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)

Sponsor
Biocad
Study ID
NCT03912415
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Apr 11, 2019
Start date
Oct 1, 2019
Status verified
Sep 2020
Primary completion
Dec 1, 2024
Completion
Dec 1, 2024

Study Design

Enrollment
316 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BCD-100
    BCD-100 3 mg/kg Q3W
  • Placebo Comparator: Placebo

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: 3 years ]

Central Contacts

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