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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05120024

Acronym

FORA

Enrollment

350

Registered

2021-11-15

Start date

2020-10-14

Completion date

2023-12-31

Last updated

2021-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Melanoma

Brief 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).

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Histological confirmed melanoma Advanced stage (unresectable III or metastatic IV) Treated by at least one therapy line including prolgolimab in routine practice -

Exclusion criteria

\- Patient participation in any interventional clinical study.

Design outcomes

Primary

Measure	Time frame	Description
The incidence of adverse events during prolgolimab therapy	2 years	The rate of all grade and grade 3-5 adverse events and the rate of discontinuation of study drug(s) due to adverse events.
Objective response rate	3 years	The response rate during prolgolimab therapy in patients with unresectable advanced melanoma

Secondary

Measure	Time frame	Description
Progression free survival (PFS)	3 years	The median PFS and 24 months PFS rate of patients with advanced melanoma during prolgolimab
Overall survival (OS)	3 years	The median OS and 24 months OS rate of patients with advanced melanoma

Countries

Russia

Contacts

Primary ContactKristina Orlova, MD, PhD

k.orlova@melanomapro.ru+79629359242

Outcome results