Study of Atezolizumab Combined With Split-dose Gemcitabine Plus Cisplatin in Urothelial Carcinoma
Status:
Recruiting
Trial end date:
2024-01-01
Target enrollment:
Participant gender:
Summary
Phase II, multicenter, non-randomized, single-arm, open-label trial of atezolizumab in
combination of split-doses of gemcitabine plus cisplatin in patients with locally advanced or
metastatic urothelial carcinoma.
The Aurea trial aims to evaluate the preliminary efficacy of atezolizumab plus split-dose
gemcitabine and cisplatin (GC) for the first-line setting, in patients with histologically
confirmed advanced (locally advanced and metastatic) urothelial cancer in terms of overall
response rate (ORR) assessed by the investigator using the Response Evaluation Criteria in
Solid Tumors (RECIST) v1.1.
Secondary objectives include: efficacy (clinical benefit rate, duration of response, time to
response, overall survival and progression-free survival); safety (frequency and severity of
adverse events assessed by NCI CTCAE v5.0) and exploratory endpoints ( correlation of
prognostic biomarkers/factors with efficacy and relationship between the expression of PD-L1
and microbiome with ORR and PFS).
At least 66 patients will be included.
The treatment schedule is as follows:
Atezolizumab at a fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each 21-day
cycle up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin
70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8)
for up to 6 cycles.