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 (9 milligram \[mg\] dose IM): 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.
  • INO-9012 — BIOLOGICAL
    INO-9012 (1 mg dose IM): A synthetic plasmid that expresses human interleukin-12 (IL-12). INO-5401 + INO-9012 will be administered IM followed by EP with CELLECTRA™ 2000 device every 3 weeks for 4 doses then every 6 weeks for 6 additional doses, thereafter every 12 weeks until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.
  • Atezolizumab — DRUG
    Atezolizumab will be administered by intravenous (IV) infusion every 3 weeks until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.
  • CELLECTRA™ 2000 — DEVICE
    IM injection of INO-5401 and INO-9012 is followed by EP with the CELLECTRA™ 2000 device.

Study Details

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.

Key Dates

Start date
May 24, 2018
Status verified
Jul 2025
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
    Participants with locally advanced unresectable or metastatic/recurrent UCa, who have confirmed disease progression during or following treatment with an anti-PD-1/PD-L1 therapy. Cohort A participants will be treated with INO-5401 and INO-9012 in combination with atezolizumab.
  • Experimental: Cohort B
    Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy. Cohort B participants will be treated with INO-5401 and INO-9012 in combination with atezolizumab.

Primary Outcome Measure

Number of Adverse Events [ Time Frame: From baseline up to 90 days after last dose of study medication (up to approximately 2 years and 3 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-

Find similar trials in Phoenix, AZ

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Mayo Clinic Cancer Center· Phoenix, AZH. Lee Moffitt Cancer Center & Research Institute, Inc.· Tampa, FLJohns Hopkins University School of Medicine· Baltimore, MDKarmanos Cancer Institute· Detroit, MIWashington University School of Medicine in St. Louis· St Louis, MOColumbia University, Herbert Irving Comprehensive Cancer Center· New York, NY

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