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Clinical Trial Summary

This is a multicenter, open-label, single-arm study of efficacy, safety and pharmacokinetics of BCD-100 (JSC BIOCAD, Russia) in combination with platinum-based chemotherapy and bevacizumab as first-line treatment in patients with recurrent/persistent or metastatic cervical cancer.


Clinical Trial Description

The study will be conducted in two stages. At the first stage patients will receive up to 6 cycles of BCD-100 in combination with platinum-based chemotherapy and bevacizumab or until unacceptable toxicity or disease progression. Patients who have demonstrated a positive antitumor effect (stabilization of the disease, partial or complete response) and who have no signs of unacceptable toxicity could continue to receive up to 12 cycles of maintenance therapy of BCD-100 in combination with bevacizumab or until unacceptable toxicity or disease progression. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03912402
Study type Interventional
Source Biocad
Contact Mariia S Shustova, MD
Phone +7-(812)-380-49-33
Email biocad@biocad.ru
Status Recruiting
Phase Phase 2
Start date December 25, 2018
Completion date July 7, 2020

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