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COMPLETED
NCT03502785
PHASE1/PHASE2

INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma

Sponsor: Inovio Pharmaceuticals

View on ClinicalTrials.gov

Summary

This was a Phase I/IIA, open-label, multi-center trial to evaluate the safety, immunogenicity and preliminary clinical efficacy of INO-5401 + INO-9012 delivered by intramuscular (IM) injection followed by electroporation (EP), in combination with atezolizumab in participants with locally advanced unresectable or metastatic/recurrent Urothelial Carcinoma (UCa). The trial population was divided into two cohorts: Cohort A: participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti-programmed death receptor-1/programmed death receptor ligand-1 (anti-PD-1/PD-L1) therapy; Cohort B: participants with locally advanced unresectable or metastatic/recurrent UCa, who were treatment naïve and ineligible for cisplatin-based chemotherapy. A safety run-in was performed using a modified rolling six design, enrolling up to 6 participants (safety analysis participants) from Cohort A.

Official title: An Open-Label, Multi-Center Trial of INO-5401 + INO-9012 in Combination With Atezolizumab in Subjects With Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2018-07-24

Completion Date

2025-05-09

Last Updated

2026-09-02

Healthy Volunteers

No

Interventions

BIOLOGICAL

INO-5401

INO-5401: A mixture of 3 synthetic plasmids that target Wilms' tumor gene-1 (WT1) antigen, prostate-specific membrane antigen (PSMA) and human telomerase reverse transcriptase (hTERT) antigen. IM injection

BIOLOGICAL

INO-9012

INO-9012: A synthetic plasmid that expresses human interleukin-12 (IL-12). IM injection.

DRUG

Atezolizumab

IV-Infusion.

DEVICE

CELLECTRA® 2000

IM injection.

Locations (11)

Mayo Clinic Cancer Center

Phoenix, Arizona, United States

H. Lee Moffitt Cancer Center & Research Institute, Inc.

Tampa, Florida, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

New York University Langone Medical Center - Perlmutter Cancer Center

New York, New York, United States

Columbia University, Herbert Irving Comprehensive Cancer Center

New York, New York, United States

University of North Carolina School of Medicine

Chapel Hill, North Carolina, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Greenville Memorial Hospital

Greenville, South Carolina, United States

Inova Melanoma and Skin Cancer Center

Fairfax, Virginia, United States