🏛️ Verified NIH Record • Updated 2026-07-30
Phase 1 Clinical Trial of Lenvatinib, Pembrolizumab and Hypofractionated Pelvic Radiation Therapy for pMMR Recurrent/Unresectable Endometrial Carcinoma (NCT05603910)
🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Aaron Wolfson
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this research study is to see if it is feasible to combine a fixed dose of pembrolizumab and a daily dose of oral lenvatinib, along with daily treatments of an abbreviated course of pelvic external beam radiation therapy, to support cancer cells in multiplying and spreading to other body sites.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (17 items) and avoid the listed exclusions (26 items).
Location: University of Miami — Miami, Florida
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients who are currently in or have participated in a study of an investigational agent or used an investigational device within 4 weeks of the first dose of study treatment.
- Patients with Mismatch repair deficient (dMMR) and endometrial carcinomas.
- Patients with dMMR and uterine carcinosarcomas.
- Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis. EXCEPTION: Patients with previously treated brain metastases, including receiving prior brain irradiation, may participate provided they are stable (without evidence of progression by imaging for at least 3 months prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, are not using steroids for at least 28 days prior to study treatment, and have not received prior cranial irradiation for at least 3 months prior to study treatment.
- Patients with a known additional malignancy that is progressing or requires active treatment. EXCEPTIONS include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- No prior external beam radiation therapy to the vagina, pelvis, and/or abdomen will be allowed.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other serious medical condition or social situations that in the judgement of the Investigator(s) would interfere or limit compliance with study requirements/treatments.
- Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 21 days prior to the first dose of study treatment. Note: Patients with 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) and/or requiring replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Evidence of uncontrolled hypertension as documented in the patient's medical record.
- Known psychiatric illness/condition or substance abuse disorders that in the judgement of the Investigator(s) would interfere with cooperation with requirements of the study.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Miami — Miami, Florida
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.