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

May 7, 2026 updated by: Memorial Sloan Kettering Cancer Center

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

125

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Bernard Bochner, MD
  • Phone Number: 646-422-4387

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Not yet recruiting
        • Johns Hopkins University (Data Collection Only)
        • Contact:
          • Max Kates, MD
          • Phone Number: 410-955-6100
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge (Consent Only)
        • Contact:
          • Eugene Pietzak, MD
          • Phone Number: 646-422-4781
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (Consent Only)
        • Contact:
          • Eugene Pietzak, MD
          • Phone Number: 646-422-4781
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (Consent only)
        • Contact:
          • Eugene Pietzak, MD
          • Phone Number: 646-422-4781
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk - Commack (Consent only)
        • Contact:
          • Eugene Pietzak, MD
          • Phone Number: 646-422-4781
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (Consent only)
        • Contact:
          • Eugene Pietzak, MD
          • Phone Number: 646-422-4781
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Eugene Pietzak, MD
          • Phone Number: 646-422-4781
        • Contact:
          • Bernard Bochner, MD
          • Phone Number: 646-422-4387
        • Principal Investigator:
          • Eugene Pietzak, MD
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Columbia University (Data Collection Only)
        • Contact:
          • Andrew Lenis, MD
          • Phone Number: 212-305-0114
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (Consent Only)
        • Contact:
          • Eugene Pietzak, MD
          • Phone Number: 646-422-4781

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nadofaragene firadenovec
The patient will receive nadofaragene firadenovec.
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.
Active Comparator: Best usual care
For patients randomized to receive best usual care, the combination of intravesical GemDoce is the current standard of care at MSK for most patients with BCG failure.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
high-grade recurrence-free survival
Time Frame: up to 24 months
The time from the initiation of treatment to the detection of recurrence of high-grade bladder cancer (biopsy-proven intravesical recurrence or distant metastasis). Biopsy proven high grade intravesical recurrence will be based on the MSK pathology review of the bladder tissue samples.
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: up to 24 months
Disease progression is defined as the development of muscle-invasive disease (stage ≥T2), lymph node or distant metastasis, or death without documented disease progression.
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Eugene Pietzak, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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