Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534983
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma MIUC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Phase II Double-Blind Multicenter Study Evaluating the Efficacy and Safety of Autogene Cevumeran Plus Nivolumab Versus Nivolumab as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma
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:
IMCODE004
Brief Summary:
The main purpose of the study is to evaluate the efficacy of adjuvant treatment with autogene cevumeran plus nivolumab compared with nivolumab in participants with high risk MIUC
In this study participants will be enrolled in a safety run-in phase to receive autogene cevumeran nivolumab This phase will be conducted to monitor and ensure the safety of study participants After all participants in the safety run-in have been enrolled to receive autogene cevumeran nivolumab further participants will be randomization in either autogene cevumeran nivolumab or the saline nivolumab arm
In this study participants will be enrolled in a safety run-in phase to receive autogene cevumeran nivolumab This phase will be conducted to monitor and ensure the safety of study participants After all participants in the safety run-in have been enrolled to receive autogene cevumeran nivolumab further participants will be randomization in either autogene cevumeran nivolumab or the saline nivolumab arm
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