NCT05120024

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

2.1 years

First QC Date

November 3, 2021

Last Update Submit

November 3, 2021

Conditions

Advanced Melanoma

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (2)

  • Progression free survival (PFS)

    3 years

  • Overall survival (OS)

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with advanced melanoma, who were treated by prolgolimab (anti-PD1) in routine clinical practice in Russian Federation

You may qualify if:

  • Histological confirmed melanoma Advanced stage (unresectable III or metastatic IV) Treated by at least one therapy line including prolgolimab in routine practice -

You may not qualify if:

  • \- Patient participation in any interventional clinical study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

N.N. Blokhin National Medical Research Center of Oncology

Moscow, 115478, Russia

RECRUITING

Study Officials

  • Kristina Orlova, MD PhD

    MelanomaPRO, Russia

    STUDY CHAIR

Central Study Contacts

Kristina Orlova, MD, PhD

CONTACT

+79629359242k.orlova@melanomapro.ru

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2021

First Posted

November 15, 2021

Study Start

October 14, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

November 15, 2021

Record last verified: 2021-11

Locations

RU(1)