🏛️ Verified NIH Record • Updated 2026-08-27

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 (NCT04640623)

Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Janssen Research & Development, LLC

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: Del Sol Research Management, LLC — Tucson, Arizona

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (144 Sites)

Showing the first 25 of 144 sites.

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

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗