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

NCT05603910 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-08-03

No results posted yet for this study

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.

Conditions

  • Recurrent Endometrial Carcinoma
  • Unresectable Endometrial Carcinoma

Interventions

RADIATION

High-Dose Rate (HDR) Brachytherapy

Vaginal high-dose rate (HDR) brachytherapy administered per standard of care (SoC) techniques.

DRUG

Lenvatinib

Lenvatinib will be self-administered orally (PO) by participants in a 3+3 escalation/de-escalation design. Participants will receive one of the following four dose levels: * Dose level 1: 4 mg * Dose level 2: 8 mg * Dose level 3: 12 mg (Starting dose) * Dose level 4: 16 mg

DRUG

Pembrolizumab

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

RADIATION

Hypofractionated External Beam Radiation Therapy

Whole pelvic HypoFx EBRT consisting of 16 fractions of radiation given at a dose of 2.5 Gy per fraction for a total dose of 40.0 Gy. A pelvic boost HypoFx EBRT consisting of 7 fractions of radiation given at a dose of 2.5 Gy per fraction for a total dose of 17.5 Gy, delivered to site(s) of gross disease of at least 1.0 cm in size.

Sponsors & Collaborators

  • Aaron Wolfson

    lead OTHER

Principal Investigators

  • Aaron H Wolfson, MD, FACR · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-15
Primary Completion
2029-04-15
Completion
2034-04-15
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05603910 on ClinicalTrials.gov