Non-Muscle Invasive Bladder Neoplasms
Conditions
Brief summary
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.
Interventions
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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, 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) * 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 following criteria fulfilled: a. Ta LG/G1, b. Ta LG/G2, and \>=1 of the following risk factors: i) Multiple Ta LG tumors, ii) Solitary LG tumor \>=3 cm * 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) Substudy: \- Previous diagnosis of histologically confirmed urothelial bladder carcinoma at any time prior to current qualifying diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival (DFS) | From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months) | DFS is measured as the time from randomization to the date of the first documented recurrence of Ta non-muscle invasive bladder cancer (NMIBC) of any grade, disease progression, or death due to any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to next Treatment (TTNT) | From randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer (approximately 4 years and 2 months) | TTNT is measured as the time from randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer. |
| High Grade Recurrence-free Survival (HG RFS) | From randomization to the date of first documented evidence of HG NMIBC or death (approximately 4 years and 2 months) | HG RFS is measured as the time from randomization to the date of first documented evidence of HG NMIBC or death, whichever occurs first |
| Progression Free Survival (PFS) | From randomization to the date of first documented disease progression or death (approximately 4 years and 2 months) | PFS is measured as the time from randomization to the date of first documented evidence of disease progression or death, whichever occurs first. |
| Number of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment | From study treatment completion up to trial discontinuation (approximately 4 years and 2 months) | Number of diagnostic and therapeutic invasive urological interventions after study treatment, that is, endoscopic procedures (e.g., cystoscopies, transurethral resection of bladder tumors (TURBTs), ureteroscopies, urethral interventions, urethral stricture/bladder neck incision), catheterization (intravesical, suprapubic), intravesical treatments, major surgeries (e.g., radical cystectomy, simple cystectomy, urethroplasty) will be reported. |
| Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities) | From first dose up to 30 days after last dose of study treatment (approximately 4 years and 2 months) | An AE is any untoward medical occurrence in a participant participating in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product, that does not necessarily have a causal relationship with the treatment. AEs will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening and Grade 5: Death. Number of participants with adverse events (including physical examination, vital signs and laboratory abnormalities) will be reported. |
| Overall Survival (OS) | From randomization to the date of death (approximately 4 years and 2 months) | OS is defined as the time from randomization to the date of death from any cause. |
| European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores | Baseline, Weeks 6, 12, 24, 36, and 48 | EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It incorporates 5 functional scales (physical, role, cognitive, emotional, and social functioning), 3 symptom scales (fatigue, pain, and nausea or vomiting), and a global health status or HRQoL scale. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity. |
| European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores | Baseline, Weeks 6, 12, 24, 36, and 48 | EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with non-muscle-invasive bladder cancer. The questionnaire is designed to supplement the QLQ C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity. |
| Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-C30 Scores | Weeks 6, 12, 24, 36, and 48 | EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the HRQoL of participants participating in cancer clinical studies. It incorporates 5 functional scales (physical, role, cognitive, emotional, and social functioning), 3 symptom scales (fatigue, pain, and nausea or vomiting), and a global health status or HRQoL scale. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity. |
| Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-NMIBC24 Scores | Weeks 6, 12, 24, 36, and 48 | EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with non-muscle-invasive bladder cancer. The questionnaire is designed to supplement the QLQ C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity. |
Countries
Argentina, Austria, Belgium, Brazil, China, Czechia, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Poland, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJohnson & Johnson Enterprise Innovation Inc. Clinical Trial
Johnson & Johnson Enterprise Innovation Inc.
Outcome results
None listed