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Checkpoint Inhibitor

INO-5401 + INO-9012 + Atezolizumab for Bladder Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Inovio Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, weeks 3, 6, 9, 12 and every 12 weeks thereafter up to end of study (up to approximately 2 years)
Awards & highlights

Summary

This trial is testing a new cancer treatment for people with advanced urothelial carcinoma who have either progressed on previous treatment or are ineligible for cisplatin-based chemotherapy. The safety and efficacy of the treatment will be evaluated.

Who is the study for?
This trial is for adults with advanced bladder cancer that's either come back or can't be removed by surgery. Cohort A must have worsened on anti-PD-1/PD-L1 therapy, while Cohort B are those who haven't had chemo and can't take cisplatin. Participants need to be fairly healthy, able to provide a tissue sample, and not planning to conceive.Check my eligibility
What is being tested?
The study tests INO-5401 + INO-9012 (DNA plasmids) given via injection followed by electroporation, combined with the immunotherapy drug Atezolizumab. It aims to see if this mix boosts the immune system against bladder cancer cells in patients previously treated and new patients unfit for standard chemo.See study design
What are the potential side effects?
Possible side effects include typical reactions at the injection site like pain or swelling, flu-like symptoms from immune activation such as fever or fatigue, allergic reactions due to Atezolizumab which might affect organs like lungs or liver, and potential heart rhythm changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, weeks 3, 6, 9, 12 and every 12 weeks thereafter up to end of study (up to approximately 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, weeks 3, 6, 9, 12 and every 12 weeks thereafter up to end of study (up to approximately 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Antigen-Specific Cellular Immune Response
Number of Adverse Events
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator Review in Cohort A
Secondary outcome measures
Duration of Response (DoR)
ORR by Immune RECIST (iRECIST)
ORR by RECIST version 1.1 by Investigator Review in Cohort B
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort BExperimental Treatment4 Interventions
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.
Group II: Cohort AExperimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INO-9012
2014
Completed Phase 2
~150
Atezolizumab
2017
Completed Phase 3
~5860
CELLECTRA™ 2000
2020
Completed Phase 2
~480

Find a Location

Who is running the clinical trial?

Inovio PharmaceuticalsLead Sponsor
53 Previous Clinical Trials
4,804 Total Patients Enrolled
Jeffrey Skolnik, MDStudy DirectorInovio Pharmaceuticals
12 Previous Clinical Trials
659 Total Patients Enrolled

Media Library

Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03502785 — Phase 1 & 2
Bladder Cancer Research Study Groups: Cohort B, Cohort A
~2 spots leftby Dec 2024
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