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

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

Age range

18+ years

Sex

Female

Healthy volunteers

No

Interventions

• 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.

• Radiation
  High-Dose Rate (HDR) Brachytherapy

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

Location