has come back. It is for people with pMMR cancer, meaning certain normal proteins are present in the cancer cells. Researchers want to see if the two medicines help people live longer and keep the cancer from getting worse.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A tissue test must confirm advanced or returned cancer of the womb with pMMR.
  • Cancer must be checked with scans. Stage III cancer must be measurable; Stage IV or returned cancer may be measurable or not.
  • Usually, you must not have had medicine that treats womb cancer throughout the body. Some past treatments are allowed under the study rules.
  • One past course of platinum-based chemotherapy before or after surgery may be allowed if it was given with the aim of curing the cancer.
  • Past radiation, with or without chemotherapy to help it work, may be allowed if it ended more than 2 weeks before the study's starting treatment.
  • Past hormone treatment for womb cancer may be allowed if it stopped at least 1 week before the study's starting treatment.

Who can't join

  • Certain tumor types: carcinosarcoma, neuroendocrine tumors, or endometrial sarcomas, including stromal sarcoma, leiomyosarcoma and adenosarcoma.
  • Cancer with dMMR, meaning its system for fixing errors in DNA does not work properly.
  • You could have surgery to remove all tumors with no cancer left on scans, or radiation aimed at curing the cancer.
  • A history of severe dry eyes, severe problems with eyelid oil glands or eyelid swelling, or severe disease of the eye's clear front layer that slows healing.
  • Current bowel inflammation that needs medicine to lower immune activity, or any past inflammatory bowel disease.
  • Serious heart, blood vessel or brain blood vessel disease that is not controlled.
  • HIV infection with a history of Kaposi's sarcoma or multicentric Castleman's disease.
  • Past treatment with certain immune medicines targeting PD-1, PD-L1, PD-L2 or other T-cell switches; or antibody-linked cancer medicines targeting TROP2 or carrying a topoisomerase I blocker.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (53)

AK

AL

CA

CT

DC

FL

GA

IL

IN

LA

MA

ME

MN

MO

MS

NC

NJ

NM

NV

NY

OH

OK

OR

PA

RI

TN

TX

VA