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The trial is taking place at:
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Keystone Urology Specialists | Lancaster, PA

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

Janssen (J&J Innovative Medicine) logo

Janssen (J&J Innovative Medicine)

Status and phase

Enrolling
Phase 3

Conditions

Non-Muscle Invasive Bladder Cancer

Treatments

Drug: Gemcitabine
Drug: MMC
Combination Product: TAR-210

Study type

Interventional

Funder types

Industry

Identifiers

NCT06319820
42756493BLC3004
2023-507684-19 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

540 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

540 participants in 2 patient groups

Group A: TAR-210
Experimental group
Description:
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.
Treatment:
Combination Product: TAR-210
Group B: MMC or Gemcitabine
Active Comparator group
Description:
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.
Treatment:
Drug: MMC
Drug: Gemcitabine

Trial contacts and locations

27

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Central trial contact

Study Contact

Data sourced from clinicaltrials.gov

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