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

PHASE1RecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

April 15, 2023

Primary Completion Date

April 15, 2027

Study Completion Date

April 15, 2030

Conditions
Recurrent Endometrial CarcinomaUnresectable Endometrial Carcinoma
Interventions
DRUG

Lenvatinib

Lenvatinib capsules taken daily by mouth

DRUG

Pembrolizumab

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

RADIATION

Hypofractionated 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.

Trial Locations (1)

33136

RECRUITING

University of Miami, Miami

All Listed Sponsors
lead

Aaron Wolfson

OTHER