Comparing treatments for non-muscle invasive bladder cancer
COMparative Prospective Assessment Through Clinically Integrated Randomized Trials Evaluating Intravesical Treatments: The COMPARE IT Trial
This study is testing a new treatment called nadofaragene firadenovec against standard options for adults with non-muscle invasive bladder cancer who haven’t had success with previous treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | pembrolizumab |
| Locations | 9 sites (Baltimore, Maryland and 8 other locations) |
| Trial ID | NCT06929286 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with high-grade NMIBC who have experienced treatment failure with BCG.
Not a fit: Patients opting for radical cystectomy or currently enrolled in a clinical trial of an experimental therapy for NMIBC may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients with non-muscle invasive bladder cancer.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * Opting for treatment with radical cystectomy * Currently enrolled in a clinical trial of an experimental therapy for NMIBC * Prior exposure to nadofaragene firadenovec
Where this trial is running
Baltimore, Maryland and 8 other locations
- Johns Hopkins University (Data Collection Only) — Baltimore, Maryland, United States (Not_yet_recruiting)
- 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) — Harrison, New York, United States (Recruiting)
- Columbia University (Data Collection Only) — New York, New York, United States (Not_yet_recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Consent Only) — Uniondale, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.