Evaluating atezolizumab in patients with urinary tract squamous cell carcinoma (AURORA): study protocol for a single arm, open-label, multicentre, phase II clinical trial

Table 1 Schedule of observations and procedures

Visit	Screening Phase	Treatment Phase^a			End of Treatment Visit	Follow Up Phase	Remote Survival Follow Up^b
Visit		Cycle 1 Day 1	Cycle 2 Day 1	Cycle 3 to 13 Day 1	28 days from final dose	12 weekly^c	As per local policy
Week	Day -28 to 1	1	5	9 +
Window			± 3 days	± 3 days	± 1 week	± 1 week
Informed consent^d	X
Inclusion/exclusion criteria	X
Medical history	X
Targeted physical exam	X	X	X	X	X	X
ECOG performance status	X	X	X	X	X	X
CT chest/abdomen/pelvis^e	X			X		X
Biochemistry^f	X		X	X	X
Haematology^g	X		X	X	X
Archival tumour material	X
Translational blood samples^h		X		X^h	X^h	X^h
Concomitant medications	X	X	X	X	X	X
Adverse event assessment		X	X	X	X	X
QOL questionnaireⁱ	X			Xⁱ		Xⁱ
Atezolizumab		X	X	X
Pregnancy Testing (WOCBP)	X^j	X	X	X
Patient survival status							X

^a28-day treatment cycle (± 3 days from last dose)
^b Follow up as per local policy
^c 12 weekly, until disease progression. Assessment points during the Follow Up Phase should be timed such that they continue seamlessly with the 12-weekly schedule of CT scans during the Treatment Phase
^d Consent may be taken up to 2 months prior to Cycle 1 Day 1
^e To include cross-sectional imaging of chest, abdomen and pelvis by CT scan during the screening period including response assessment by RECIST, and then every 12 weeks (± 1 week) from enrolment during the Treatment Phase and Follow Up phase until disease progression. (MRI is acceptable if local practice would substitute this, or in cases of renal impairment)
^f Serum biochemistry including renal, liver (including ALT, AST, ALP and bilirubin), bone (including serum albumin and calcium) and thyroid profiles, and random cortisol and glucose levels
^g Including Hb, WCC, neutrophil count, platelet count and differential
^h Translational blood sample for C1D1, C4D1 (12 weeks on treatment) and at disease progression only. Samples may be collected up to 1 week prior to IMP treatment
ⁱ Quality of life questionnaire (EORTC QLQ-C30) to be completed during screening and every 12 weeks to disease progression
^j Pregnancy test at Screening must be serum test. All pregnancy testing following this can be urine testing

ISSN: 1471-2407