A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

Description

The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.

Conditions

Non-Muscle Invasive Bladder Cancer

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Study Overview

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Study Details

Study overview

The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.

A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations

A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

Condition
Non-Muscle Invasive Bladder Cancer
Intervention / Treatment

-

Contacts and Locations

Little Rock

Arkansas Urology, Little Rock, Arkansas, United States, 72211

Los Alamitos

Genesis Research LLC, Los Alamitos, California, United States, 90720

Los Angeles

USC Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90033

Orange

University of California Irvine Medical Center, Orange, California, United States, 92868

San Diego

Genesis Research, San Diego, California, United States, 92123

Sherman Oaks

Genesis Research LLC, Sherman Oaks, California, United States, 91411

Lakewood

Colorado Clinical Research, Lakewood, Colorado, United States, 80228

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Jeffersonville

First Urology, Jeffersonville, Indiana, United States, 47130

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

  • * Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determined by central or local testing
  • * Participants must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence/progression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that arm.
  • * Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy. The same method for visualizing disease at Screening cystoscopy should be used throughout for the participant (white light versus enhanced assessment method)
  • * Can have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
  • * Have an Eastern Cooperative Oncology Group performance status of 0 to 2
  • * Known allergies, hypersensitivity, or intolerance to any study component or its excipients, including: a. Erdafitinib excipients; b.TAR-210 drug delivery system constituent materials ; c. urinary placement catheter materials; d. MMC or chemically related drugs; e. Gemcitabine or chemically related drugs
  • * Presence of any bladder or urethral anatomic feature (that is, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-210 or passage of a urethral catheter for intravesical chemotherapy
  • * Polyuria with recorded 24-hour urine volumes greater than (\>) 4000 mL
  • * Current indwelling urinary catheters, however, intermittent catheterization is acceptable
  • * Had major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose (TURBT is not considered major surgery)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Johnson & Johnson Enterprise Innovation Inc. Clinical Trial, STUDY_DIRECTOR, Johnson & Johnson Enterprise Innovation Inc.

Study Record Dates

2028-06-28