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Compares treatment options for Endometrial Cancer
Official 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)
ClinicalTrials.gov ID: NCT06952504
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endometrial cancer.
Also referred to as KEYTRUDA®, MK-3475.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Key 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...
- Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per Response...
- Has received no prior systemic therapy for endometrial carcinoma except the following conditions as pre-specified by the protocol: 1 prior line of...
You likely can't join if
- 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...
- Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that...
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
See the full eligibility criteria
- Key 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Anchorage, Alaska, United States
- Irvine, California, United States
- Orange, California, United States
- Walnut Creek, California, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Fort Myers, Florida, United States
- Gainesville, Florida, United States
- Miami Beach, Florida, United States
- Orlando, Florida, United States
- St. Petersburg, Florida, United States
- West Palm Beach, Florida, United States
- Savannah, Georgia, United States
- Chicago, Illinois, United States
- Fort Wayne, Indiana, United States
- Covington, Louisiana, United States
- Shreveport, Louisiana, United States
- Scarborough, Maine, United States
- Boston, Massachusetts, United States
+ 206 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mobile, Alabama, United States; Anchorage, Alaska, United States; Irvine, California, United States; Orange, California, United States; Walnut Creek, California, United States; New Haven, Connecticut, United States and 220 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.