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

Description

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).

Conditions

Non-Muscle Invasive Bladder Cancer

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Study Overview

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Study Details

Study 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).

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

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

Condition
Non-Muscle Invasive Bladder Cancer
Intervention / Treatment

-

Contacts and Locations

New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, United States, 10065

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * 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"
  • * Opting for treatment with radical cystectomy
  • * Currently enrolled in a clinical trial of an experimental therapy for NMIBC
  • * Prior exposure to nadofaragene firadenovec

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Eugene Pietzak, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2028-04