RecruitingPhase 3NCT06929286

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

COMparative Prospective Assessment Through Clinically Integrated Randomized Trials Evaluating Intravesical Treatments: The COMPARE IT Trial

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

125 participants

Start Date

Apr 11, 2025

Study Type

INTERVENTIONAL

Conditions

Non Muscle Invasive Bladder Cancer

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).

Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study compares different treatments for people with high-grade non-muscle invasive bladder cancer (cancer that stays in the inner lining of the bladder) after the standard BCG immune therapy has stopped working. **You may be eligible if...** - You are 21 years or older - You have been diagnosed with high-grade non-muscle invasive bladder cancer - You have received at least one course of BCG and your urologist believes it has failed - You have received at least one intravesical (into the bladder) treatment in the past 12 months **You may NOT be eligible if...** - You have chosen to have your bladder removed (radical cystectomy) - You have previously received nadofaragene firadenovec (a specific bladder cancer treatment) - You are currently enrolled in another experimental treatment trial for bladder cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNadofaragene Firadenovec

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