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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to the date of death (approximately 4 years and 2 months)

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%

White blood cell count decreased

14%

Vomiting

14%

Neutropenia

14%

Thrombocytopenia

14%

Alanine aminotransferase increased

10%

Neutrophil count decreased

10%

Platelet count decreased

10%

Aspartate aminotransferase increased

Dizziness

Musculoskeletal pain

Diarrhea

Back pain

100%

80%

60%

40%

20%

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.

0 / 6Eligibility criteria met