TAR-200 for Bladder Cancer

Hosp. Univ. 12 De Octubre, Madrid, Spain
Bladder CancerTAR-200 - Drug
All Sexes
What conditions do you have?

Study 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.

Eligible Conditions
  • Bladder Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Up to 5 years

Year 3
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
Year 3
Cohort 1 and 3: Serum Concentration of Anti-cetrelimab Antibodies
Number of Participants with Anti-cetrelimab Antibodies
Up to 5 years
Duration of Response (DOR)
Number of Participants with Adverse Events (AEs) by Severity Grades
Overall Clinical Response (CR) Rate
Overall Complete Response (CR) Rate
Overall Survival (OS)
Up to Week 21
Cohort 1 and 2: Concentrations of Gemcitabine and 2',2' difluorodeoxyuridine (dFdU) in Urine and Plasma

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

Cohort 1: TAR-200 and Cetrelimab
1 of 3
Cohort 3: Cetrelimab
1 of 3
Cohort 2: TAR-200
1 of 3

Experimental Treatment

200 Total Participants · 3 Treatment Groups

Primary Treatment: TAR-200 · No Placebo Group · Phase 2

Cohort 1: TAR-200 and CetrelimabExperimental Group · 2 Interventions: Cetrelimab, TAR-200 · Intervention Types: Biological, Drug
Cohort 3: Cetrelimab
Experimental Group · 1 Intervention: Cetrelimab · Intervention Types: Biological
Cohort 2: TAR-200
Experimental Group · 1 Intervention: TAR-200 · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
942 Previous Clinical Trials
6,370,253 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
724 Previous Clinical Trials
3,952,411 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You cannot have or have chosen not to have surgery to remove your bladder.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.