New combo therapy for endometrial cancer shows promise in early trial
NCT ID NCT03932409
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial is testing whether adding the immunotherapy drug pembrolizumab to standard radiation and chemotherapy is safe and feasible for people with high-intermediate risk endometrial cancer. About 45 participants who have already had surgery to remove the uterus will receive radiation to the vagina, followed by three cycles of pembrolizumab plus chemotherapy. The main goal is to see how many people can complete all three cycles of the combined treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2020
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. All patients must have undergone hysterectomy. Bilateral salpingooophorectomy is strongly encouraged but not mandatory. 2. Pelvic and para-aortic lymphadenectomy are optional, but strongly encouraged. 3. If either a bilateral salpingo-oophorectomy (BSO) or nodal sampling was not performed, post-operative pre-treatment CT/MRI is required and must not demonstrate evidence suggestive of metastatic disease (adnexa, nodes, intraperitoneal disease). Post-operative, pre-treatment CT/MRI must be performed if a BSO and/or lymphnode sampling was not performed. 4. Tissue from an archival sample or newly obtained core or excisional biopsy of a tumor lesion within 10 weeks confirming diagnosis. 5. All patients will be staged according to the FIGO 2009 staging system and with endometrial carcinoma (endometrioid types) confined to the corpus uteri or with endocervical glandular involvement fitting one of the following high-intermediate risk factor categories: * age ≥18 years with 3 risk factors * Risk factors: 1. Grade 2 or 3 tumor, (+) lymphovascular space invasion, outer ½ myometrial invasion. Patients with these risk criteria may be enrolled with either positive or negative cytology. 2. Patients with Stage II endometrial carcinoma (any histology) with cervical stromal invasion (occult or gross involvement), with or without high-intermediate risk factors. 3. Patients with serous or clear cell histology (with or without other high-intermediate risk factors) are eligible provided the disease is Stage I or II (with or without cervical stromal invasion or endocervical glandular involvement). Eligibility for clear cell and serous histology is not based on presence of lymphovascular space invasion or depth of invasion. 6. Patients must have ECOG performance status 0 or 1. 7. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial and authorization permitting release of personal health information. 8. Neuropathy (sensory and motor) ≤ Grade 1. 9. Have adequate organ function as defined per Protocol. Exclusion Criteria: 1. Patients with recurrent disease. 2. Greater than 12 weeks elapsed from surgery to enrollment 3. Patients have prior pelvic or abdominal radiation therapy 4. Known hypersensitivity to any component of study treatments that resulted in drug discontinuation 5. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor 6. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks \[could consider shorter interval for kinase inhibitors or other short half-life drugs\] prior to allocation. 7. Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease. 8. Has received a live vaccine within 30 days prior to the first dose of study drug. 9. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. 10. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. 11. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. 12. Has known active CNS metastases and/or carcinomatous meningitis. 13. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. 14. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 15. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. 16. Has an active infection requiring systemic therapy. This excludes grade 2 urinary tract infections or grade 1-2 skin infections. 17. Has a known history of Human Immunodeficiency Virus (HIV). 18. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. 19. Has a known history of active TB (Bacillus Tuberculosis). 20. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 21. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 22. Is pregnant or breastfeeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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LSU Health New Orleans
New Orleans, Louisiana, 70112, United States
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Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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