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Recruiting NCT06929286

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

Phase III Interventional Non-Muscle Invasive Bladder Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nadofaragene Firadenovec, Gemcitabine, Docetaxel.
Who it may be relevant to
Registry conditions: Non-Muscle Invasive Bladder Cancer. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • 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

Primary outcome measures

  • high-grade recurrence-free survival [Time frame: up to 24 months]
Secondary outcome measures (1)
  • Progression-free survival [Time frame: up to 24 months]

Eligibility criteria

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 positive 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 9 centers
  • Johns Hopkins University (Data Collection Only) — Baltimore
  • Memorial Sloan Kettering Basking Ridge (Consent Only) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Consent Only) — Middletown
  • Memorial Sloan Kettering Bergen (Consent Only) — Montvale
  • Memorial Sloan Kettering Suffolk - Commack (Consent Only) — Commack
  • Memorial Sloan Kettering Westchester (Consent Only) — East White Plains
  • Columbia University (Data Collection Only) — New York
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
  • … and 1 more center

Identifiers

NCT: NCT06929286 · 25-069

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗