Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:48 PM
Study NCT ID:
NCT07414992
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Radiation Therapy and Cemiplimab With or Without Fianlimab In People With Bladder Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Study Overview
Official Title:
Neoadjuvant STereotActic Body Radiotherapy and Cemiplimab With or Without Fianlimab for Cisplatin-Ineligible or Cisplatin-Declining Patients With Muscle-Invasive Bladder Cancer (NeoSTAR Bladder)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
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 researchers are doing this study to find out whether stereotactic body radiation therapy (SBRT) in combination with immunotherapy (cemiplimab with or without fianlimab) before cystectomy is an effective and safe treatment for people with muscle-invasive bladder cancer (MIBC).
Detailed Description:
Patients will be assigned to neoadjuvant SBRT and cemiplimab (Cohort 1) until Cohort 1 completes accrual and then enrollment for Cohort 2 will begin with those patients receiving neoadjuvant SBRT plus cemiplimab and fianlimab.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?: