Clinical trialNCT03502785CompletedPhase 1/PHASE2Interventional

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

SponsorInovio PharmaceuticalsEnrollment35Urothelial Carcinoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is 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 is divided into two cohorts: Cohort A: Participants with locally advanced unresectable or metastatic/recurrent UCa, who have 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 are treatment naïve and ineligible for cisplatin-based chemotherapy. A safety run-in will be performed with up to six participants (safety analysis participants) from cohort A.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Jeffrey Skolnik, MD
Inovio Pharmaceuticals
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

11 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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
Columbia University, Herbert Irving Comprehensive Cancer Center
New York, New York, United States
New York University Langone Medical Center - Perlmutter 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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

AtezolizumabINO-5401INO-9012

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 24 May 2018
Primary completion: 9 May 2025
Completion: 9 May 2025
Last update posted: 10 Jul 2025
Registered enrollment: 35
Registry id: NCT03502785

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.