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

NCT ID: NCT06877676

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: APPROVED_FOR_MARKETING
• Study Classification: EXPANDED_ACCESS

Brief 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

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participant has exhausted all clinically appropriate alternative forms of treatment and is not eligible for, or does not have access to, a clinical trial
• Histologically confirmed diagnosis of persistent or recurrent high-risk non-muscle-invasive bladder cancer (HR-NMIBC), carcinoma in situ (CIS) (OR Tis) with or without papillary disease (T1, high-grade Ta), within 12 months of completion of the last dose of BCG therapy, in participants who have received adequate Bacillus Calmette-Guérin (BCG)
• All visible papillary disease must be fully resected (absent) prior to initiation of treatment
• Participants must be ineligible for or have elected not to undergo Radical Cystectomy (RC)
• Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2

Exclusion Criteria

• Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV)
• Presence of any bladder or urethral anatomic feature that, in the opinion of the Investigator, may prevent the safe placement, indwelling use, or removal of TAR-200. Participants with tumors involving the prostatic urethra in men will be excluded
• Evidence of bladder perforation during diagnostic cystoscopy
• A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (>4000 mL)
• Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than HR-NMIBC

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Other Identifiers

17000139BLC4003

Identifier Type: OTHER

Identifier Source: secondary_id

17000139BLC4003

Identifier Type: -

Identifier Source: org_study_id