NCT05038657

Atezolizumab Immunotherapy, in Immunotherapy Naive Patients With Urinary Tract Squamous Cell Carcinoma (UTSCC).

Atezolizumab in Patients With Urinary Tract Squamous Cell Carcinoma: a Single Arm, Open Label, Multicentre, Phase II Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University Hospital Southampton NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Squamous Cell Carcinoma
• Urinary Tract Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab	Treatment will consist of atezolizumab, by IV infusion, at a fixed dose of 1680 mg, every 28 days (day 1 of each cycle, +/- 3 days), for up to one year. Each participant will receive up to 13 doses in total.

Timeline

• Start date: 2022-05-30
• Primary completion: 2024-01-01
• Completion: 2025-01-01
• First posted: 2021-09-09
• Last updated: 2022-10-03

Locations

1 site across 1 country: United Kingdom