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

Advanced Melanoma Clinical Trial

— FORA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05120024
• Other study ID #: FORA
• Status: Recruiting
• Start date: October 14, 2020
• Est. completion date: December 2023

Study information

• Verified date: November 2021
• Source: MelanomaPRO, Russia
• Contact: Kristina Orlova, MD, PhD
• Phone: +79629359242
• Email: k.orlova[@]melanomapro.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Melanoma
• Melanoma

Locations

Country	Name	City	State
Russian Federation	N.N. Blokhin National Medical Research Center of Oncology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
MelanomaPRO, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of adverse events during prolgolimab therapy	The rate of all grade and grade 3-5 adverse events and the rate of discontinuation of study drug(s) due to adverse events.	2 years
Primary	Objective response rate	The response rate during prolgolimab therapy in patients with unresectable advanced melanoma	3 years
Secondary	Progression free survival (PFS)	The median PFS and 24 months PFS rate of patients with advanced melanoma during prolgolimab	3 years
Secondary	Overall survival (OS)	The median OS and 24 months OS rate of patients with advanced melanoma	3 years