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

NCT03359239 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-05-16

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Matthew Galsky

    lead OTHER

Principal Investigators

  • Matthew Galsky, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-08
Primary Completion
2021-10-12
Completion
2021-10-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03359239 on ClinicalTrials.gov