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Monoclonal Antibodies

TAR-200 + Cetrelimab for Bladder Cancer (SunRISe-4 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 or 1
All adverse events associated with any prior surgery must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade < 2 prior to randomization
Must not have
Prior systemic chemotherapy for urothelial cell carcinoma of the bladder at any time
Must not have received prior systemic chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to starting study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 108
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the effectiveness of TAR-200, a new cancer drug, either alone or in combination with another immunotherapy drug, cetrelimab.

Who is the study for?
This trial is for adults with muscle-invasive bladder cancer that hasn't spread beyond the bladder and who haven't had systemic chemotherapy or radiation recently. They should be in good physical condition (ECOG 0-1) and have normal thyroid function or stable hormone levels. Tumors must be predominantly urothelial, not larger than 3cm after surgery, and participants must be fit for radical cystectomy.
What is being tested?
The study tests TAR-200 inserted into the bladder combined with cetrelimab given through IV, versus cetrelimab alone via IV. The goal is to see which treatment better reduces tumor size or prevents cancer from returning.
What are the potential side effects?
Possible side effects include immune-related reactions due to cetrelimab affecting organs like lungs or intestines, infusion reactions during drug administration, fatigue, skin issues, hormonal imbalances, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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All my side effects from past surgeries are mild now.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had chemotherapy for bladder cancer before.
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I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks.
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My cancer has not spread to distant organs, lymph nodes, or deeply into nearby tissues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 108
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 108 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants with Pathologic Complete Response (pCR)
Secondary study objectives
Number of Participants with Adverse Events (AEs) by Grades According to Common Terminology Criteria for Adverse Events (CTCAE)
Number of Participants with Change from Baseline in Laboratory Abnormalities
Recurrence-Free Survival (RFS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2: CetrelimabExperimental Treatment1 Intervention
Participants will receive cetrelimab.
Group II: Cohort 1: TAR-200 + CetrelimabExperimental Treatment2 Interventions
Participants will receive TAR-200 in combination with cetrelimab.
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
1,007 Previous Clinical Trials
6,403,287 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
772 Previous Clinical Trials
3,978,888 Total Patients Enrolled

Media Library

Cetrelimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04919512 — Phase 2
Bladder Cancer Research Study Groups: Cohort 1: TAR-200 + Cetrelimab, Cohort 2: Cetrelimab
Bladder Cancer Clinical Trial 2023: Cetrelimab Highlights & Side Effects. Trial Name: NCT04919512 — Phase 2
Cetrelimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04919512 — Phase 2
~10 spots leftby Feb 2025
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