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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05120024 on ClinicalTrials.gov