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Virus Therapy

TAR-210 for Bladder Cancer (MoonRISe-1 Trial)

Phase 3
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be willing to undergo all study procedures 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
Must not have
Presence of any bladder or urethral anatomic feature that may prevent the safe insertion, indwelling use, removal of TAR-210 or passage of a urethral catheter for intravesical chemotherapy
Current indwelling urinary catheters, however, intermittent catheterization is acceptable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to the date of death (approximately 4 years and 2 months)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to see if a new treatment called TAR-210 is better than the standard chemotherapy for preventing the return of a certain type of bladder cancer.

Who is the study for?
This trial is for individuals with intermediate-risk non-muscle invasive bladder cancer (NMIBC) who can perform daily activities (ECOG status 0-2). They must have a specific FGFR mutation or fusion, be willing to undergo study procedures like cystoscopies and tumor removal, and have no remaining visible disease before starting the trial. People with another malignancy that won't affect the study are also eligible.
What is being tested?
The study aims to compare how well patients do without their bladder cancer returning when treated with TAR-210 versus standard single-agent intravesical chemotherapy such as Gemcitabine or MMC. Participants will be randomly assigned to receive one of these treatments.
What are the potential side effects?
While specific side effects for TAR-210 aren't listed here, typical side effects of intravesical therapies like Gemcitabine or MMC may include discomfort during administration, urinary frequency, burning sensation during urination, blood in urine, and potential risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to follow all study procedures and accept the assigned treatment.
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My visible bladder cancer was completely removed and confirmed by a recent cystoscopy.
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My cancer has a specific FGFR mutation.
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I can take care of myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I don't have bladder or urethral issues that would interfere with specific cancer treatments.
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I use a catheter temporarily but not permanently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to the date of death (approximately 4 years and 2 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to the date of death (approximately 4 years and 2 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease Free Survival (DFS)
Secondary study objectives
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores
High Grade Recurrence-free Survival (HG RFS)
+7 more

Side effects data

From 2014 Phase 4 trial • 45 Patients • NCT02000531
29%
Nausea
19%
Leukopenia
14%
Anaemia
14%
Vomiting
14%
Neutropenia
14%
Alanine aminotransferase increased
14%
White blood cell count decreased
14%
Thrombocytopenia
10%
Neutrophil count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
5%
Musculoskeletal pain
5%
Dizziness
5%
Diarrhea
5%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group A: TAR-210Experimental Treatment1 Intervention
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.
Group II: Group B: MMC or GemcitabineActive Control2 Interventions
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.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
993 Previous Clinical Trials
6,386,473 Total Patients Enrolled
Johnson & Johnson Enterprise Innovation Inc. Clinical TrialStudy DirectorJohnson & Johnson Enterprise Innovation Inc.
~360 spots leftby Jun 2028
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