Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640530
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo As Monotherapy in Subjects with Advanced Melanoma of the Skin
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Double-Blind Randomized Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo As Monotherapy in Subjects with Advanced Melanoma of the Skin
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UNIVERSE
Brief Summary:
The aim of the study BCD-263-2UNIVERSE is to demonstrate comparable efficacy and similar safety and immunogenicity profile of BCD-263 and Opdivo after repeated intravenous doses in subjects with advanced unresectable or metastatic melanoma of the skin
Detailed Description:
Following screening subjects will be randomized to receive either BCD-263 or Opdivo in a 11 ratio and enter the main study period
During the main study period subjects will receive therapy with BCD-263 or Opdivo which will be administered intravenously until disease progression or signs of unacceptable toxicity develop whichever occurs earlier
At Week 25 after completion of all scheduled procedures subjects in both groups will continue to receive open-label BCD-263 for up to a total of 2 years of therapy or disease progression or signs of unacceptable toxicity whichever occurs first
Following discontinuation of the study therapy the subjects will enter a follow-up period during which data on overall survival will be collected through telephone contacts
During the main study period subjects will receive therapy with BCD-263 or Opdivo which will be administered intravenously until disease progression or signs of unacceptable toxicity develop whichever occurs earlier
At Week 25 after completion of all scheduled procedures subjects in both groups will continue to receive open-label BCD-263 for up to a total of 2 years of therapy or disease progression or signs of unacceptable toxicity whichever occurs first
Following discontinuation of the study therapy the subjects will enter a follow-up period during which data on overall survival will be collected through telephone contacts
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None