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

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called TAR-210 for patients with non-muscle invasive bladder cancer, which means the cancer is present in the bladder but hasn't spread to deeper tissues. The goal of the study is to see if TAR-210 can help patients live without signs of cancer for a longer time compared to standard treatments that involve chemotherapy directly delivered into the bladder. The trial is currently looking for participants aged 65 to 74 who have specific genetic markers related to their cancer, and who are willing to undergo several procedures to monitor their health during the study.

To be part of this trial, participants must have had their visible cancer completely removed and must not have any major health issues that could interfere with the treatment or testing. Throughout the study, participants will receive the assigned treatment and have regular check-ups, including tests to look inside the bladder. It’s important to note that while some people with other types of cancer may still participate, certain medical conditions or allergies may exclude them from joining the trial. This study aims to find out if TAR-210 can provide a better outcome for patients dealing with this type of cancer.

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Eligibility criteria

• Inclusion Criteria:
• • 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, b. Ta LG/G2: primary or recurrent and c. Greater than or equal to (\>=) 1 of the following risk factors: i. Multiple Ta LG tumors, ii. Solitary LG tumor \>= 3 cm, iii. Early recurrence (less than \[\<\] 1 year), iv. Frequent recurrence (greater than \[\>\] 1 per year), v. Recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor)
• • 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
• • 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
• Exclusion Criteria:
• • 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 \> 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)