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Treatment Group C: TAR-200 Alone for Bladder Cancer

Korea University Anam Hospital, Seoul, Korea, Republic of
Bladder CancerBCG Vesiculture - Biological
Eligibility
18+
All Sexes
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Study Summary

This trial looks at survival rates of bladder cancer patients who have never had BCG treatment, comparing two treatments to BCG.

Eligible Conditions
  • Bladder Cancer

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

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Study Objectives

1 Primary · 12 Secondary · Reporting Duration: Up to 5 years 2 months

Year 5
Cancer Specific Survival (CSS)
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of life Questionnaire - Non-muscle Invasive Bladder Cancer EORTC QLQ- NMIBC 24
Duration of CR
Event-free Survival (EFS)
Number of Participants with Adverse Events (AEs)
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
Number of Participants with Change from Baseline in Vital Signs Abnormalities
Overall Complete Response (CR) Rate
Overall Survival (OS)
Recurrence-Free Survival (RFS)
Time to Progression (TTP)
Time to Symptom Deterioration as Assessed by EORTC-QLQ-NMIBC 24 Scores

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Durvalumab
2
Bacillus Calmette-Guérin
1
Gemcitabine

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3 Treatment Groups

Treatment Group C: TAR-200 Alone
1 of 3
Treatment Group A: TAR-200 + Cetrelimab
1 of 3
Treatment Group B: Bacillus Calmette-Guerin (BCG) Vesiculture
1 of 3

Experimental Treatment

1050 Total Participants · 3 Treatment Groups

Primary Treatment: Treatment Group C: TAR-200 Alone · No Placebo Group · Phase 3

Treatment Group C: TAR-200 Alone
Drug
Experimental Group · 1 Intervention: TAR-200 · Intervention Types: Drug
Treatment Group A: TAR-200 + CetrelimabExperimental Group · 2 Interventions: TAR-200, Cetrelimab · Intervention Types: Drug, Biological
Treatment Group B: Bacillus Calmette-Guerin (BCG) Vesiculture
Biological
Experimental Group · 1 Intervention: BCG Vesiculture · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAR-200
2017
Completed Phase 1
~40

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years 2 months

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
942 Previous Clinical Trials
6,369,403 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
724 Previous Clinical Trials
3,951,561 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

How many facilities are currently hosting this research endeavor?

"This trial is presently seeking out patients from 40 diverse locations, including Little Rock, Duarte and Los Angeles. To lessen travel-related strain for participants, it is advised to enroll in the closest site available." - Anonymous Online Contributor

Unverified Answer

Has the Food and Drug Administration (FDA) granted authorization for Treatment Group A: TAR-200 + Cetrelimab?

"The combination of TAR-200 and Cetrelimab has been found to be relatively safe, with available data supporting their efficacy in a clinical setting. Therefore, our team at Power assigned this treatment program an overall score of 3." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies to join this clinical trial?

"As indicated on clinicaltrials.gov, this research endeavour is no longer actively recruiting participants, having been posted in March of 2023 and last updated in late January of the same year. Despite not being an available opportunity for now, there are still 364 medical trials that require patient volunteers at present." - 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.

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