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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 is a Phase 1 study that has completed, run by Inovio Pharmaceuticals. The registered enrollment target is 35 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03502785
The ClinicalTrials.gov registry entry for NCT03502785 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Inovio Pharmaceuticals, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Atezolizumab is the first listed.
NCT03502785 reports 0 study locations.
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.
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