RECRUITINGPhase 3INTERVENTIONAL

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

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 21 years of age or older - Being treated for high-grade NMIBC (Tis, Ta, or T1) with one of the participating treating urologists at MSK - 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" Who Should NOT Join This Trial: - Opting for treatment with radical cystectomy - Currently enrolled in a clinical trial of an experimental therapy for NMIBC - Prior exposure to nadofaragene firadenovec Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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 at MSK * 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

Treatments Being Tested

DRUG

Nadofaragene 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.

DRUG

Gemcitabine

gemcitabine instilled intravesically for 1 h, then drained completely out of the bladder

DRUG

Docetaxel

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

Locations (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States