NCT05120024

Multicenter Study of Safety and Efficacy of Prolgolimab in Patients With Advanced Melanoma in Routine Clinical Practice

Multicenter Non-interventional Retro- and Prospective Safety and Efficacy Study of Prolgolimab (Forteca - Anti-PD1) in Patients With Advanced Melanoma (FOrteca Real Practice Assessment)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: MelanomaPRO, Russia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Describe the safety, tolerability, efficacy and approaches to prescribing prolgolimab in the standard dosing regimen of 1 mg / kg every 2 weeks in patients with advanced melanoma in routine practice. Prolgolimab (Forteca, formerly BCD 100) is an IgG1 anti-PD-1 (programmed cell death protein 1) monoclonal antibody containing the Fc-silencing 'LALA' mutation.

Detailed description

Describe the safety and tolerability of using Prolgolimab at a standard dosage regimen of 1 mg / kg every 2 weeks. Describe the efficacy of prolgolimab 1 mg / kg every 2 weeks in patients with metastatic or inoperable melanoma in routine practice, based on the following indicators: Progression-free survival (time from first dose of prolgolimab to disease progression or death for any reason); Overall survival (time from receiving the first dose of prolgolimab to death for any reason); Objective response rate (proportion of patients with a complete or partial response to prolgolimab therapy).

Conditions

• Advanced Melanoma

Timeline

• Start date: 2020-10-14
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2021-11-15
• Last updated: 2021-11-15

Locations

1 site across 1 country: Russia