← Back to Search

Virus Therapy

Group A: 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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

MoonRISe-1 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.Check my eligibility

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.See study design

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.

MoonRISe-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am willing to follow all study procedures and accept the assigned treatment.

Select...

My visible bladder cancer was completely removed and confirmed by a recent cystoscopy.

Select...

My cancer has a specific FGFR mutation.

Select...

I can take care of myself and am up and about more than 50% of my waking hours.

MoonRISe-1 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease Free Survival (DFS)

Secondary outcome measures

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%

White blood cell count decreased

14%

Vomiting

14%

Thrombocytopenia

14%

Alanine aminotransferase increased

14%

Anaemia

14%

Neutropenia

10%

Neutrophil count decreased

10%

Platelet count decreased

10%

Aspartate aminotransferase increased

Dizziness

Back pain

Diarrhea

Musculoskeletal pain

100%

80%

60%

40%

20%

Study treatment Arm

Erlotinib-Chemotherapy

Chemotherapy-Erlotinib

MoonRISe-1 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

977 Previous Clinical Trials

6,384,109 Total Patients Enrolled

Johnson & Johnson Enterprise Innovation Inc. Clinical TrialStudy DirectorJohnson & Johnson Enterprise Innovation Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks associated with Group A: TAR-210 for individuals participating in the study?

"Our evaluation at Power indicates that the safety rating for Group A: TAR-210 is classified as 3, corresponding to a Phase 3 trial with existing efficacy data and comprehensive safety records."

Answered by AI

Are potential participants currently able to apply for enrollment in this trial?

"According to details on clinicaltrials.gov, this research study is currently in the process of enrolling participants. The trial was initially listed on 4/18/2024 and last revised on 4/23/2024."

Answered by AI

In how many healthcare facilities is this clinical study currently being conducted?

"Conducted at esteemed institutions like Arkansas Urology in Little Rock, AR, Genesis Research LLC in Los Alamitos, CA, and Urology Associates in Sherman Oaks, TN; this study is also taking place at 8 additional sites."

Answered by AI

How many individuals are currently enrolled in this clinical study?

"A total of 540 eligible candidates are needed to enroll in this research study. Patients meeting the specified criteria can choose from several locations, including Arkansas Urology based in Little Rock, Arkansas and Genesis Research LLC located in Los Alamitos, California."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06319820.

All > Anaheim > Nashville