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

Phase 3

Recruiting

• Conditions: Non-Muscle Invasive Bladder Cancer
• Interventions: Drug: Nadofaragene Firadenovec; Drug: Gemcitabine; Drug: Docetaxel

• Registration Number: NCT06929286
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-11
• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study First Posted: 2025-04-16
• Last Update Posted: 2025-04-16
• Primary Completion: 2028-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• 21 years of age or older

• Being treated for high-grade NMIBC (Tis, Ta, or T1) with one of the participating treating urologists at MSK

• 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

• 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 enrolled in a clinical trial of an experimental therapy for NMIBC
• Prior exposure to nadofaragene firadenovec

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nadofaragene firadenovec	Nadofaragene Firadenovec	The patient will receive nadofaragene firadenovec.
Best usual care	Gemcitabine	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.
Best usual care	Docetaxel	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 Measures

Name	Time	Method
high-grade recurrence-free survival	up 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.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	up to 24 months	Disease progression is defined as the development of muscle-invasive disease (stage ≥T2), lymph node or distant metastasis, or death without documented disease progression.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States