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 Intermediate-risk 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)
Ote Tatsuya
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. 24, 2024
Sept. 11, 2024
540
Interventional
randomized controlled trial
open(masking not used)
active control
parallel assignment
treatment purpose
- 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
- 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
18age old over
No limit
Both
Non-Muscle Invasive Bladder Cancer
Experimental: Main Study: Group A: TAR-210
Participants in Group A will have TAR-210 inserted in the bladder on Day 1 and removed after 12 weeks.
One TAR-210 will be inserted every 12 weeks over a treatment period of approximately 1 year.
Combination Product: TAR-210
TAR-210 will be administered intravesically.
Other Names:
- JNJ-42756493
Active Comparator: Main Study: Group B: MMC or Gemcitabine
Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine (investigator's choice) once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year.
Drug: Gemcitabine
Gemcitabine will be administered intravesically.
Drug: MMC
MMC will be administered intravesically.
Experimental: Substudy: Group A: TAR-210
Participants in Group A will have TAR-210 inserted in the bladder on Day 1 and removed after 12 weeks.
One TAR-210 will be inserted every 12 weeks over a treatment period of approximately 1 year.
Combination Product: TAR-210
TAR-210 will be administered intravesically.
Other Names:
- JNJ-42756493
Active Comparator: Substudy: Group B: MMC
Participants in substudy Group B will receive intravesical MMC once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year.
Drug: MMC
MMC will be administered intravesically.
1. Disease Free Survival (DFS)
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.
[Time Frame: From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months)]
2. Time to next Treatment (TTNT)
TTNT is measured as the time from randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer.
[Time Frame: From randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer (approximately 4 years and 2 months)]
3. High Grade Recurrence-free Survival (HG RFS)
HG RFS is measured as the time from randomization to the date of first documented evidence of HG NMIBC or death, whichever occurs first
[Time Frame: From randomization to the date of first documented evidence of HG NMIBC or death (approximately 4 years and 2 months)]
4. Progression Free Survival (PFS)
PFS is measured as the time from randomization to the date of first documented evidence of disease progression or death, whichever occurs first.
[Time Frame: From randomization to the date of first documented disease progression or death (approximately 4 years and 2 months)]
5. Number of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment
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.
[Time Frame: From study treatment completion up to trial discontinuation (approximately 4 years and 2 months)]
6. Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities)
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.
[Time Frame: From first dose up to 30 days after last dose of study treatment (approximately 4 years and 2 months)]
7. Overall Survival (OS)
OS is defined as the time from randomization to the date of death from any cause.
[Time Frame: From randomization to the date of death (approximately 4 years and 2 months)]
8. European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores
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.
[Time Frame: Baseline, Weeks 6, 12, 24, 36, and 48]
9. European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores
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.
[Time Frame: Baseline, Weeks 6, 12, 24, 36, and 48]
10. Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-C30 Scores
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.
[Time Frame: Weeks 6, 12, 24, 36, and 48]
11. Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-NMIBC24 Scores
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.
[Time Frame: Weeks 6, 12, 24, 36, and 48]
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
Argentina/Australia/Austria/Belgium/Brazil/Canada/China/Czechia/Denmark/Finland/France/Germany/Hong Kong/Hungary/India/Ireland/Israel/Italy/Korea Republic Of/Mexico/Netherlands/New Zealand/Poland/Portugal/Spain/Sweden/Switzerland/Taiwan Province Of China/Turkey/United Kingdom Of Great Britain/United States Of America
