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