Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623162
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Sasanlimab As Maintenance Treatment Based on Clinical Response to Neoadjuvant Treatment in Molecularly Categorized Muscle Invasive Bladder Cancer Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Selective Bladder-Sparing Trial with Sasanlimab As Maintenance Treatment Based on Clinical Response to Neoadjuvant Treatment in Molecularly Categorized Muscle Invasive Bladder Cancer Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
SASAN-SPARING
Brief Summary:
Selective Bladder-Sparing Trial with Sasanlimab as Maintenance Treatment Based On Clinical Response To Neoadjuvant Treatment In Molecularly Categorized Muscle Invasive Bladder Cancer Patients
Detailed Description:
All patients will receive 4 cycles of gemcitabine plus cisplatin followed by clinical restaging Fig1 After neoadjuvant chemotherapy patients will be restaged and patients achieving a clinical response normal cytology imaging and cT0TaT1Tis will be eligible to proceed without cystectomy and receive maintenance with sasanlimab 300 mg subcutaneous two product presentations a vial and a prefilled syringe every 4 weeks Q4W for up to 12 cycles initiating between 3-6 weeks and followed by surveillance Fig1 Treatment may be discontinued in case of progression unacceptable toxicity patient withdrawal or death Patients with persistent non-muscle invasive disease cTaT1Tis at the first evaluation at 12 weeks of maintenance after 3 cycles of sasanlimab will be recommended to undergo cystectomy
Non clinically responding patients T2 after neoadjuvant chemotherapy will undergo cystectomy Fig1 Patients may undergo late cystectomy throughout the study period in the case of local relapse following the investigator criteria or according to the patient39s choice
Non clinically responding patients T2 after neoadjuvant chemotherapy will undergo cystectomy Fig1 Patients may undergo late cystectomy throughout the study period in the case of local relapse following the investigator criteria or according to the patient39s choice
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