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Monoclonal Antibodies

TAR-200 + Cetrelimab for Bladder Cancer (SunRISe-4 Trial)

Q: How many individuals are being accepted into this medical experiment?

This clinical trial necessitates 160 qualified patients for participation. These individuals can enrol at Genesis Research in San Diego, <a href="https://www.withpower.com/clinical-trials/california">California</a> or University of Pittsburgh Medical Center (UPMC) - Hillman <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center in <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a>.

Q: Are there multiple locations conducting this research within the United States?

30 different clinical trial sites are running this experiment, with notable locations in San Diego, Pittsburgh and Tucson. It is recommended to find the nearest centre so that travel requirements can be minimized if you decide to join.

Q: Are there any participation openings left in this experiment?

According to the data on clinicaltrials.gov, this trial is currently recruiting participants with a commencement date of July 7th 2022 and last update being November 3rd 2022.

Q: Has the FDA sanctioned TAR-200 for use in medical treatments?

The data surrounding TAR-200's safety is sufficient for us to assign it a score of 2. This drug has gone through Phase 2 clinical trials, with some evidence to support its security but none verifying its efficacy.

Q: Have other investigations utilized TAR-200 to test its efficacy?

The initial investigation of TAR-200 was conducted at Sanatorio de la Mujer in 2016. Since then, 4 studies have been concluded and 8 more are currently underway, with many trials taking place within the borders of <a href="https://www.withpower.com/clinical-trials/california">California</a>'s San Diego county.

Q: Has this experimental approach ever been undertaken before?

Presently, 8 active clinical trials for TAR-200 are being held in 92 cities across 35 countries. The inaugural experiment was sponsored by Janssen Research &#x26; Development, LLC and commenced in 2016 with 600 participants. Since then, 4 further studies have been concluded successfully.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 108

Awards & highlights

SunRISe-4 Trial 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.Check my eligibility

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.See study design

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.

SunRISe-4 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am fully active or can carry out light work.

Select...

All my side effects from past surgeries are mild now.

SunRISe-4 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 108

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants with Pathologic Complete Response (pCR)

Secondary outcome measures

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)

SunRISe-4 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,148 Total Patients Enrolled

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

745 Previous Clinical Trials

3,959,745 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

Frequently Asked Questions

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

How many individuals are being accepted into this medical experiment?

"This clinical trial necessitates 160 qualified patients for participation. These individuals can enrol at Genesis Research in San Diego, California or University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center in Pennsylvania."

Answered by AI

Are there multiple locations conducting this research within the United States?

"30 different clinical trial sites are running this experiment, with notable locations in San Diego, Pittsburgh and Tucson. It is recommended to find the nearest centre so that travel requirements can be minimized if you decide to join."

Answered by AI

Are there any participation openings left in this experiment?

"According to the data on clinicaltrials.gov, this trial is currently recruiting participants with a commencement date of July 7th 2022 and last update being November 3rd 2022."

Answered by AI

Has the FDA sanctioned TAR-200 for use in medical treatments?

"The data surrounding TAR-200's safety is sufficient for us to assign it a score of 2. This drug has gone through Phase 2 clinical trials, with some evidence to support its security but none verifying its efficacy."

Answered by AI

Have other investigations utilized TAR-200 to test its efficacy?

"The initial investigation of TAR-200 was conducted at Sanatorio de la Mujer in 2016. Since then, 4 studies have been concluded and 8 more are currently underway, with many trials taking place within the borders of California's San Diego county."

Answered by AI

Has this experimental approach ever been undertaken before?

"Presently, 8 active clinical trials for TAR-200 are being held in 92 cities across 35 countries. The inaugural experiment was sponsored by Janssen Research & Development, LLC and commenced in 2016 with 600 participants. Since then, 4 further studies have been concluded successfully."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder

2022. "A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04919512.

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