Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06929286 | RECRUITING | Non-Muscle Invasive Bladder Cancer

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

Memorial Sloan Kettering Cancer Center

Brief Summary:

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).

Condition or disease

Non-Muscle Invasive Bladder Cancer

Intervention/treatment

Nadofaragene Firadenovec

Gemcitabine

Docetaxel

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 125 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : COMparative Prospective Assessment Through Clinically Integrated Randomized Trials Evaluating Intravesical Treatments: The COMPARE IT Trial
Actual Study Start Date : 2025-04-11
Estimated Primary Completion Date : 2028-04
Estimated Study Completion Date : 2028-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)

Location Details

NCT06929286

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065