RECRUITING

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

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Conditions

Non-Muscle Invasive Bladder Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2025-04-11
Study Completion:2028-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06929286

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.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 21 years of age or older
  2. * Being treated for high-grade NMIBC (Tis, Ta, or T1) with one of the participating treating urologists at MSK
  3. * One or more prior induction course of BCG at any point in time and judgment by the treating urologist that BCG has failed
  4. * 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
  5. * 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"
  1. * Opting for treatment with radical cystectomy
  2. * Currently enrolled in a clinical trial of an experimental therapy for NMIBC
  3. * Prior exposure to nadofaragene firadenovec

Contacts and Locations

Study Contact

Eugene Pietzak, MD
CONTACT
646-422-4781
pietzake@mskcc.org
Bernard Bochner, MD
CONTACT
646-422-4387

Principal Investigator

Eugene Pietzak, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

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

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 Registration Dates

Study Start Date2025-04-11
Study Completion Date2028-04

Study Record Updates

Study Start Date2025-04-11
Study Completion Date2028-04

Terms related to this study

Additional Relevant MeSH Terms

  • Non-Muscle Invasive Bladder Cancer