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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)

NCT03912415 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2020-09-18

No results posted yet for this study

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

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

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Yulia N Linkova, MD, PhD · Director of Clinical Development Department, BIOCAD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2024-12-01
Completion
2024-12-01

Countries

  • China
  • Georgia
  • Russia
  • Turkey (Türkiye)

Study Locations

More Related Trials

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 NCT03912415 on ClinicalTrials.gov