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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06319820




Registration number
NCT06319820
Ethics application status
Date submitted
13/03/2024
Date registered
20/03/2024

Titles & IDs
Public title
A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
Scientific 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
Secondary ID [1] 0 0
2023-507684-19
Secondary ID [2] 0 0
42756493BLC3004
Universal Trial Number (UTN)
Trial acronym
MoonRISe-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Muscle Invasive Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - TAR-210
Treatment: Drugs - Gemcitabine
Treatment: Drugs - MMC

Experimental: 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.

Active comparator: 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.


Other interventions: TAR-210
TAR-210 will be administered intravesically.

Treatment: Drugs: Gemcitabine
Gemcitabine will be administered intravesically.

Treatment: Drugs: MMC
MMC will be administered intravesically.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease Free Survival (DFS)
Timepoint [1] 0 0
From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months)
Secondary outcome [1] 0 0
Time to next Treatment (TTNT)
Timepoint [1] 0 0
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 outcome [2] 0 0
High Grade Recurrence-free Survival (HG RFS)
Timepoint [2] 0 0
From randomization to the date of first documented evidence of HG NMIBC or death (approximately 4 years and 2 months)
Secondary outcome [3] 0 0
Progression Free Survival (PFS)
Timepoint [3] 0 0
From randomization to the date of first documented disease progression or death (approximately 4 years and 2 months)
Secondary outcome [4] 0 0
Rate of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment
Timepoint [4] 0 0
From study treatment completion up to trial discontinuation (approximately 4 years and 2 months)
Secondary outcome [5] 0 0
Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities)
Timepoint [5] 0 0
From first dose up to 30 days after last dose of study treatment (approximately 4 years and 2 months)
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
From randomization to the date of death (approximately 4 years and 2 months)
Secondary outcome [7] 0 0
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores
Timepoint [7] 0 0
Baseline, Weeks 6, 12, 24, 36, and 48
Secondary outcome [8] 0 0
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores
Timepoint [8] 0 0
Baseline, Weeks 6, 12, 24, 36, and 48
Secondary outcome [9] 0 0
Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-C30 Scores
Timepoint [9] 0 0
Weeks 6, 12, 24, 36, and 48
Secondary outcome [10] 0 0
Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-NMIBC24 Scores
Timepoint [10] 0 0
Weeks 6, 12, 24, 36, and 48

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/06/2028
Actual
Sample size
Target
540
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Washington
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Caba
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Graz
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Linz
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Cheng Du Shi
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Chong Qing
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Fu Zhou Shi
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Roskilde
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Lille
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Lublin
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Wroclaw
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Spain
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A Coruna
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Barcelona
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Cadiz
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Castellon
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Spain
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Jerez De La Frontera
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Madrid
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Malaga
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Oviedo
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Sabadell
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Valencia
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Turkey
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Adana
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Ankara
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Istanbul
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Bristol
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Sheffield
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Southampton
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Johnson & Johnson Enterprise Innovation Inc. Clinical Trial
Address 0 0
Johnson & Johnson Enterprise Innovation Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& 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 (YODA) Project site at yoda.yale.edu
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06319820