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

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

May 8, 2019

Primary Completion Date

October 12, 2021

Study Completion Date

October 12, 2021

Conditions
Urothelial/Bladder Cancer, Nos
Interventions
DRUG

Atezolizumab

1200 mg administered by IV infusion every 3 weeks (21 \[+/-2\] days) for up to 12 months in the adjuvant setting and up to 24 months in the metastatic setting.

BIOLOGICAL

PGV001

"PGV001: up to ten total doses of PGV001with helper peptides. The product is prepared within the ISMMS . The product consists of two independent preparations of patient specific long peptides mixed with poly-ICLC.~A dose of PGV001 consists of the following:~Up to ten synthetic peptides - 100μg (0.01 mL, 10 mg/mL) per peptide. One tetanus helper peptide - 100μg (0.01 mL, 10 mg/mL)"

DRUG

Poly ICLC

1.4 mg (0.7 mL, 2 mg/mL)

DRUG

Normal saline

0.19 mL

Trial Locations (1)

10029

Icahn School of Medicine at Mount Sinai, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

Matthew Galsky

OTHER