Lenvatinib, Pembrolizumab, and Radiation for Recurrent Endometrial Cancer
This study is testing a combination of treatments for recurrent or unresectable endometrial carcinoma (cancer of the uterus lining that has come back or cannot be removed by surgery). You may be eligible if you are a woman aged 18 or older with biopsy-proven recurrent pMMR EC (a specific type of endometrial cancer) or de novo unresectable pMMR EC, and your doctor has determined that radiation therapy is appropriate. The study will combine daily oral Lenvatinib capsules, Pembrolizumab given intravenously (into a vein) every three weeks, and a short course of hypofractionated pelvic radiation therapy (a type of radiation given in fewer, larger doses). The main goals are to find the recommended dose of Lenvatinib for future studies and to track any treatment-related side effects within the first 12 weeks. The current recruitment status is unclear, and the study plans to enroll 18 participants.
- Study design
- This is an interventional study, but the phase is not specified. It plans to enroll 18 participants.
- What's involved
- You would take Lenvatinib capsules daily, receive Pembrolizumab intravenously every three weeks, and undergo hypofractionated pelvic radiation therapy starting on Day 22 for a total of 16 fractions.
- Compensation
- Not stated in the trial record.
- Follow-up
- Treatment-related toxicity will be measured for up to 12 weeks, and the recommended Phase 2 Dose of Lenvatinib will be measured for up to 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 1 Clinical Trial of Lenvatinib, Pembrolizumab and Hypofractionated Pelvic Radiation Therapy for pMMR Recurrent/Unresectable Endometrial Carcinoma
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Aaron H Wolfson, MD, FACR · PRINCIPAL_INVESTIGATOR · University of Miami
Who to contact
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What this trial measures
- Recommended Phase 2 Dose (RP2D) of LenvatinibUp to 12 weeks
The RP2D will be the highest dose of Lenvatinib that in combination with Pembrolizumab and Hypofractionated (HypoFx) pelvic External Beam Radiotherapy (EBRT) yields less than 2 Dose Limiting Toxicities (DLTs) in 6 patients.
- Number of Participants Experiencing Treatment-Related Toxicity: Dose-Limiting Toxicities (DLTs)Up to 12 weeks
The number of participants experiencing treatment-related DLTs will be reported. DLTs will be assessed by the treating physician using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
- Number of Participants Experiencing Treatment-Related Toxicity: Adverse Events (AEs)Up to 12 weeks
The number of participants experiencing treatment-related adverse events (AEs) will be reported. AEs will be assessed by the treating physician using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.