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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 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2019-05-09

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

BCD-100

Anti-PD-1 monoclonal antibody, IV infusion

BIOLOGICAL

Bevacizumab

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Cisplatin (or carboplatin)

IV infusion

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Roman A Ivanov, PhD · Vice President R&D, JSC BIOCAD

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03912402 on ClinicalTrials.gov