Prolgolimab 250 mg Q3W in Patients With Unresectable or Metastatic Melanoma
Status:
Active, not recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
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.