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

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.

Trial Details

NCT ID
NCT05603910
Phase
PHASE1
Sponsor
Aaron Wolfson
Status
RECRUITING
Cancer Type
Uterine Cancer
Interventions
  • Lenvatinib
  • Pembrolizumab
  • Hypofractionated External Beam Radiation Therapy
  • High-Dose Rate (HDR) Brachytherapy
Locations (sample)
  • Miami, Florida, United States|25.77427,-80.19366

Key Eligibility Criteria

  • Biopsy-proven recurrent pMMR EC following surgery alone or de novo unresectable pMMR EC for whom EBRT has been determined as an appropriate therape…
  • Measurable disease of at least 1.0 cm in size defined by RECIST 1.1 on imaging studies with at least one (1) site located in the pelvis and/or vagi…
  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Karnofsky score ≥50).
  • Patients must have pMMR tumor subtype(s).

For full eligibility, visit ClinicalTrials.gov.

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