Ignite Creation Date:
2025-12-24 @ 6:57 PM
Ignite Modification Date:
2025-12-28 @ 3:24 PM
Study NCT ID:
NCT05038657
Status:
UNKNOWN
Last Update Posted:
2022-10-03
First Post:
2021-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atezolizumab Immunotherapy, in Immunotherapy Naive Patients With Urinary Tract Squamous Cell Carcinoma (UTSCC).
Sponsor:
University Hospital Southampton NHS Foundation Trust
Organization:
Study Overview
Official Title:
Atezolizumab in Patients With Urinary Tract Squamous Cell Carcinoma: a Single Arm, Open Label, Multicentre, Phase II Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
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:
AURORA
Brief Summary:
Atezolizumab in patients with urinary tract squamous cell carcinoma: a single-arm, open-label, multicentre, phase II clinical trial
Detailed Description:
AURORA is a phase II open-label trial of Atezolizumab in patients with urinary tract squamous cell carcinoma (UTSCC). UTSCC is the most common of the rare urinary tract cancer histologies, comprising 2.1-6.7% of urinary tract cancers overall. There are few data available to guide treatment decisions for UTSCC. The AURORA trial will test the hypothesis that PD-L1 inhibition with atezolizumab immunotherapy is clinically effective, tolerable and safe, in patients with urinary tract squamous cell carcinoma (UTSCC). Translational endpoints will aim to determine characteristics for responsiveness to this treatment. AURORA was developed on behalf of the International Rare Cancers Initiative (IRCI) and the National Cancer Research Institute Bladder and Renal Group.
Study Oversight
Has Oversight DMC:
True
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?: