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Monoclonal Antibodies

TAR-200 + Cetrelimab for Bladder Cancer (SunRISe-1 Trial)

Phase 2

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

BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapy defined as a minimum of 5 of 6 full doses of an induction course (adequate induction) plus 2 of 3 doses of a maintenance course, or at least 2 of 6 doses of a second induction course

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

SunRISe-1 Trial Summary

This trial is testing TAR-200, a new immunotherapy drug, for bladder cancer. TAR-200 will be tested alone and in combination with cetrelimab, another immunotherapy drug, to see if it is effective in treating bladder cancer.

Who is the study for?

This trial is for adults with high-risk non-muscle invasive bladder cancer that hasn't responded to BCG therapy and who can't have or chose not to undergo bladder removal surgery. They should be mostly urothelial cancer type, without certain aggressive features, and must have a performance status that allows daily living activities.Check my eligibility

What is being tested?

The study tests TAR-200 (a drug-device combination) and Cetrelimab (an immunotherapy), alone or in combination, in four different participant groups based on their specific type of bladder cancer. The main goals are to see if the treatments completely remove the cancer or prevent it from returning.See study design

What are the potential side effects?

Potential side effects include typical reactions related to immunotherapies such as fatigue, skin reactions, inflammation of organs like lungs or intestines, hormonal gland problems, liver issues, and infusion-related reactions.

SunRISe-1 Trial Eligibility Criteria

Inclusion Criteria

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

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I am able to care for myself and perform daily activities.

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My bladder cancer did not respond to a full course of BCG treatment.

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My tumor is mainly urothelial but doesn’t have certain aggressive features.

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My bladder cancer has not invaded the muscle layer.

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

SunRISe-1 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

Cohort 1, 2, and 3: Overall Complete Response (CR) Rate

Cohort 4: 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

Cohort 1 and 3: Serum Concentration of Anti-cetrelimab Antibodies

+5 more

SunRISe-1 Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4: TAR-200 (Participants with Papillary Disease only)Experimental Treatment1 Intervention

TAR-200 is placed into the bladder through a urinary placement catheter in participants with papillary disease only, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).

Group II: Cohort 3: CetrelimabExperimental Treatment1 Intervention

Participants with CIS, with or without papillary disease, will receive Cetrelimab which will be dosed Q3W through Week 78 (18 months).

Group III: Cohort 2: TAR-200Experimental Treatment1 Intervention

TAR-200 is placed into the bladder through a urinary placement catheter in participants with CIS, with or without papillary disease, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).

Group IV: Cohort 1: TAR-200 and CetrelimabExperimental Treatment2 Interventions

TAR-200 is placed into the bladder through a urinary placement catheter in participants with carcinoma in situ (CIS), with or without papillary disease, on Day 0 and will be dosed every 3 weeks (Q3W) for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2). In addition, Cetrelimab will be dosed Q3W through Week 78 (18 months).

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,244 Total Patients Enrolled

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

745 Previous Clinical Trials

3,959,841 Total Patients Enrolled

Media Library

Cetrelimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04640623 — Phase 2

Bladder Cancer Research Study Groups: Cohort 4: TAR-200 (Participants with Papillary Disease only), Cohort 3: Cetrelimab, Cohort 1: TAR-200 and Cetrelimab, Cohort 2: TAR-200

Bladder Cancer Clinical Trial 2023: Cetrelimab Highlights & Side Effects. Trial Name: NCT04640623 — Phase 2

Cetrelimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04640623 — Phase 2

Frequently Asked Questions

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

Is recruitment currently ongoing for this research?

"Based on information posted to clinicaltrials.gov, this trial is actively recruiting participants and was initially listed online on December 18th 2020; the entry has since been modified as recent as November 3rd 2022."

Answered by AI

Are there numerous facilities offering this research study in the municipality?

"This trial is available at the University of Southern California in Los Angeles, Levine Cancer Institute in Charlotte, and Urologic Consultants of Southeastern Pennsylvania based in Bala-Cynwyd with 24 more sites spread around the United States."

Answered by AI

What is the maximum number of participants that are being welcomed into this investigation?

"In order to successfully launch this trial, 200 individuals that meet the set criteria must participate. Potential subjects can find medical facilities offering the treatment in both Los Angeles, California and Charlotte North carolina. Specifically, at University of Southern California and Levine Cancer Institute respectively."

Answered by AI

Has the Food and Drug Administration (FDA) sanctioned TAR-200 for use?

"Contingent on the clinical evidence available, our team has assigned TAR-200 a safety index of 2. This is due to it being in its Phase 2 trial stage, hence there are some data points for safety but not yet any for efficacy."

Answered by AI

To which ailments is TAR-200 typically prescribed?

"TAR-200 has been approved to manage small cell lung cancer (sclc) and can also be used for other carcinomas, such as head and neck, pancreatic adenocarcinoma locally advanced, and cervical cancers."

Answered by AI

What are the major goals of this medical study?

"Over the course of up to 5 years, this trial will assess the Overall Clinical Response Rate. Secondary metrics for evaluation include Overall Survival (time from randomization to death), Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder cancer 24 scores, and Number of Participants with Adverse Events by Severity Grades."

Answered by AI

Could you elaborate on other empirical investigations conducted with TAR-200?

"Currently, there are 452 TAR-200 trials in progress, 134 of which have reached Phase 3. Among these studies, 25021 locations offer research opportunities for the drug with a concentration of them located in Woolloongabba, Queensland."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

2020. "A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04640623.

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