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A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer (MoonRISe-1)

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ClinicalTrials.gov Identifier: NCT06319820
Recruitment Status : Recruiting
First Posted : March 20, 2024
Last Update Posted : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-Muscle Invasive Bladder Cancer Combination Product: TAR-210 Drug: Gemcitabine Drug: MMC Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 18, 2024
Estimated Primary Completion Date : June 28, 2028
Estimated Study Completion Date : June 28, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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Arm Intervention/treatment
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.
 Combination Product: TAR-210
TAR-210 will be administered intravesically.
Other Name: JNJ-42756493
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.
 Drug: Gemcitabine
Gemcitabine will be administered intravesically.

Drug: MMC
MMC will be administered intravesically.


Outcome Measures
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Primary Outcome Measures :
  1. Disease Free Survival (DFS) [ Time Frame: 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 non-muscle invasive bladder cancer (NMIBC) of any grade, disease progression, or death due to any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Time to next Treatment (TTNT) [ 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) ]
    TTNT is measured as the time from randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer.

  2. High Grade Recurrence-free Survival (HG RFS) [ Time Frame: 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

  3. Progression Free Survival (PFS) [ Time Frame: 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.

  4. Rate of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment [ Time Frame: 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.

  5. Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities) [ Time Frame: 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.

  6. Overall Survival (OS) [ Time Frame: 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.

  7. European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores [ Time Frame: 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.

  8. European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores [ Time Frame: 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.

  9. Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-C30 Scores [ Time Frame: 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.

  10. Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-NMIBC24 Scores [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06319820


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
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United States, Arkansas
Arkansas Urology Recruiting
Little Rock, Arkansas, United States, 72211
United States, California
Genesis Research LLC Recruiting
Los Alamitos, California, United States, 90720
Genesis Research LLC Recruiting
Sherman Oaks, California, United States, 91411
United States, Pennsylvania
MidLantic Urology Recruiting
Bala-Cynwyd, Pennsylvania, United States, 19004
United States, Tennessee
Urology Associates Recruiting
Nashville, Tennessee, United States, 37209
United States, Texas
Urology Austin Recruiting
Austin, Texas, United States, 78745
Israel
Hadassah University Hospita - Ein Kerem Recruiting
Jerusalem, Israel, 9112001
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Johnson & Johnson Enterprise Innovation Inc. Clinical Trial Johnson & Johnson Enterprise Innovation Inc.
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT06319820    
Other Study ID Numbers: 42756493BLC3004
2023-507684-19 ( EudraCT Number )
First Posted: March 20, 2024    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
URL: http://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
 Urologic Diseases
Male Urogenital Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents