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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age21+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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).

Eligibility criteria

Qualifiers

21 years of age or older

Being treated for high-grade NMIBC (Tis, Ta, or T1) with one 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

Disqualifiers

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

Treatments tested in this trial

  • Nadofaragene Firadenovec
  • Gemcitabine
  • Docetaxel

Treatment groups

125 Participants
are divided into 2 treatment groups