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Monoclonal Antibodies

TAR-200 + Cetrelimab vs Chemoradiotherapy for Bladder Cancer (SunRISe-2 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
Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
Ineligible for or have elected not to undergo radical cystectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights

SunRISe-2 Trial Summary

This trial will compare the effectiveness of two treatments for bladder cancer. One treatment is TAR-200 in combination with cetrelimab, and the other is concurrent chemoradiotherapy. The goal is to see which treatment leads to better BI-EFS (bladder cancer free survival).

Who is the study for?
This trial is for adults with muscle-invasive bladder cancer who can't have or chose not to get radical cystectomy. They should be relatively active (ECOG 0-2), recovered from previous treatments, and have normal thyroid function plus good bone marrow, liver, and kidney health.Check my eligibility
What is being tested?
The study compares the effectiveness of TAR-200 combined with cetrelimab against standard chemoradiotherapy in preserving the bladder. Participants are randomly assigned to either treatment group to measure which approach is better at preventing cancer progression.See study design
What are the potential side effects?
Possible side effects include typical reactions related to immunotherapy such as fatigue, skin issues, inflammation of organs; chemotherapy-related nausea, hair loss; radiation therapy may cause local skin irritation and discomfort.

SunRISe-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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I have chosen not to or cannot have major bladder surgery.
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All side effects from my previous surgery or bladder treatments have mostly gone away.
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- Your bone marrow, liver, and kidney need to work well: - Your bone marrow should produce enough blood cells without the need for extra support. - You should have a certain level of white blood cells, platelets, and hemoglobin. - Your liver should function normally. - Your kidneys should filter your blood well.

SunRISe-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 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
Time from Randomization to the First Bladder Intact Event-free Survival (BI-EFS) event
Secondary outcome measures
Metastasis-free survival (MFS)
Number of Participants with AEs by Severity according to Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)
Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE)
+3 more

SunRISe-2 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TAR-200 + CetrelimabExperimental Treatment2 Interventions
Participants will receive intravesical TAR-200 every 3 weeks (21 days indwelling) for first 18 weeks and thereafter from Week 24 every 12 weeks through study Year 3 in combination with intravenous (IV) Cetrelimab.
Group II: Chemotherapy (cisplatin or gemcitabine) + Radiation TherapyActive Control4 Interventions
Participants will receive chemotherapy based on investigator's choice from either cisplatin intravenously once weekly for 4 to 6 treatment weeks or gemcitabine intravenously twice weekly for 4 to 6 treatment weeks as Standard of Care (SOC) along with radiation therapy from either conventional radiotherapy (64 Gray [Gy], bladder only) for up to 6.5 treatment weeks or hypo-fractionated radiotherapy (55 Gy, bladder only) for up to 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetrelimab
2022
Completed Phase 1
~20
TAR-200
2017
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,758 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialsStudy DirectorJanssen Research & Development, LLC
11 Previous Clinical Trials
201,447 Total Patients Enrolled

Media Library

Cetrelimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04658862 — Phase 3
Bladder Cancer Research Study Groups: TAR-200 + Cetrelimab, Chemotherapy (cisplatin or gemcitabine) + Radiation Therapy
Bladder Cancer Clinical Trial 2023: Cetrelimab Highlights & Side Effects. Trial Name: NCT04658862 — Phase 3
Cetrelimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04658862 — Phase 3

Frequently Asked Questions

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

Has TAR-200 been cleared by the FDA for therapeutic use?

"TAR-200, which is currently in Phase 3 clinical trials, has received a safety score of 3. This is based on existing data that supports its efficacy as well as multiple rounds of testing affirming its safety."

Answered by AI

In how many distinct places is this clinical trial taking place?

"28 patients have already enrolled at locations such as CHU de Québec -L'Hôtel-Dieu de Québec in Québec, The Male/Female Health and Research Centre in Barrie, McGill University Health Centre in Montreal, with other enrollees at 28 additional sites."

Answered by AI

Could you share how many people are included in this clinical research?

"In order to conduct this clinical trial, a total of 550 eligible patients are required. Janssen Research & Development, LLC will be administering the study from their locations in Québec, Ontario and New jersey."

Answered by AI

What other research projects have included TAR-200 in their investigation?

"TAR-200 was first studied in 1997 and there have been a total of 1614 completed trials to date. Currently, 1015 live trials are underway, with many taking place in the Canadian provinces of Québec and Ontario."

Answered by AI

What is the typical use-case for TAR-200?

"According to current medical understanding, TAR-200 can be used to treat neoplasm metastasis, urinary bladder cancer, and advanced testicular cancer."

Answered by AI

Are there any patients who have not yet been enrolled in this study?

"The most recent information on clinicaltrials.gov suggests that this trial is still recruiting patients. 28 different sites across the country are looking for a total of 550 participants. The study was first posted on December 7th, 2020 and has been edited recently on November 3rd, 2022."

Answered by AI

Who else is applying?

What state do they live in?
New York
California
How old are they?
18 - 65
65+
What site did they apply to?
Associated Medical Professionals
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder
2020. "A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04658862.
All > Bladder Cancer
~244 spots leftby Dec 2026
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