RecruitingPhase 1NCT05603910

Phase 1 Clinical Trial of Lenvatinib, Pembrolizumab and Hypofractionated Pelvic Radiation Therapy for pMMR Recurrent/Unresectable Endometrial Carcinoma

Phase 1 Clinical Trial of Lenvatinib, Pembrolizumab and Hypofractionated Pelvic Radiation Therapy for Mismatch Repair Proficient (pMMR) Recurrent/Unresectable Endometrial Carcinoma


Sponsor

Aaron Wolfson

Enrollment

18 participants

Start Date

Apr 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 study tests a combination of two immunotherapy/targeted therapy drugs — lenvatinib and pembrolizumab — together with focused pelvic radiation for women with endometrial (uterine) cancer that has come back or cannot be surgically removed. The cancer must be of a type that lacks certain DNA repair proteins (called pMMR), which typically responds less well to standard immunotherapy alone. **You may be eligible if...** - You have recurrent or unresectable endometrial cancer confirmed by biopsy - Your cancer is pMMR (a specific molecular type determined by testing) - You have already had surgery, or your cancer cannot be surgically removed - Radiation therapy has been determined to be appropriate for your situation - Your general health and organ function meet required levels **You may NOT be eligible if...** - Your cancer is the dMMR/MSI-high type (a different molecular subtype) - You have had prior pelvic radiation that overlaps with the planned treatment area - You have autoimmune conditions or are on immunosuppressive treatment - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLenvatinib

Lenvatinib capsules taken daily by mouth

DRUGPembrolizumab

200 mg Pembrolizumab administered intravenously (IV) once on Days 1, 22 and 43.

RADIATIONHypofractionated External Beam Radiation Therapy

HypoFx whole pelvic EBRT begins on Day 22 and continues for a total of 16 fractions of radiation given at a dose of 2.5 Gy per fraction for a total dose of 40.0 Gy delivered to the pelvis. A pelvic boost HypoFx EBRT consisting of 7 fractions of radiation given at a dose of 2.5 Gy per fraction that will be delivered to site(s) of gross disease of at least 1.0 cm in size. An additional boost total dose of 17.5 Gy administered will be administered over a period of 1.5 to 2.0 weeks.


Locations(1)

University of Miami

Miami, Florida, United States

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NCT05603910


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