Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT05732805
Brief Summary:
The aim of study is to investigate the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of BCD-217 followed by prolgolimab monotherapy versus prolgolimab monotherapy as first-line therapy in subjects with unresectable or metastatic melanoma.
Detailed Description:
This study is designed as a phase III, randomized, double-blind, placebo-controlled study.
After the stratification procedure, subjects are randomized in a 1:1 ratio into 2 groups:
* BCD-217 + placebo (4 doses) → prolgolimab (BCD-217 group)
* Prolgolimab + placebo (4 doses) → prolgolimab (BCD-100 monotherapy group)
Study:
NCT05732805
Study Brief:
Protocol Section:
NCT05732805