Multicenter Study of Safety and Efficacy of Prolgolimab in Patients With Advanced Melanoma in Routine Clinical Practice
NCT05120024 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 350
Last updated 2021-11-15
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.
Conditions
Sponsors & Collaborators
-
MelanomaPRO, Russia
lead OTHER
Principal Investigators
-
Kristina Orlova, MD PhD · MelanomaPRO, Russia
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-14
- Primary Completion
- 2022-12-31
- Completion
- 2023-12-31
Countries
- Russia
Study Locations
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