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Comparing Treatments for Non-Muscle Invasive Bladder Cancer

This study is comparing different approved treatments for non-muscle invasive bladder cancer (NMIBC). You might be eligible if you are 21 or older, have high-grade NMIBC (Tis, Ta, or T1), and your doctor believes previous BCG treatment has not worked. The study will compare nadofaragene firadenovec to other standard treatments like gemcitabine, docetaxel, or a combination of these. The main goal is to see which treatment helps people stay free from high-grade cancer recurrence for up to 24 months. The study plans to enroll 125 people, but its current status is unclear.

Study design
This is an interventional study comparing different treatments. It plans to enroll 125 participants.
What's involved
If randomized to nadofaragene firadenovec, you would receive it in your bladder every 3 months for up to 12 months. If randomized to gemcitabine and docetaxel, you would receive weekly instillations for 6 weeks, followed by monthly instillations for up to 24 months if you respond well.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how long you remain free from high-grade cancer recurrence for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06929286

A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)

Recruiting
PHASE3Ages 21+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~125 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Nadofaragene FiradenovecGemcitabineDocetaxel

At a glance

Recruiting sites
7 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
high-grade recurrence-free survival
Measured over up to 24 months

Conditions

Non-Muscle Invasive Bladder Cancer

Explore related trials

Non-Muscle Invasive Bladder Carcinoma

NCT06929286

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Columbia University (Data Collection Only)

    New York, New Yorkstudy coordinator listed

    Not yet recruiting

  • Johns Hopkins University (Data Collection Only)

    Baltimore, Marylandstudy coordinator listed

    Not yet recruiting

  • Memorial Sloan Kettering Basking Ridge (Consent Only)

    Basking Ridge, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Bergen (Consent Only)

    Montvale, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Monmouth (Consent Only)

    Middletown, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Nassau (Consent Only)

    Uniondale, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Suffolk - Commack (Consent Only)

    Commack, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Eugene Pietzak, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Eugene Pietzak, MD
[email protected]
646-422-4781
Email the study team

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Eligibility criteria

Inclusion

21 years of age or older
Being treated for high-grade NMIBC (Tis, Ta, or T1) under the care of the participating treating urologists
One or more prior induction course of BCG at any point in time and judgment by the treating urologist that BCG has failed
In the previous 12 months, receipt of at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment
An intravesical agent can include BCG or any other NMIBC treatment
Up to 15 months from the last instillation is allowed for the treating physician to perform a transurethral resection of bladder tumor (TURBT) so long as there is evidence/suspicion of recurrent disease (by urinary cytology, imaging, or cystoscopy) within 12 months of last exposure to an intravesical agent.
In the opinion of the treating urologist, there is no contraindication to treatment with nadofaragene firadenovec (i.e. hypersensitivity to IFNa, severe immunosuppression) and there is uncertainty over whether nadofaragene is better than "best usual care"

Exclusion

Opting for treatment with radical cystectomy
Currently receiving treatment on a clinical trial of an experimental therapy for NMIBC
Prior exposure to nadofaragene firadenovec

What this trial measures

  • high-grade recurrence-free survivalup to 24 months

    The time from the initiation of treatment to the detection of recurrence of high-grade bladder cancer (biopsy-proven intravesical recurrence or distant metastasis). Biopsy proven high grade intravesical recurrence will be based on the MSK pathology review of the bladder tissue samples.