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Compares treatment options for Non-Muscle Invasive Bladder Neoplasms
Official title A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
ClinicalTrials.gov ID: NCT06319820
What this study is testing
What is TAR-210?
TAR-210 is an investigational medicine, being studied as a potential treatment for non-muscle invasive bladder neoplasms.
Also referred to as JNJ-42756493.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Main study only: Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria...
- Substudy only: Have a histologically confirmed new diagnosis (within 90 days of randomization) of IR-NMIBC for whom MMC is deemed the therapy of...
- Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue)...
- Participants must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for...
- Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy
You likely can't join if
- Known allergies, hypersensitivity, or intolerance to any study component or its excipients, including: a. Erdafitinib excipients; b.TAR-210 drug...
- Presence of any bladder or urethral anatomic feature (that is, urethral stricture) that, in the opinion of the investigator, may prevent the safe...
- Polyuria with recorded 24-hour urine volumes \> 4000 milliliters (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...
See the full eligibility criteria
- Main study only: Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: a. Ta low grade (LG)/ Grade 1 (G1): primary or recurrent...
- Substudy only: Have a histologically confirmed new diagnosis (within 90 days of randomization) of IR-NMIBC for whom MMC is deemed the therapy of choice according to local standard of care with at least 1 of the...
- 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...
- Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy
- 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 how well it works of the study...
- 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...
- 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...
- Polyuria with recorded 24-hour urine volumes \> 4000 milliliters (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) Substudy: \- Previous diagnosis of histologically confirmed...
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- San Diego, California, United States
- Sherman Oaks, California, United States
- Aurora, Colorado, United States
- Lakewood, Colorado, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Jeffersonville, Indiana, United States
- Wichita, Kansas, United States
- New Orleans, Louisiana, United States
- Hanover, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Royal Oak, Michigan, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- New Brunswick, New Jersey, United States
+ 139 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Los Alamitos, California, United States; Los Angeles, California, United States; Orange, California, United States; San Diego, California, United States; Sherman Oaks, California, United States and 153 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.