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Compares treatment options for Non-Muscle Invasive Bladder Neoplasms
Official title A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer
ClinicalTrials.gov ID: NCT06919965
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 (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
- Phase 3: a large, late-stage study
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
- Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors...
- Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue) as...
- All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for high grade UC before...
- Participants must have had either: a. Adequate Induction (5 of 6 doses) and either 2 of 3 doses of Maintenance or 2 of 6 doses of second Induction of...
- Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2
You likely can't join if
- Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of...
- Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Allowed...
- Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or...
- A history of clinically significant polyuria with recorded 24 hour urine volumes greater than (\>) 4,000 milliliters (mL)
- Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
See the full eligibility criteria
- Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However...
- 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
- All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for high grade UC before randomization. For participants with lamina propria invasion (T1) on the screening...
- Participants must have had either: a. Adequate Induction (5 of 6 doses) and either 2 of 3 doses of Maintenance or 2 of 6 doses of second Induction of BCG with high-grade T1 disease at first disease assessment after...
- Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2
- Must be ineligible for or refusing radical cystectomy (RC)
- Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced...
- Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Allowed recent second or prior malignancies: a. Any malignancy that was not...
- Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 210
- A history of clinically significant polyuria with recorded 24 hour urine volumes greater than (\>) 4,000 milliliters (mL)
- Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
The study team makes the final eligibility decision.
Where it's taking place
- Sun City, Arizona, United States
- Los Angeles, California, United States
- Lakewood, Colorado, United States
- Atlanta, Georgia, United States
- Chicago Ridge, Illinois, United States
- Carmel, Indiana, United States
- Plymouth, Massachusetts, United States
- Royal Oak, Michigan, United States
- Omaha, Nebraska, United States
- Voorhees Township, New Jersey, United States
- Syracuse, New York, United States
- Centerville, Ohio, United States
- Cincinnati, Ohio, United States
- Middleburg Heights, Ohio, United States
- Springfield, Oregon, United States
- Bala-Cynwyd, Pennsylvania, United States
- Lancaster, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Myrtle Beach, South Carolina, United States
- Germantown, Tennessee, United States
+ 77 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 Sun City, Arizona, United States; Los Angeles, California, United States; Lakewood, Colorado, United States; Atlanta, Georgia, United States; Chicago Ridge, Illinois, United States; Carmel, Indiana, United States and 91 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.