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 capsules taken daily by mouth
  • Pembrolizumab — DRUG
    200 mg Pembrolizumab administered intravenously (IV) once on Days 1, 22 and 43.
  • Hypofractionated External Beam Radiation Therapy — RADIATION
    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.

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

Start date
Apr 15, 2023
Status verified
Feb 2026
Primary completion
Apr 15, 2027
Completion
Apr 15, 2030

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. 1. Lenvatinib - administered in a 3 plus 3 escalation/de-escalation design. Participants will receive 1 of 4 of the following dose levels: Dose level 1- 4 mg Dose level 2- 8 mg Dose level 3 (Starting dose) - 12 mg Dose level 4- 16 mg 2. Pembrolizumab- 200 mg IV will be administered on Day 1, 22 and 43 3. 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.

Primary Outcome Measure

Recommended Phase 2 Dose (RP2D) of Lenvatinib [ Time Frame: Up to 1 year ]

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)

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By research site
University of Miami· Miami, FL

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