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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

Study 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
Atezolizumab
2017
Completed Phase 3
~5860
INO-9012
2014
Completed Phase 2
~150
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants in this investigation?

"Unfortunately, the recruitment period for this clinical trial has already concluded. Initially posted on May 24th 2018 and last edited October 7th 2022, it is no longer accepting participants. On a positive note though, there are currently 2518 studies recruiting patients with carcinoma and 357 trials for Atezolizumab still searching for volunteers."

Answered by AI

For what medical applications is Atezolizumab commonly employed?

"Atezolizumab is frequently utilized to treat small cell lung cancer (SCLC), as well as malignant neoplasms, non-small cell lung carcinoma, and postoperative conditions."

Answered by AI

Can you outline the prior investigations surrounding Atezolizumab?

"Atezolizumab was first investigated in 2008 at SCRI Tennessee Oncology Chattanooga. There are currently 89 completed trials and 357 active ones, with a large number of them situated around Saint Louis, Missouri."

Answered by AI

Does this study introduce any innovative approaches that have not been tested before?

"Hoffmann-La Roche kicked off the research into Atezolizumab back in 2008 and, following a successful trial involving 720 patients, it earned Phase 2 approval. Nowadays, 357 clinical trials are presently active for this drug across 74 countries and 1646 cities."

Answered by AI

How many venues are hosting this experiment?

"Currently, 20 different medical centres are enrolling participants for this clinical trial. This includes Washington University School of Medicine in St Louis, Indiana University Simon Cancer Center in Indianapolis and Alaska Clinical Research Centre LLC in Anchorage among other sites."

Answered by AI

Is enrollment for this trial still open to participants?

"This clinical trial is no longer enrolling participants, the last update being posted on October 7th 2022. However those searching for similar studies may take heart in knowing that there are currently 2518 trials recruiting patients with carcinoma and 357 seeking volunteers to partake in Atezolizumab treatment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma
2018. "INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03502785.
~5 spots leftby Apr 2025
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