NCT03912402

Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy and Bevacizumab in Patients With Recurrent, Persistent or Metastatic Cervical Cancer (CAESURA)

Multicenter Open-Label Single-Arm Trial of the Efficacy and Safety of BCD-100 in Combination With Platinum-Based Chemotherapy and Bevacizumab as First Line Treatment in Patients With Recurrent, Persistent or Metastatic Cervical Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Biocad · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cervical Cancer
• Cervical Cancer Metastatic
• Cervical Cancer Recurrent

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

Timeline

• Start date: 2018-12-25
• Primary completion: 2020-07-07
• Completion: 2020-07-07
• First posted: 2019-04-11
• Last updated: 2019-05-09

Locations

24 sites across 1 country: Russia