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INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma
Sponsor: Inovio Pharmaceuticals
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
Conditions
Interventions
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
INO-9012
INO-9012: A synthetic plasmid that expresses human interleukin-12 (IL-12). IM injection.
Atezolizumab
IV-Infusion.
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