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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nadofaragene firadenovec | Experimental | The patient will receive nadofaragene firadenovec. |
|
| Best usual care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| high-grade recurrence-free survival | 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. | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Disease progression is defined as the development of muscle-invasive disease (stage ≥T2), lymph node or distant metastasis, or death without documented disease progression. | up to 24 months |
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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
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eugene Pietzak, MD | Contact | 646-422-4781 | pietzake@mskcc.org | |
| Bernard Bochner, MD | Contact | 646-422-4387 |
| Name | Affiliation | Role |
|---|---|---|
| Eugene Pietzak, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University (Data Collection Only) | Not yet recruiting | Baltimore | Maryland | 21287 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org
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| 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 |
|
| Memorial Sloan Kettering Basking Ridge (Consent Only) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
|
| Memorial Sloan Kettering Monmouth (Consent Only) | Recruiting | Middletown | New Jersey | 07748 | United States |
|
| Memorial Sloan Kettering Bergen (Consent Only) | Recruiting | Montvale | New Jersey | 07645 | United States |
|
| Memorial Sloan Kettering Suffolk - Commack (Consent Only) | Recruiting | Commack | New York | 11725 | United States |
|
| Memorial Sloan Kettering Westchester (Consent Only) | Recruiting | Harrison | New York | 10604 | United States |
|
| Columbia University (Data Collection Only) | Not yet recruiting | New York | New York | 10032 | United States |
|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
|
| Memorial Sloan Kettering Nassau (Consent Only) | Recruiting | Uniondale | New York | 11553 | United States |
|
| ID | Term |
|---|---|
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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