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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Inovio Pharmaceuticals
Study ID
NCT03502785
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INO-5401 — BIOLOGICAL
    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 — BIOLOGICAL
    INO-9012: A synthetic plasmid that expresses human interleukin-12 (IL-12). IM injection.
  • Atezolizumab — DRUG
    IV-Infusion.
  • CELLECTRA® 2000 — DEVICE
    IM injection.

Study Details

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.

Key Dates

First listed
Apr 19, 2018
Start date
Jul 24, 2018
Status verified
Sep 2026
Primary completion
May 9, 2025
Completion
May 9, 2025

Study Design

Enrollment
35 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Prior Anti-PD-1/PD-L1
    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 cell death-ligand 1 (PD-1/PD-L1) therapy received INO-5401 9 milligrams (mg) and INO-9012 1 mg, intramuscular (IM) injection, followed by electroporation (EP) by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, intravenous (IV) infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.
  • Experimental: Cohort B: Naïve Anti-PD-1/PD-L1
    Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.

Primary Outcome Measure

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs) Treatment [ Time Frame: Up to approximately 71 months ]

Locations (11)

FacilityCityStateZIPSite coordinators
Mayo Clinic Cancer CenterPhoenixArizona85054-
H. Lee Moffitt Cancer Center & Research Institute, Inc.TampaFlorida33612-
Johns Hopkins University School of MedicineBaltimoreMaryland21287-
Karmanos Cancer InstituteDetroitMichigan48201-
Washington University School of Medicine in St. LouisSt LouisMissouri63110-
Columbia University, Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
New York University Langone Medical Center - Perlmutter Cancer CenterNew YorkNew York10016-
University of North Carolina School of MedicineChapel HillNorth Carolina27599-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
Greenville Memorial HospitalGreenvilleSouth Carolina29615-
Inova Melanoma and Skin Cancer CenterFairfaxVirginia22031-

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