Recruiting

Phase 3

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

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06929286

Conditions

Non-Muscle Invasive Bladder Cancer

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Nadofaragene Firadenovec

Gemcitabine

Docetaxel

Study Details

Brief summary:

The purpose of this study is to compare the effectiveness of different FDA-approved/NCCN-recommended drug treatments for NMIBC. In particular, the FDA-approved drug nadofaragene firadenovec will be compared to usual care with other NCCN-recommended standard treatments for NMIBC (gemcitabine with or without docetaxel, mitomycin, re-treatment with BCG, or pembrolizumab).

Conditions

Non-Muscle Invasive Bladder Cancer

Study ID

NCT06929286

Start date

Apr 11, 2025

Status verified date

Aug, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

°Any amount of maintenance BCG is allowed

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 Criteria:

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

Study Design

Enrollment

125 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nadofaragene firadenovec

The patient will receive nadofaragene firadenovec.

active comparator: Best usual care

For patients randomized to receive best usual care, the combination of intravesical GemDoce is the current standard of care at MSK for most patients with BCG failure.

Interventions

Nadofaragene Firadenovec

For patients randomized to receive nadofaragene firadenovec, the patient will receive nadofaragene firadenovec as of normal saline instilled intravesically every 3 months for up to 12 months.

Gemcitabine

gemcitabine instilled intravesically for 1 h, then drained completely out of the bladder

Docetaxel

followed by docetaxel instilled intravesically for 1 h. This is given once weekly for 6 weeks for induction. Those who have a complete response typically proceed with once-monthly instillations of GemDoce for up to 24 months as maintenance therapy

Primary outcome measure

high-grade recurrence-free survival [ Time Frame: up to 24 months ]

Central Contacts and Locations

Central contacts

Eugene Pietzak, MD

646-422-4781 pietzake@mskcc.org

Bernard Bochner, MD

646-422-4387

Locations

Memorial Sloan Kettering Basking Ridge (Consent Only)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Eugene Pietzak, MD

646-422-4781

Memorial Sloan Kettering Monmouth (Consent Only)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Eugene Pietzak, MD

646-422-4781

Memorial Sloan Kettering Bergen (Consent Only)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Eugene Pietzak, MD

646-422-4781

Memorial Sloan Kettering Suffolk - Commack (Consent Only)

Recruiting

Commack, New York, United States, 11725

Contacts

Eugene Pietzak, MD

646-422-4781

Memorial Sloan Kettering Westchester (Consent Only)

Recruiting

East White Plains, New York, United States, 10604

Contacts

Eugene Pietzak, MD

646-422-4781

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Eugene Pietzak, MD

646-422-4781

Bernard Bochner, MD

646-422-4387

Principal Investigator:

Eugene Pietzak, MD

Memorial Sloan Kettering Nassau (Consent Only)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Eugene Pietzak, MD

646-422-4781

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-08-20.