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 up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2016

Completed Phase 3

~5860