Can DNA vaccines plus immunotherapy shrink hard-to-treat bladder cancer?

NCT ID NCT03502785

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether combining two DNA-based immunotherapies with the drug atezolizumab can help people with advanced urothelial carcinoma, a type of cancer of the bladder and urinary tract. The DNA therapies are injected into muscle and followed by a brief electric pulse to help cells take them up, aiming to train the immune system to attack the cancer. The study includes two groups: people whose cancer progressed after standard immunotherapy, and people who have not yet received treatment and cannot take cisplatin chemotherapy. Researchers measure safety, immune responses, and whether tumors shrink.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination of two DNA-based immunotherapies (INO-5401 and INO-9012) delivered by injection with an electric pulse device, plus the drug atezolizumab
What this could lead to
If it works, this combination could offer a new treatment option for advanced bladder and urinary tract cancer, especially for people who have not responded to standard immunotherapy or cannot take chemotherapy.
What could go wrong
This is an early-phase trial with a small number of participants, so the treatment may not prove effective or safe enough for wider use. Side effects from the immune-boosting therapy and the electric pulse delivery are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

35 people

The number who actually took part.

Started

Jul 2018

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Sign an Informed Consent Form (ICF); * Have histologically or cytologically documented locally advanced unresectable or metastatic/recurrent urothelial carcinoma (including renal pelvis, ureters, urinary bladder, and urethra); * For Cohort A: Participants who have radiographically confirmed disease progression during or following treatment with an anti-PD-1/PD-L1 based therapy; * For Cohort B: No prior chemotherapy for inoperable locally advanced or metastatic or recurrent UCa and ineligible ("unfit") for cisplatin-based chemotherapy; * Have measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; * Have a performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) Performance Scale; * Have life expectancy of \>/= 3 months; * Be willing to provide a tissue sample for pre-treatment intra-tumoral assessment of proinflammatory and immunosuppressive factors; * Have electrocardiogram (ECG) with no clinically significant findings as assessed by the investigator performed within 28 days prior to first dose; * Demonstrate adequate hematological, renal, hepatic, and coagulation function; * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 5 months after the last dose of study treatment; * For male participants: agreement not to father a child. Participants must be surgically sterile (e.g, vasectomy) or use contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 5 months after the last dose of study treatment. Exclusion Criteria: * Any approved anti-cancer therapy including chemotherapy, targeted small molecule therapy or radiation therapy within 2 weeks prior to trial Day 0 as well as current participation or recipient of treatment on a clinical trial within 28 days prior to Day 0; * Documented active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis; * Malignancies other than UCa within 3 years prior to Day 0, with the exception of those with negligible risk of metastasis or death treated with expected curative outcome; * Prior treatment with CD137 agonists or immune checkpoint blockade therapies; * Treatment with systemic immunostimulatory agents; * Treatment with systemic immunosuppressive medication; * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; * Known hypersensitivity allergy or contraindication to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the PD-1/PD-L1 inhibitor formulation; * Active or history of autoimmune disease or immune deficiency; * History or any evidence of interstitial lung disease; * History of human immunodeficiency virus (HIV); * Active hepatitis B or active hepatitis C; * Severe infections within 4 weeks prior to enrollment; * Received therapeutic oral or IV antibiotics within 2 weeks prior to Day 0; * History or current evidence of any condition, therapy or laboratory abnormality that might confound the results of the trial; interfere with the participant's participation for the full duration of the trial, or is negatively impacted by EP treatment, or is not in the best interest of the participant to participate in the opinion of the treating investigator; * Prior allogeneic stem cell or solid organ transplant; * Uncontrolled tumor-related pain; pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures; or, hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Columbia University, Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032, United States

  • Greenville Memorial Hospital

    Greenville, South Carolina, 29615, United States

  • H. Lee Moffitt Cancer Center & Research Institute, Inc.

    Tampa, Florida, 33612, United States

  • Inova Melanoma and Skin Cancer Center

    Fairfax, Virginia, 22031, United States

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Mayo Clinic Cancer Center

    Phoenix, Arizona, 85054, United States

  • New York University Langone Medical Center - Perlmutter Cancer Center

    New York, New York, 10016, United States

  • University of North Carolina School of Medicine

    Chapel Hill, North Carolina, 27599, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110, United States

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