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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06929286
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nadofaragene Firadenovec — DRUG
    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 — DRUG
    gemcitabine instilled intravesically for 1 h, then drained completely out of the bladder
  • Docetaxel — DRUG
    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

Study Details

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).

Key Dates

Start date
Apr 11, 2025
Status verified
May 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
125 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Johns Hopkins University (Data Collection Only)BaltimoreMaryland21287
Max Kates, MD
410-955-6100
Memorial Sloan Kettering Basking Ridge (Consent Only)Basking RidgeNew Jersey07920
Eugene Pietzak, MD
646-422-4781
Memorial Sloan Kettering Monmouth (Consent Only)MiddletownNew Jersey07748
Eugene Pietzak, MD
646-422-4781
Memorial Sloan Kettering Bergen (Consent Only)MontvaleNew Jersey07645
Eugene Pietzak, MD
646-422-4781
Memorial Sloan Kettering Suffolk - Commack (Consent Only)CommackNew York11725
Eugene Pietzak, MD
646-422-4781
Memorial Sloan Kettering Westchester (Consent Only)HarrisonNew York10604
Eugene Pietzak, MD
646-422-4781
Columbia University (Data Collection Only)New YorkNew York10032
Andrew Lenis, MD
212-305-0114
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Eugene Pietzak, MD
646-422-4781
Bernard Bochner, MD
646-422-4387
Eugene Pietzak, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Nassau (Consent Only)UniondaleNew York11553
Eugene Pietzak, MD
646-422-4781

Find similar trials in Baltimore, MD

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Johns Hopkins University (Data Collection Only)· Baltimore, MDMemorial Sloan Kettering Basking Ridge (Consent Only)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Consent Only)· Middletown, NJMemorial Sloan Kettering Bergen (Consent Only)· Montvale, NJMemorial Sloan Kettering Suffolk - Commack (Consent Only)· Commack, NYMemorial Sloan Kettering Westchester (Consent Only)· Harrison, NY

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