NCT03912415

Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy With and Without Bevacizumab as First-Line Treatment of Subjects With Advanced Cervical Cancer (FERMATA)

An International Randomized Double-blind Clinical Trial of BCD-100 Plus Platinum-based Chemotherapy With and Without Bevacizumab Versus Placebo Plus Platinum-based Chemotherapy With and Without Bevacizumab as First-Line Treatment of Subjects With Advanced Cervical Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 316 (estimated)
• Sponsor: Biocad · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
BIOLOGICAL	BCD-100	Anti-PD-1 monoclonal antibody, IV infusion
BIOLOGICAL	Bevacizumab	IV infusion
DRUG	Paclitaxel	IV infusion
DRUG	Cisplatin (or Carboplatin)	IV infusion
OTHER	Placebo	Placebo

Timeline

• Start date: 2019-10-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2019-04-11
• Last updated: 2020-09-18

Locations

26 sites across 4 countries: China, Georgia, Russia, Turkey (Türkiye)