Pembrolizumab and Lenvatinib in Mismatch Repair Proficient Recurrent Endometrial Cancer After Failure of First-Line Therapy With Platinum-based Doublet and Immunotherapy

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Miami

About this trial

The purpose of this study is to determine the efficacy and safety of Pembrolizumab in combination with Lenvatinib in recurrent, mismatch repair-proficient endometrial cancer after failure of first-line therapy with a platinum-based doublet chemotherapy and immunotherapy.

Eligibility criteria

Qualifiers

Histologically confirmed recurrent endometrial carcinoma, including serous, endometrioid, carcinosarcoma, clear cell subtypes, with measurable disease per RECIST 1.1 criteria.

Mismatch repair (MMR) proficient status confirmed by IHC (Immunohistochemistry) or molecular testing.

Patients must have failed first-line therapy with platinum based doublet with prior immunotherapy.

Patient must have completed next-generation sequencing on either primary or recurrent tumor.

Disqualifiers

Uterine sarcoma

Active central nervous system metastases or leptomeningeal disease.

History of severe allergic reactions to pembrolizumab, lenvatinib, or any components of the formulations.

Active autoimmune disease requiring chronic systemic steroids for > 3 months in the last 6 months prior to enrollment.

Trial design

Treatments tested in this trial

  • Pembrolizumab
  • Lenvatinib

Treatment groups

46 Participants
are divided into 1 treatment group

Sponsors and collaborators