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)
Unknown Primary
Uterine Cancer
18 Years and older, Male and Female
2870-033 (primary)
NCI-2025-04722
2024-519331-42-00
ENGOT-en29
GOG-3119
jRCT2011250020
TroFuse-033
U1111-1315-0794
Summary
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.
Objectives
All participants undergo an initial Induction Phase of six cycles, each cycle consisting
of pembrolizumab + carboplatin + 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.
Eligibility
- 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 curative-intent 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
Treatment Sites in Georgia
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