Melanoma Clinical Trial
Official title:
An International Multicenter Open-label Randomized Trial of the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) as Monotherapy in Patients With Unresectable/Metastatic Melanoma.
An International Multicenter Open-label Randomized Trial of the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) as Monotherapy in Patients with Unresectable/Metastatic Melanoma.
This trial has been designed as an international multicenter open-label Phase II trial.
The trial aims to investigate the efficacy, pharmacokinetics, safety, and immunogenicity of
two dosage regimens of BCD-100 (JSC BIOCAD, Russia) as monotherapy in patients with
unresectable/metastatic melanoma.
According to the design, the trial will include two arms of patients. Each of the trial arms
will receive repeated doses of the test drug as monotherapy; BCD-100 will be administered
using one of the following dosage regimens established in a Phase I trial:
- Monotherapy, BCD-100 1 mg/kg Q2W (IV infusion over 60 minutes; if a 60-minute infusion
is tolerated well, all following doses can be administered over 30 minutes);
- Monotherapy, BCD-100 3 mg/kg Q3W (IV infusion over 60 minutes; if a 60-minute infusion
is tolerated well, all following doses can be administered over 30 minutes).
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