drugset / Trial / 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)

NCT03912402

Phase 2 Unknown 49 enrolled Biocad
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-12-25
Primary completion
2020-07-07
Completion
2020-07-07

Drugs

EvaluationDrugModalityDoseRoute
Subject BCD-100 Monoclonal antibody Intravenous
Background Bevacizumab Monoclonal antibody Intravenous
Background Carboplatin Small molecule Intravenous
Background Cisplatin Other / unclassified Intravenous
Background Paclitaxel Small molecule Intravenous

Indications