Last updated on April 2020

Combination Pembrolizumab Chemotherapy and Bevacizumab in Patients With Cervical Cancer

Brief description of study

The investigators propose to evaluate the efficacy of the combination of standard chemotherapy with bevacizumab with Pembrolizumab in women with recurrent, persistent, or metastatic cervical cancer.

Detailed Study Description

This is a single arm, open-label, phase II study to assess progression free survival in patients treated with pembrolizumab, chemotherapy, and bevacizumab for recurrent, persistent, or metastatic cervical cancer. Progression free survival will be assessed in patients treated with this combination.

Eligible patients will require tissue biopsy for diagnostic confirmation of metastatic disease, disease recurrence or persistence. Patients will be treated with 3 cycles of combination therapy. A cycle will consist of pembrolizumab at 200mg (IV), paclitaxel 175mg/m2 or 135mg/m2 (IV), cisplatin 50mg/m2 (or carboplatin AUC 5) and bevacizumab 15mg/kg , on day 1 every 21 days.

All subjects will be followed for a Safety Evaluation at approximately 30-days (+7 days) after the last dose of study treatment or before the initiation of a new anti-cancer treatment, whichever occurs first. Thereafter subjects will be followed every 3-months for up to 24 months from the treatment discontinuation for survival data only.

Clinical Study Identifier: NCT03367871

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University of Miami

Miami, FL United States
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