Title

Atezolizumab in patients with urinary tract squamous cell carcinoma: a single arm, open label, multicentre, phase II clinical trial.

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.

Outcomes

Primary Outcomes:

• To determine the clinical activity of atezolizumab in patients with incurable histologically confirmed, immunotherapy naïve UTSCC.
• Primary endpoint: Best overall objective response rate (ORR; the percentage with partial (PR) or complete (CR) response) by RECIST v1.1

Secondary Outcomes:

• To determine the safety and tolerability of atezolizumab in this clinical setting.
• To determine the overall survival (OS) of patients treated with atezolizumab in this clinical setting.
• To determine the progression-free survival (PFS) of patients treated with atezolizumab in this clinical setting.
• To determine the duration of response of patients treated with atezolizumab in this clinical setting.
• To determine efficacy by iRECIST as an alternative means of response assessment in this clinical setting.
• To determine tumour volume changes of individual patients treated with atezolizumab in this clinical setting.
• To determine the impact on quality of life of the atezolizumab in this clinical setting.
• To determine the impact of PD-L1 expression status on clinical response.

Trial Design

AURORA is a single arm, open label, multicentre, phase II clinical trial of atezolizumab immunotherapy, in immunotherapy naive patients with urinary tract squamous cell carcinoma (UTSCC).

Recruitment is intended to occur over approximately 2 years and will follow a two stage statistical design. However, the intention to allow continuous recruitment between Stage 1 and Stage 2.

Following a Screening Phase of up to 28 days, eligible patients will be registered and will then commence atezolizumab immunotherapy, every 28 days, within a Treatment Phase of up to 1 year. On treatment discontinuation, patients will be reviewed in an End of Treatment Visit, and then 12 weekly from the end of treatment until disease progression. Following disease progression, patients will revert to routine local follow up processes.

Trial Status:

Recruiting

Population:

33-36 patients aged ≥18 years with incurable histologically confirmed, immunotherapy naïve urinary tract squamous cell carcinoma.

 

This trial is funded by Cancer Research UK (award reference no. CRCPJT\100018)

Senior Trial Manager:

Sarah-Jane Bibby

Trial Coordinator:

Mary Danh

Trial Assistant:

Chloe Shergold

Statistician:

Megan Lawrence

Data Manager:

Zoe Konn

Clinical Data Coordinator:

Uroosha Ali Babul Hussain

Clinical Trial Monitor:

Oli Dewane

Contact Information for trial queries:

Email: [email protected]

Phone: 023 8120 5154

SAE Reporting:

Email: [email protected]

Simon Crabb, Robin Wickens, Sarah Jane-Bibby, et al. Evaluating atezolizumab in patients with urinary tract squamous cell carcinoma (AURORA): study protocol for a single arm, open-label, multicentre, phase II clinical trial. BMC Cancer, 2023. doi.10.1186/s12885-023-11397-x

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