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

Conditions

• Urothelial/Bladder Cancer, Nos

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  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.
• PGV001 — BIOLOGICAL
  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)
• Poly ICLC — DRUG
  1.4 mg (0.7 mL, 2 mg/mL)
• Normal saline — DRUG
  0.19 mL

Study Details

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.

Key Dates

Start date

May 8, 2019

Status verified

May 2023

Primary completion

Oct 12, 2021

Completion

Oct 12, 2021

Study Design

Enrollment

10 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: PGV 001 with Atezolizumab
  Atezolizumab: programmed death-ligand 1 PGV001:personalized cancer vaccine PGV 001 - vaccine Poly ICLC- adjuvant The product is prepared within the Icahn School of Medicine at Mount Sinai (ISMMS) . The product consists of two independent preparations of patient specific long peptides mixed with poly-ICLC.

Primary Outcome Measure

Number of neoantigens [ Time Frame: up to 24 months ]

Locations (1)

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