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
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.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3.
• Age ≥ 18 years.
• Female participants must be of non-childbearing potential or for females of child bearing potential (FOCBPs), must agree to use contraception as described in Section 5.6. FOCBPs must not be pregnant or breastfeeding.
• At least one measurable lesion according to RECIST 1.1.
• Adequate organ function, including:
‣ Hemoglobin ≥ 8 g/dL (blood transfusions are permitted)
⁃ Absolute neutrophil count ≥ 1000
⁃ Platelet count ≥ 100 x 10⁹/L
⁃ Glomerular filtration rate (GFR) ≥ 30 mL/min
⁃ Bilirubin ≤ 1.5 x ULN (upper limit of normal)
⁃ Written informed consent obtained from the patient.
⁃ At least 3 weeks must have elapsed from any prior therapy