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Virus Therapy

Group A: TAR-200 for Bladder Cancer (SunRISe-5 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 ineligible for or have elected not to undergo Radical Cystectomy (RC)

Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

SunRISe-5 Trial Summary

This trial aims to compare the time period where participants with high-risk non-muscle-invasive bladder cancer experience no signs of the disease after receiving different treatments. The study will focus on individuals who had

Who is the study for?

This trial is for people with high-risk bladder cancer that came back within a year after BCG therapy and who can't have or don't want full bladder removal surgery. They should be able to perform daily activities (ECOG grade 0-2) and not have certain rare cancer types.Check my eligibility

What is being tested?

The study compares TAR-200, a new treatment, with the doctor's choice of standard chemotherapy drugs like Mitomycin C or Gemcitabine in patients refusing or unfit for radical cystectomy. It focuses on how long patients stay free from cancer after treatment.See study design

What are the potential side effects?

Possible side effects include irritation in the bladder, urinary symptoms, nausea, skin rash, fatigue, and potential allergic reactions to the treatments used.

SunRISe-5 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have chosen not to or cannot undergo major bladder surgery.

Select...

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

SunRISe-5 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years 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

Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores

Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) - C30 Scores

DFS Rate at 12 and 24 Months

+9 more

SunRISe-5 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group A: TAR-200Experimental Treatment1 Intervention

Participants will receive intravesical TAR-200 every 3 weeks during an induction phase and every 12 weeks during a maintenance phase.

Group II: Group B: Mitomycin C (MMC) or GemcitabineActive Control2 Interventions

Participants will receive either single agent intravesical MMC or gemcitabine every week during an induction phase and every 4 weeks during a maintenance phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAR-200

2017

Completed Phase 1

~40

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

977 Previous Clinical Trials

6,384,450 Total Patients Enrolled

Janssen Research & Development, LLC Clinical trialStudy DirectorJanssen Research & Development, LLC

9 Previous Clinical Trials

2,049 Total Patients Enrolled

Frequently Asked Questions

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

At how many distinct venues is this medical trial currently being conducted?

"This research study is being conducted at Genesis Research LLC in Los Alamitos, Arkansas, Samsung Medical Center in Little Rock, Indiana, and Arkansas Urology in Torrance, Tennessee. Additionally, it is taking place at 9 more sites across various regions."

Answered by AI

What is the current number of individuals being recruited for participation in this research study?

"A total of 250 eligible participants are required for enrollment in this medical investigation. Patients meeting the defined eligibility criteria can engage in the trial at various sites, such as Genesis Research LLC in Los Alamitos, Arkansas, and Samsung Medical Center in Little Rock, Indiana."

Answered by AI

What are the safety considerations associated with Group A: TAR-200 for individuals?

"According to our assessment at Power, the safety rating for Group A: TAR-200 is 3. This evaluation aligns with it being a Phase 3 trial, indicating existing efficacy data and robust safety records."

Answered by AI

Are new participants currently being enrolled in this ongoing clinical trial?

"Indeed, as per clinicaltrials.gov data, this research endeavor is actively seeking participants. The trial was initially listed on April 9, 2024, with the most recent update made on April 23, 2024. Recruitment aims to enroll a total of 250 individuals across nine distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)

2024. "A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06211764.

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