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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.
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).
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Objective response rate | The response rate during prolgolimab therapy in patients with unresectable advanced melanoma | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | The median PFS and 24 months PFS rate of patients with advanced melanoma during prolgolimab | 3 years |
| Overall survival (OS) | The median OS and 24 months OS rate of patients with advanced melanoma |
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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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Patients with advanced melanoma, who were treated by prolgolimab (anti-PD1) in routine clinical practice in Russian Federation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristina Orlova, MD, PhD | Contact | +79629359242 | k.orlova@melanomapro.ru |
| Name | Affiliation | Role |
|---|---|---|
| Kristina Orlova, MD PhD | MelanomaPRO, Russia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| N.N. Blokhin National Medical Research Center of Oncology | Recruiting | Moscow | 115478 | Russia |
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| 3 years |