MedTrace Logo

Prolgolimab 250 mg Q3W in Patients With Unresectable or Metastatic Melanoma

NCT05783882 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2023-03-24

No results posted yet for this study

Summary

Multicentre, single-arm, open-label efficacy, pharmacokinetics, and safety study to demonstrate non-inferiority of prolgolimab 250 mg every 3 weeks versus historical data for prolgolimab 1 mg/kg every 2 weeks in patients with unresectable or metastatic melanoma, as well as collecting pharmacokinetics and safety data.

The study is conducted under the same conditions as the previously conducted study BCD-100-2/MIRACULUM. This means that this Study No. BCD-100-8/FLAT has identical parameters such as:

* selection criteria for subjects in the study, defining the population,
* research centers,
* procedures for evaluating effectiveness and safety,
* permitted prior and concomitant therapy of the underlying disease.

Conditions

  • Unresectable or Metastatic Melanoma

Interventions

DRUG

Prolgolimab

250 mg Q3W

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • Russia

Study Locations

More Related Trials

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 NCT05783882 on ClinicalTrials.gov