A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Running, not enrolling · Phase 2

Conditions studied: Urinary Bladder Neoplasms

In brief

The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).

Key facts

Study ID

NCT04640623

Run by

Janssen Research & Development, LLC

People needed

220

Starts

2020-12-18

Expected to finish

2027-09-30

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed diagnosis of persistent or recurrent high-risk non-muscle invasive bladder cancer (HR-NMIBC), (carcinoma in situ [CIS] or tumor in situ [Tis]), with or without papillary disease (T1, high-grade Ta) or papillary disease only (high-grade Ta or any T1 and absence of CIS), within 12 months of completion of the last dose of Bacillus Calmette-Guerin (BCG) therapy, in participants who have received adequate BCG. Mixed histology tumors are allowed if urothelial differentiation (transitional cell histology) is predominant. However, the presence of neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoid features will make a participant ineligible. For participants with lamina propria invasion (T1) on the screening biopsy/ transurethral resection of bladder tumor (TURBT), muscularis propria must be present in order to rule out Muscle Invasive Bladder Cancer (MIBC)
• All visible papillary disease must be fully resected (absent) prior to randomization (residual CIS is acceptable for participants eligible for Cohorts 1, 2, and 3 only) and documented in the electronic case report form (eCRF) at screening cystoscopy. For participants with papillary disease only (Cohort 4), local urine cytology at screening must be negative or atypical (for High-Grade Urothelial Carcinoma [HGUC])
• Participants must be ineligible for or have elected not to undergo radical cystectomy
• BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapy defined as a minimum of 5 of 6 full doses of an induction course (adequate induction) plus 2 of 3 doses of a maintenance course, or at least 2 of 6 doses of a second induction course
• Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2

You may not qualify if…

• Presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV)
• Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization
• Received a live virus vaccine within 30 days prior to the initiation of study treatment. Inactivated (non-live or non-replicating) vaccines approved or authorized for emergency use (for example, COVID-19) by local health authorities are allowed
• Active hepatitis B or C infection (for example, participants with history of hepatitis C infection but undetectable hepatitis C virus polymerase chain reaction (PCR) test and participants with history of hepatitis B infection with positive hepatitis B surface antigen (HBsAg) antibody and undetectable PCR are allowed)
• Prior therapy with an anti-programmed-cell death 1 (PD-1), anti-PD-ligand 2 (L2) agent, or with an agent directed to another co-inhibitory T-cell receptor

Where it is running

• University of Southern California — Los Angeles, California, United States
• Genesis Healthcare Partners - Genesis Research Greater Los Angeles — Sherman Oaks, California, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Foothills Urology - Golden Off — Golden, Colorado, United States
• DuPage Medical Group — Lisle, Illinois, United States
• Urology of Indiana — Greenwood, Indiana, United States
• Wichita Urology Group — Wichita, Kansas, United States
• Michigan Institute of Urology — Troy, Michigan, United States
• NYU Langone Health — New York, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Associated Medical Professionals — Syracuse, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• The Urology Group — Cincinnati, Ohio, United States
• Urologic Consultants of Southeastern Pennsylvania — Bala-Cynwyd, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Urology Associates, PC — Nashville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Urology Austin — Austin, Texas, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Urology San Antonio Research — San Antonio, Texas, United States
• Spokane Urology — Spokane, Washington, United States
• Flinders Medical Centre — Bedford Park, Australia
• Eastern Health Research — Box Hill, Australia
• Macquarie University Hospital — Sydney, Australia
• Del Sol Research Management, LLC — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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