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Pre-Approval Expanded Access Study for TAR-200 Treating Physician Use

NCT06877676 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2026-04-13

No results posted yet for this study

Summary

The purpose of this pre-approval access program is to provide access to TAR-200 prior to its marketing authorization for the treatment of participant(s) with high-risk non-muscle invasive bladder cancer (HR-NMIBC).

Conditions

  • Non-Muscle Invasive Bladder Neoplasms

Interventions

DRUG

TAR-200

Participants will undergo insertion of TAR-200 transurethrally into the bladder via catherization using the co-packed urinary placement catheter only in accordance with the Instructions for Use (IFU).

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06877676 on ClinicalTrials.gov