NCT05783882

Prolgolimab 250 mg Q3W in Patients With Unresectable or Metastatic Melanoma

Multicenter Open-label Study of the Efficacy, Pharmacokinetica and Safety of Prolgolimab 250 mg Q3W in Patients With Unresectable or Metastatic Melanoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Prolgolimab	250 mg Q3W

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2023-03-24
• Last updated: 2023-03-24

Locations

6 sites across 1 country: Russia