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Virus Therapy

TAR-200 + Cetrelimab vs BCG for Bladder Cancer (SunRISe-3 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
All visible papillary disease must be fully resected (absent) prior to date of randomization and documented at baseline cystoscopy. Local urine cytology at screening must be negative or atypical (for high-grade urothelial carcinoma [HGUC]) for patients with papillary only disease (without CIS)
All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (<) 2 prior to date of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years 2 months
Awards & highlights

SunRISe-3 Trial Summary

This trial looks at survival rates of bladder cancer patients who have never had BCG treatment, comparing two treatments to BCG.

Who is the study for?
This trial is for individuals with high-risk non-muscle invasive bladder cancer who haven't had BCG therapy before. They should be in good enough health to participate, have no muscle-invasive or metastatic cancer, and not have significant urinary tract abnormalities that could interfere with treatment.Check my eligibility
What is being tested?
The study compares the effectiveness of TAR-200 combined with cetrelimab (Group A) and TAR-200 alone (Group C) against intravesical BCG therapy (Group B). The main goal is to see which group stays free from cancer events longer.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to cetrelimab, irritation or discomfort from TAR-200 device use, and typical local reactions associated with BCG such as pain during urination or blood in urine.

SunRISe-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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All visible signs of my bladder cancer have been surgically removed.
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All side effects from my previous treatments have mostly gone away.
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I have never had BCG therapy or stopped it over 3 years ago.
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My bladder cancer is aggressive but hasn't spread into the muscle, and I haven't had BCG treatment.
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I can take care of myself and am up and about more than half of my waking hours.

SunRISe-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years 2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years 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
Event-free Survival (EFS)
Secondary outcome measures
Cancer Specific Survival (CSS)
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of life Questionnaire - Non-muscle Invasive Bladder Cancer EORTC QLQ- NMIBC 24
Duration of CR
+9 more

SunRISe-3 Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Group C: TAR-200 AloneExperimental Treatment1 Intervention
Participants will receive intravesical TAR-200 alone once Q3W.
Group II: Treatment Group A: TAR-200 + CetrelimabExperimental Treatment2 Interventions
Participants will receive intravesical TAR-200 once every 3 weeks (Q3W) and cetrelimab.
Group III: Treatment Group B: Bacillus Calmette-Guerin (BCG) VesicultureActive Control1 Intervention
Participants will receive intravesical BCG once every week for 6 weeks (induction) and then followed by once every week for 3 weeks starting at Weeks 12, 24, 48, 72, and 96 (maintenance).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAR-200
2017
Completed Phase 1
~40
Cetrelimab
2022
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
974 Previous Clinical Trials
6,383,238 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,958,857 Total Patients Enrolled

Media Library

BCG Vesiculture (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05714202 — Phase 3
Bladder Cancer Research Study Groups: Treatment Group A: TAR-200 + Cetrelimab, Treatment Group B: Bacillus Calmette-Guerin (BCG) Vesiculture, Treatment Group C: TAR-200 Alone
Bladder Cancer Clinical Trial 2023: BCG Vesiculture Highlights & Side Effects. Trial Name: NCT05714202 — Phase 3
BCG Vesiculture (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05714202 — Phase 3

Frequently Asked Questions

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

How many facilities are currently hosting this research endeavor?

"This trial is presently seeking out patients from 40 diverse locations, including Little Rock, Duarte and Los Angeles. To lessen travel-related strain for participants, it is advised to enroll in the closest site available."

Answered by AI

Has the Food and Drug Administration (FDA) granted authorization for Treatment Group A: TAR-200 + Cetrelimab?

"The combination of TAR-200 and Cetrelimab has been found to be relatively safe, with available data supporting their efficacy in a clinical setting. Therefore, our team at Power assigned this treatment program an overall score of 3."

Answered by AI

Are there any vacancies to join this clinical trial?

"As indicated on clinicaltrials.gov, this research endeavour is no longer actively recruiting participants, having been posted in March of 2023 and last updated in late January of the same year. Despite not being an available opportunity for now, there are still 364 medical trials that require patient volunteers at present."

Answered by AI
~700 spots leftby Sep 2029