University of Texas Southwestern Medical Center
The main purpose of this study is to gather information about an investigational drug combination, Lenvatinib in combination with pembrolizumab, that may help to treat cervical cancers. In this study, we are looking to see whether the combination of lenvatinib and pembrolizumab has any effect on slowing tumor growth in cervical cancer tumors.
Dose of pembrolizumab : The planned dose of pembrolizumab for this study is 200 mg every 3 weeks (Q3W). for a total of 35 cycles of pembrolizumab. Participants who complete study intervention after 2 years of pembrolizumab are eligible for up to 1 year of additional pembrolizumab (second course) upon experiencing disease progression. Lenvatinib Dosing Regimen: lenvatinib 20 mg/day plus pembrolizumab 200 mg Q3W.
Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: 1. Female participants who are at least 18 years of age on the day of signing informed consent. 2. Histologically confirmed diagnosis of squamous, adenocarcinoma or adenosquamous cervical cancer, that is recurrent or metastatic. 3. Prior therapy: May have received up to 2 prior lines of systemic chemotherapy in the setting of advanced, metastatic (Stage IVB) or recurrent cervical cancer. May have received prior checkpoint inhibitor for advanced, metastatic (Stage IVB) or recurr…
200 mg IV q 3 weeks
20 mg PO daily
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