Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06009848
Status:
RECRUITING
Last Update Posted:
2023-08-24
First Post:
2023-08-19
Brief Title:
Cadonilimab Plus Nab-Paclitaxel for Recurrent or Metastatic Muscle Invasive Bladder Cancer
Sponsor:
Tianjin Medical University Second Hospital
Organization:
Tianjin Medical University Second Hospital
Study Overview
Official Title:
An Open Single Arm Prospective Phase II Clinical Study on the First-line Treatment of Recurrent or Metastatic Muscle Invasive Bladder Cancer With CadonilimabAK104 Plus Nab-Paclitaxel
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the efficacy and safety of CadonilimabAK104 combined with Nab -Paclitaxel as first line therapy for recurrent or metastatic muscle invasive bladder Eligible participants will receive AK104 up to 24 months plus Nab-Paclitaxel for 6 cycles until radiologic disease progression unacceptable toxicity or withdrawal from the study whichever occurred first The primary endpoint is objective response rate
Detailed Description:
CadonilimabAK104 is a first-in-class bispecific humanized IgG1 antibody targeting PD-1 and CTLA-4 which has the potential to boost immune surveillance in tumors The goal of this clinical phase II trial is to evaluate the efficacy and safety of AK104 combined with Nab-Paclitaxel as first line therapy for recurrent or metastatic muscle invasive bladder
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None