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

  • STATUS
    Recruiting
  • End date
    Dec 25, 2023
  • participants needed
    350
  • sponsor
    MelanomaPRO, Russia
Updated on 25 November 2021

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).

Details
Condition Advanced Melanoma
Clinical Study IdentifierNCT05120024
SponsorMelanomaPRO, Russia
Last Modified on25 November 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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