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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 3

Conditions: Non-Muscle Invasive Bladder Cancer

Treatments: Drug: Gemcitabine; Drug: Nadofaragene Firadenovec; Drug: Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT06929286

25-069

Details and patient eligibility

About

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).

Enrollment: 125 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

125 participants in 2 patient groups

Nadofaragene firadenovec

Experimental group

Description:

The patient will receive nadofaragene firadenovec.

Treatment:

Drug: Nadofaragene Firadenovec

Best usual care

Active Comparator group

Description:

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.

Treatment:

Drug: Docetaxel

Drug: Gemcitabine