INO-5401 + INO-9012 + Atezolizumab for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you stop any approved anti-cancer therapy, including chemotherapy, targeted therapy, or radiation therapy, at least 2 weeks before starting the trial. If you are on systemic immunostimulatory or immunosuppressive medications, you may also need to stop those.
Is the combination of INO-5401, INO-9012, and Atezolizumab safe for humans?
How is the drug combination of INO-5401, INO-9012, and Atezolizumab unique for bladder cancer treatment?
This drug combination is unique because it includes Atezolizumab, a monoclonal antibody that blocks PD-L1 to enhance the immune system's ability to fight cancer, and is combined with INO-5401 and INO-9012, which are designed to stimulate the immune system further. This approach aims to improve immune response against bladder cancer, offering a novel strategy compared to traditional chemotherapy.12345
What data supports the effectiveness of the drug Atezolizumab for bladder cancer?
Atezolizumab has been shown to be effective for advanced bladder cancer, with a 15% response rate in patients whose cancer progressed after first-line chemotherapy and a 24% response rate in those who were chemotherapy-naïve and ineligible for cisplatin. It has been approved by the FDA for use in these cases, demonstrating better response rates and survival compared to other treatments.12467
Who Is on the Research Team?
Jeffrey Skolnik, MD
Principal Investigator
Inovio Pharmaceuticals
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-in
A safety run-in will be performed with up to six participants from cohort A to evaluate safety and tolerability
Treatment
Participants receive INO-5401 and INO-9012 in combination with atezolizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Atezolizumab
- Electroporation
- INO-5401
- INO-9012
Atezolizumab is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Inovio Pharmaceuticals
Lead Sponsor