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

Part of paid clinical trials in Miami, Florida.

Sponsor
Aaron Wolfson
Study ID
NCT05603910
Phase
PHASE1
Status
Recruiting
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Conditions

  • Recurrent Endometrial Carcinoma
  • Unresectable Endometrial Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenvatinib — DRUG
    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
  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg will be administered intravenously (IV) once on Days 1, 22 and 43.
  • Hypofractionated External Beam Radiation Therapy — RADIATION
    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.
  • High-Dose Rate (HDR) Brachytherapy — RADIATION
    Vaginal high-dose rate (HDR) brachytherapy administered per standard of care (SoC) techniques.

Study Details

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.

Key Dates

First listed
Nov 3, 2022
Start date
Apr 15, 2023
Status verified
Jul 2026
Primary completion
Apr 15, 2029
Completion
Apr 15, 2034

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lenvatinib, Pembrolizumab and Hypofractionated (HypoFx) External Beam Radiation Therapy (EBRT) Group
    Participants in this group will receive a combination treatment of Lenvatinib, Pembrolizumab, and HypoFx Pelvic EBRT over a period of approximately 10 to 12 weeks: * Lenvatinib self-administered daily starting on Day 1 of the study treatment period and continuing until the last dose of whole pelvic HypoFx EBRT is received. * Pembrolizumab administered on Day 1, 22 and 43. * Whole pelvic HypoFx EBRT beginning on Day 22. After receiving whole pelvic Hypo EBRT, participants will receive a boost course of radiation therapy using one of the following techniques: * Pelvic boost HypoFx EBRT to be administered over a period of 1.5 to 2 weeks; OR * Vaginal HDR brachytherapy boost to be administered over a period of 2 to 3 weeks, depending on the lesion thickness; OR * Both pelvic boost HypoFx EBRT pelvic plus vaginal HDR brachytherapy boost. The overall radiation therapy treatment time for whole pelvic HypoFx RT and radiation boost treatments is approximately 7 weeks.

Primary Outcome Measure

Recommended Phase 2 Dose (RP2D) of Lenvatinib [ Time Frame: Up to 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Aaron H Wolfson, MD, FACR
[email protected]
954-698-3680
Aaron H Wolfson, MD, FACR (PRINCIPAL_INVESTIGATOR)
Matthew Sclhumbrecht, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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