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NCT03502785 · ClinicalTrials.gov registry record · Phase 1
INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma
A Phase 1 study, sponsored by Inovio Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT03502785: Completed Phase 1 study, sponsored by Inovio Pharmaceuticals.
NCT03502785 is a Phase 1 study that has completed, run by Inovio Pharmaceuticals. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03502785, a Phase 1 study, has completed, sponsored by Inovio Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
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.
Primary Outcome
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as any AEs that occurred on or after Day 0. AESIs were toxicities and immune-mediated AEs that may have occurred up to 90 days after the last dose of trial treatment. AESIs were reported by the investigator to the Sponsor within 24 h
Interventions
- DRUG Atezolizumab
- BIOLOGICAL INO-5401
- BIOLOGICAL INO-9012
- DEVICE CELLECTRA™ 2000
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2018-05-24 |
| Est. Completion | 2025-05-09 |
| Phase | Phase 1 |
What the finished NCT03502785 record still lists
NCT03502785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 4 interventions - of which Atezolizumab is the first listed.
NCT03502785 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03502785 about?
NCT03502785 is a clinical study titled "INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma". 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 unr...
What is the current status of trial NCT03502785?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2018-05-24. Estimated completion is 2025-05-09.
What interventions are being tested in trial NCT03502785?
The interventions under investigation include: Atezolizumab (DRUG), INO-5401 (BIOLOGICAL), INO-9012 (BIOLOGICAL), CELLECTRA™ 2000 (DEVICE).
Who is sponsoring clinical trial NCT03502785?
This trial is sponsored by Inovio Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03502785's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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