Drug: Cabozantinib Drug: Pembrolizumab
This study is a multi-center, single arm, open label trial to evaluate the efficacy and safety of Cabozantinib (XL184) plus Pembrolizumab in recurrent, persistent and/or metastatic cervical cancer with PD-L1 tumor positivity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Cabozantinib 40 mg oral once a day
Pembrolizumab 200 mg IV every 3 weeks
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Progression Free Survival
Six months progression free survival as defined by RECIST v1.1 measured from signed written consent to the date of first documented tumor progression using RECIST v1.1, or death due to any cause or 24 months after the end of study treatment.
Time frame: Up to 24 months
Overall Response Rate
Overall response defined by Response Evaluation Criteria in Solid Tumors (RECIST v.1.1 criteria).
Time frame: Up to 24 months
Overall Survival
Overall survival will be defined as the time from signed written consent to the date of death or 24 months after the end of study treatment. A patient who has not died will be censored at the last known date of contact
Time frame: Up to 24 months
Incidence of Emergent Adverse Events
Evaluate the safety and tolerability measured by incidence of adverse events and serious adverse events, deaths, and laboratory abnormalities as measured by Common Terminology Criteria for Adverse Events v.4.0
Time frame: Up to 6 Months
Cervical Cancer Quality of Life
Quality of life as assessed by FACT Cx quality of life questionnaire. This frequency questionnaire is scaled from 0-4 with 0 being not at all and 4 being very much.
Time frame: Up to 6 Months
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