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Clinical Trial Summary

This is a randomized, multicenter, double-blind, Phase 3 study of efficacy and safety of BCD-100 plus platinum-based chemotherapy with and without bevacizumab versus placebo plus platinum-based chemotherapy with and without bevacizumab


Clinical Trial Description

Subjects will be randomized in a 1:1 ratio to receive either Test Regimen or Comparator Regimen as the first-line treatment for advanced cervical cancer. Subjects will receive study therapy Q3W until progression of the disease or signs of unacceptable toxicity. In the absence of dose-limiting toxicity chemotherapy should be continued for at least 6 cycles, then, upon Investigator's decision and/or subjects' wish, the use of chemotherapy can be stopped while maintenance therapy with BCD-100/Placebo with or without bevacizumab (depending on initial therapy choice) continues until disease progression. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03912415
Study type Interventional
Source Biocad
Contact Sergey N Fogt, MD, PhD
Phone +7-(812)-380-49-33
Email biocad@biocad.ru
Status Recruiting
Phase Phase 3
Start date October 1, 2019
Completion date December 1, 2024

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