Phase 2 Open-Label Trial Investigating the Efficacy and Safety of Pembrolizumab and Lenvatinib in Mismatch Repair Proficient Recurrent Endometrial Cancer After Failure of First-Line Therapy With Platinum-based Doublet and Immunotherapy
University of Miami
Summary
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
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Histologically confirmed recurrent endometrial carcinoma, including serous, endometrioid, carcinosarcoma, clear cell subtypes, with measurable disease per RECIST 1.1 criteria. 2. Mismatch repair (MMR) proficient status confirmed by IHC (Immunohistochemistry) or molecular testing. 3. Patients must have failed first-line therapy with platinum based doublet with prior immunotherapy. 4. Patient must have completed next-generation sequencing on either primary or recurrent tumor. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3. 6. Age ≥ 18 years. 7. F…
Interventions
- DrugPembrolizumab
Participants will receive 200mg of Pembrolizumab intravenously on Day 1 of every 21 day cycle, as per standard of care and as per institutional guidelines.
- DrugLenvatinib
Participants will self-administer Lenvatinib orally at a daily dose of 20mg or every 21 day cycle, as per standard of care and as per institutional guidelines.
Location
- University of MiamiMiami, Florida