Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587451
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Integrated Pharmacokinetics PKefficacy Safety and Immunogenicity Study to Demonstrate Similarity of JPB898 a Proposed Biosimilar to Nivolumab to Opdivo in Combination with Yervoy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Parallel-group Study to Compare Pharmacokinetics Efficacy Safety and Immunogenicity of JPB898 proposed Nivolumab Biosimilar and US-licensed and EU-authorized Opdivo in Combination with Yervoy in Participants with Untreated Advanced unresectablemetastatic Melanoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The purpose of the study is to demonstrate similar PK and efficacy and to show comparable safety and immunogenicity between JPB898 Opdivo-EU and Opdivo-US all administered in combination with Yervoy-EU induction phase only in participants with advanced unresectable Stage III or metastatic Stage IV melanoma
Detailed Description:
None
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