Pembrolizumab and Lenvatinib in Advanced Cervical Cancer
Trial Parameters
Brief Summary
This is a phase II trial of combination therapy of pembrolizumab and lenvatinib in patients with locally advanced or metastatic cervical cancer that had failed first line of therapy. The hypothesis is the combination of lenvatinib and pembrolizumab will overcome vascular endothelial growth factor (VEGF)-mediated immunosuppression to enhance the response of patients with locally advanced or metastatic cervical cancer.
Eligibility Criteria
Inclusion Criteria: 1. Female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of locally advanced or metastatic cervical cancer will be enrolled in this study. 2. Patients with progression or intolerance to at least one line of therapy in the locally advanced or metastatic setting will be eligible for this study. 3. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP) as defined OR 2. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment. 4. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. 5. Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable