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 Intermediaterisk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations (MoonRISe-1)
A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer (MoonRISe-1)
Fujikawa Ei
Janssen Pharmaceutical K.K.
5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo
+81-120-183-275
DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Medical Information Center
Janssen Pharmaceutical K.K.
5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo
+81-120-183-275
DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Recruiting
June. 28, 2024
540
Interventional
randomized controlled trial
open(masking not used)
active control
parallel assignment
treatment purpose
- 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)
18age old over
No limit
Both
Non-Muscle Invasive Bladder Cancer
TAR-210
TAR-210 will be administered intravesically.
Gemcitabine
Gemcitabine will be administered intravesically.
MMC
MMC will be administered intravesically.
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 nonmuscle invasive bladder cancer (NMIBC) of any grade, disease progression, or death due to any cause, whichever occurs first.
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.
Rate of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment
From study treatment completion up to trial discontinuation (approximately 4 years and 2 months)
Rate 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 (EORTCQLQ-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 nonmuscle- 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 nonmuscle-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.
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access
NCT06319820
ClinicalTrials.gov
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