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

NCT ID: NCT05120024

Last Updated: 2021-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-14

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Advanced Melanoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MelanomaPRO, Russia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristina Orlova, MD PhD

Role: STUDY_CHAIR

MelanomaPRO, Russia

Locations

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N.N. Blokhin National Medical Research Center of Oncology

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Kristina Orlova, MD, PhD

Role: CONTACT

Phone: +79629359242

Email: [email protected]

Facility Contacts

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Kristina Orlova, MD, PhD

Role: primary

Other Identifiers

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FORA

Identifier Type: -

Identifier Source: org_study_id