A Phase II Study of Atezolizumab in Combination With Cisplatin + Gemcitabine Before Surgery to Remove the Bladder Cancer

Summary

The purpose of this study is to test the safety of the study drug, atezolizumab, when combined with the standard chemotherapy drugs, gemcitabine and cisplatin (or GC). This study will help researchers begin to understand whether combining GC with atezolizumab is better, the same, or worse than the usual approach of using GC alone.

Timeline

Start

2016-12-20

Primary completion

2026-12

Completion

2026-12

Outcome

Met primary endpoint

paper The primary end point was met, with 27 of 39 patients (69%) < pT2N0 PMID 35089812 ↗

Publications

• Funt SA, Lattanzi M, Whiting K, Al-Ahmadie H, Quinlan C, Teo MY, Lee CH, Aggen D, Zimmerman D, McHugh D, Apollo A, Durdin TD, Truong H, Kamradt J, Khalil M, Lash B, Ostrovnaya I, McCoy AS, Hettich G, Regazzi A, Jihad M, Ratna N, Boswell A, Francese K, Yang Y, Folefac E, Herr HW, Donat SM, Pietzak E, Cha EK, Donahue TF, Goh AC, Huang WC, Bajorin DF, Iyer G, Bochner BH, Balar AV, Mortazavi A, Rosenberg JE. Neoadjuvant Atezolizumab With Gemcitabine and Cisplatin in Patients With Muscle-Invasive Bladder Cancer: A Multicenter, Single-Arm, Phase II Trial. J Clin Oncol. 2022 Apr 20;40(12):1312-1322. doi: 10.1200/JCO.21.01485. Epub 2022 Jan 28.

Drugs

Indications