Non-Muscle Invasive Bladder Cancer
Conditions
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).
Interventions
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.
DRUGGemcitabine
gemcitabine instilled intravesically for 1 h, then drained completely out of the bladder
DRUGDocetaxel
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
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTEugene Pietzak, MD
CONTACTBernard Bochner, MD
PRINCIPAL_INVESTIGATOREugene Pietzak, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed