ClinicalTrials.gov posted results on 2 September 2026 for a completed Phase 1/Phase 2 trial of atezolizumab combined with INO-5401 and INO-9012 in urothelial carcinoma. The study enrolled 35 participants; investigator-assessed objective response rate was 40% in participants who had not previously received anti-PD-1 or anti-PD-L1 treatment, compared with 0% in those with prior exposure.

Background

The trial evaluated atezolizumab with INO-5401 and INO-9012 in participants with locally advanced unresectable or metastatic/recurrent urothelial carcinoma. The registry described the study’s purpose as evaluating safety, immunogenicity, and preliminary clinical efficacy. The listed interventions were INO-5401, INO-9012, and atezolizumab.

Trial design

NCT03502785 was an open-label, multicenter Phase 1/Phase 2 study listed as completed, with 35 participants enrolled. The combination of INO-5401 and INO-9012 was delivered by intramuscular injection followed by electroporation, in combination with atezolizumab.

The trial included two cohorts: Cohort A comprised participants with locally advanced unresectable or metastatic/recurrent urothelial carcinoma whose disease had progressed during or after anti-PD-1 or anti-PD-L1 treatment; Cohort B comprised participants who had not previously received anti-PD-1 or anti-PD-L1 treatment. The supplied record contained no primary outcome entries or statistical analyses.

Key results

The posted measurements included participant counts for treatment-emergent adverse events and adverse events of special interest. Cohort A included 27 participants, while Cohort B included 8 participants. A second measurement under the same outcome listed 2 participants in Cohort A and 0 participants in Cohort B; the supplied data did not identify the distinction between these two entries.

  • Clinically significant changes in hematological parameters were reported for 0 participants in Cohort A and 0 participants in Cohort B.
  • Clinically significant changes in serum chemistry parameters were reported for 0 participants in Cohort A and 0 participants in Cohort B.
  • Clinically significant changes in urinalysis parameters were reported for 0 participants in Cohort A and 0 participants in Cohort B.
  • Investigator-assessed ORR by RECIST version 1.1 was 0% in Cohort A and 40% in Cohort B.

What this means

The registry results show a directional difference in reported response rate between participants with prior anti-PD-1 or anti-PD-L1 treatment and those without such prior treatment. The available measurements also reported no participants with clinically significant hematological, serum chemistry, or urinalysis changes in either cohort.

The data block does not provide p-values, confidence intervals, response counts, duration of response, a detailed adverse-event summary, or comparative statistical analyses. These results therefore describe the posted trial measurements but do not establish comparative efficacy or change atezolizumab’s approved use.

Source

Source: ClinicalTrials.gov, registry record for “INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma,” NCT03502785, with results posted on 2 September 2026. The record is available at clinicaltrials.gov/study/NCT03502785.