AURORA: A single arm, multicentre, phase II clinical trial of atezolizumab immunotherapy for advanced squamous cell carcinoma of the bladder and urinary tract
Abstract
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Background:
Urinary tract squamous cell carcinoma (UTSCC) is a rare disease, comprising approximately 3% of histological subtypes from the bladder and urinary tract. Limited data exist to support treatment choices and no prospective trials, dedicated specifically to this histology, have been undertaken to evaluate immunotherapy. Prior data indicate high PD-L1 expression and tumour immune cell infiltration in a proportion of UTSCC cases. We report the Stage 1 outcome for the AURORA clinical trial, which tested atezolizumab immunotherapy for patients with incurable UTSCC.
Methods:
Patients had progressive, measurable, UTSCC and ECOG performance status 0-2. Mixed histology was permitted but with no urothelial carcinoma component. One prior line of systemic chemotherapy was permitted for advanced disease but no prior immunotherapy. Treatment comprised atezolizumab (1680 mg IV, q28d) until disease progression and for up to one year if tolerated. The primary endpoint was best overall objective response rate (ORR; RECIST v1.1) with a Simon 2 stage statistical design, and planned, independent, interim efficacy review after 19 patients were assessable for response (without a recruitment pause). If ≥4 of the first 19 patients (Stage 1) achieved an objective response (confirmed partial or complete response), then recruitment would continue through Stage 2, where ≥8 responses in 33 patients were required to indicate further investigation was warranted (p1 = 15%, p2 = 35%, 1-sided…
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