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)

Sponsor
Biocad
Study ID
NCT03912402
Phase
PHASE2
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

Study Details

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.

Key Dates

First listed
Apr 11, 2019
Start date
Dec 25, 2018
Status verified
May 2019
Primary completion
Jul 7, 2020
Completion
Jul 7, 2020

Study Design

Enrollment
49 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BCD-100
    BCD-100 mg/kg Q3W

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 6 months ]

Central Contacts

Related Studies