Status:
APPROVED_FOR_MARKETING
Pre-Approval Expanded Access Study for TAR-200 Treating Physician Use
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Non-Muscle Invasive Bladder Neoplasms
Eligibility:
All Genders
18+ years
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 canc...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06877676
Last Update
December 5 2025
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