Atezolizumab Given in Combination With a Personalized Vaccine in Patients With Urothelial Cancer

Phase 1 Completed 10 enrolled Matthew Galsky Genentech, Inc. · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the good and bad effects of atezolizumab given in combination with a personalized cancer vaccine in patients with urothelial cancer either after surgery to remove organ where the tumor arose (for example, removal of the bladder) or for urothelial cancer that has spread to other organs.

Timeline

Start: 2019-05-08
Primary completion: 2021-10-12
Completion: 2021-10-12

Outcome

Met primary endpoint

paper Neoantigen vaccination plus ICI was feasible and safe, meeting its endpoints, and warrants further investigation. PMID 40346292 ↗

Publications

Saxena M, Anker JF, Kodysh J, O'Donnell T, Kaminska AM, Meseck M, Hapanowicz O, Niglio SA, Salazar AM, Shah HR, Kinoshita Y, Brody R, Rubinsteyn A, Sebra RP, Bhardwaj N, Galsky MD. Atezolizumab plus personalized neoantigen vaccination in urothelial cancer: a phase 1 trial. Nat Cancer. 2025 Jun;6(6):988-999. doi: 10.1038/s43018-025-00966-7. Epub 2025 May 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atezolizumab	Monoclonal antibody	1200 mg	Intravenous
Subject	PGV001	Vaccine	100 ug	—
Background	Hiltonol	Other / unclassified	1.4 mg	—