Georgetown University
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.
The primary endpoint of this phase II study is to determine the objective response rate (partial response \[PR\] + complete response \[CR\]) of specific pembrolizumab-lenvatinib combination therapy in patients with locally advanced or metastatic cervical cancer. The phase II portion of the trial will follow Simon's minimax two-stage design1. In the Stage 1, 11 patients will be accrued. If 1 or fewer patients among these 11 patients achieve an objective response with the pembrolizumab-lenvatinib combination therapy, the combination therapy will be rejected and the trial stopped. However, if th…
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 def…
200mg, every 3 weeks, IV infusion
20 mg (2 capsules x10mg), daily, orally
Arctuva estimate
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