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

Non-Muscle Invasive Bladder Cancer Clinical Trial

— MoonRISe-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06319820
• Other study ID #: 42756493BLC3004
• Secondary ID: 2023-507684-19
• Status: Recruiting
• Phase: Phase 3
• Start date: April 18, 2024
• Est. completion date: June 28, 2028

Study information

• Verified date: April 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: June 28, 2028
• Est. primary completion date: June 28, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

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 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)

Related Conditions & MeSH terms

• Non-Muscle Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Combination Product:
• TAR-210
TAR-210 will be administered intravesically.

Drug:
• Gemcitabine
Gemcitabine will be administered intravesically.
• MMC
MMC will be administered intravesically.

Locations

Country	Name	City	State
Israel	Hadassah University Hospita - Ein Kerem	Jerusalem
United States	Urology Austin	Austin	Texas
United States	MidLantic Urology	Bala-Cynwyd	Pennsylvania
United States	Arkansas Urology	Little Rock	Arkansas
United States	Genesis Research LLC	Los Alamitos	California
United States	Urology Associates	Nashville	Tennessee
United States	Genesis Research LLC	Sherman Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival (DFS)	DFS is measured as the time from randomization to the date of the first documented recurrence of non-muscle invasive bladder cancer (NMIBC) of any grade, disease progression, or death due to any cause, whichever occurs first.	From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months)
Secondary	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.	From randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer (approximately 4 years and 2 months)
Secondary	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	From randomization to the date of first documented evidence of HG NMIBC or death (approximately 4 years and 2 months)
Secondary	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.	From randomization to the date of first documented disease progression or death (approximately 4 years and 2 months)
Secondary	Rate of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment	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.	From study treatment completion up to trial discontinuation (approximately 4 years and 2 months)
Secondary	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.	From first dose up to 30 days after last dose of study treatment (approximately 4 years and 2 months)
Secondary	Overall Survival (OS)	OS is defined as the time from randomization to the date of death from any cause.	From randomization to the date of death (approximately 4 years and 2 months)
Secondary	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.	Baseline, Weeks 6, 12, 24, 36, and 48
Secondary	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.	Baseline, Weeks 6, 12, 24, 36, and 48
Secondary	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.	Weeks 6, 12, 24, 36, and 48
Secondary	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.	Weeks 6, 12, 24, 36, and 48