Comparing treatments for non-muscle invasive bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness of nadofaragene firadenovec against standard treatments for non-muscle invasive bladder cancer (NMIBC), including gemcitabine, docetaxel, and BCG. Participants will be adults with high-grade NMIBC who have previously undergone BCG treatment and are deemed to have treatment failure. The study will evaluate the outcomes of these FDA-approved therapies to determine which provides better results for patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Memorial Sloan Kettering Basking Ridge (Consent Only)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Consent Only)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Consent Only)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk - Commack (Consent Only)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Consent Only)
  East White Plains, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Eugene Pietzak, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Eugene Pietzak, MD
• Email: pietzake@mskcc.org
• Phone: 646-422-4781

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NMIBC sample collection to test cancer monitoring biomarkers

  This study tests a blood, urine, and tumor tissue collection approach in people with high-risk non-muscle invasive bladder cancer to see if a molecular test can detect residual disease and monitor recurrence.

  Recruiting Natera, Inc. · Austin, Texas · NCT07763197

• Sequential Gemcitabine Plus Docetaxel vs Gemcitabine Plus Mitomycin C for BCG-Unresponsive NMIBC

  This study tests whether adding docetaxel after gemcitabine is better or worse than adding mitomycin C after gemcitabine for people with BCG-unresponsive high-grade non-muscle-invasive bladder cancer.

  Recruiting Phase 2 Blokhin's Russian Cancer Research Center · Moscow, Moscow · NCT07747740

• Is ongoing systemic immunotherapy needed after achieving tumor-free status in very-high-risk NMIBC?

  This study tests whether patients who have become tumor-free after a systemic immunotherapy-based bladder-sparing treatment can safely stop therapy and instead be watched closely.

  Recruiting at 4 sites Phase 2 Tianjin Medical University Second Hospital · Tianjin and 3 other locations · NCT07625527

• Comparing CT and MRI with VI-RADS for Bladder Cancer Staging

  This study tests how well CT and MRI with VI-RADS can correctly stage bladder cancer before surgery in adults.

  Recruiting Oslo University Hospital · Oslo · NCT07602010

• How bladder microbes and immune signals affect lower urinary tract health

  This project will test whether differences in bladder microbes and immune signals are linked to urinary tract health in adults with and without various urinary conditions.

  Recruiting University of Zurich · Zurich, Canton of Zurich · NCT07494864

• Cretostimogene for BCG‑unresponsive high‑grade non‑muscle‑invasive bladder cancer

  This treatment will test cretostimogene plus n‑dodecyl‑β‑D‑maltoside in adults whose high‑grade non‑muscle‑invasive bladder cancer did not respond to BCG (carcinoma in situ with or without Ta/T1 tumors).

  Recruiting at 14 sites Phase 2 Lepu Biopharma Co., Ltd. · Beijing, Beijing Municipality and 13 other locations · NCT07283835

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.