NCT03359239

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

Pilot Study of Atezolizumab Plus PGV001, a Multipeptide Personalized Neoantigen Vaccine, in Patients With Locally Advanced or Metad or Metastatic Urothelial Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Matthew Galsky · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single arm, proof-of-concept study. Fifteen subjects with urothelial cancer interested in participation will sign a "tissue acquisition and vaccine preparation consent" after which tumor tissue will be obtained from either a surgical resection specimen or biopsy. Subjects are scheduled to undergo cystectomy or nephroureterectomy for invasive urothelial cancer may consent prior to, or within 6 weeks after, surgery. The tumor specimen will be submitted for genomic sequencing followed by neoantigen identification utilizing a computational pipeline. Peptides corresponding to these neoantigens will be prepared for the personalized vaccine product. Subjects eligible for the treatment phase of the protocol (i.e., after surgery in adjuvant patients and chemotherapy in metastatic patients) will receive atezolizumab every 3 weeks plus up to ten doses of PGV001 vaccination plus Poly-ICLC. The primary objectives will be to determine the feasibility and safety of administration of a personalized neoantigen-based vaccine (PGV001) plus atezolizumab in subjects with locally advanced or metastatic urothelial cancer.

Conditions

• Urothelial/Bladder Cancer, Nos

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-05-08
• Primary completion: 2021-10-12
• Completion: 2021-10-12
• First posted: 2017-12-02
• Last updated: 2023-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study