NCT03913923

Study of Efficacy and Safety of BCD-217 (Anti-CTLA-4 and Anti-PD-1) Followed By BCD-100 (Anti-PD-1) Versus BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma

International Multicenter Double-Blind Placebo-Controlled Comparative Randomized Trial of Efficacy and Safety of BCD-217 (Anti-CTLA-4 and Anti-PD-1) And BCD-100 (Anti-PD-1) Therapy Compared to BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter randomized double-blind placebo-controlled phase II clinical trial. The purpose of this trial is to evaluate efficacy and safety of therapy consisting of BCD-217 (fixed dose combination of anti-CTLA-4 and anti-PD-1 monoclonal antibodies) and sequential BCD-100 (anti-PD-1 monoclonal antibody) versus BCD-100 monotherapy as first-line treatment in patients with treatment-naïve unresectable or metastatic melanoma.

Conditions

• Melanoma
• Melanoma Metastatic

Interventions

Type	Name	Description
BIOLOGICAL	BCD-217	Combination of anti-CTLA-4 and anti-PD-1 monoclonal antibodies, 1mg/kg and 3 mg/mg, respectively, given Q3W as IV infusion for first 4 blinded infusions
BIOLOGICAL	BCD-100	Anti-PD-1 monoclonal antibody, 3 mg/kg, given Q3W as IV infusion for first 4 blinded infusions, after - 1 mg/kg, given Q2W as IV infusion
OTHER	Placebo	Placebo

Timeline

• Start date: 2019-07-01
• Primary completion: 2023-07-01
• Completion: 2023-12-01
• First posted: 2019-04-12
• Last updated: 2023-02-10

Locations

23 sites across 2 countries: Belarus, Russia