A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC) (NCT05714202)
A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic — Scottsdale, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (240 Sites)
Showing the first 25 of 240 sites.
- Mayo Clinic — Scottsdale, Arizona
- Arkansas Urology — Little Rock, Arkansas
- VA Long Beach Health Care System — Long Beach, California
- Genesis Research, LLC - West Coast Urology — Los Alamitos, California
- Cedars Sinai Medical Center — Los Angeles, California
- UC Davis Comprehensive Cancer Center — Sacramento, California
- Genesis Research — San Diego, California
- Providence Saint Johns Cancer Institute — Santa Monica, California
- Providence Medical Foundation — Santa Rosa, California
- Colorado Clinical Research — Lakewood, Colorado
- Urological Research Network — Hialeah, Florida
- Orlando Health Cancer Institute — Orlando, Florida
- Sarasota Memorial Hospital — Sarasota, Florida
- Grady Memorial Hospital — Atlanta, Georgia
- The Emory Clinic Department of Urology — Atlanta, Georgia
- Northwestern University — Chicago, Illinois
- Duly Health and Care — Lisle, Illinois
- Blessing Hospital — Quincy, Illinois
- Urology of Indiana — Carmel, Indiana
- First Urology — Jeffersonville, Indiana
- AMR Kansas City Oncology — Merriam, Kansas
- Wichita Urology Group — Wichita, Kansas
- Chesapeake Urology Research Associates — Hanover, Maryland
- Lahey Hospital & Medical Center — Burlington, Massachusetts
- University of Michigan — Ann Arbor, Michigan
📞 Contact the Study Coordinator
Phone: (800) 664-4580
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
More studies in Bladder Cancer
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- Trimodality Therapy With/Out Durvalumab to Treat Patients With Muscle-Invasive Bladder Cancer — Calgary, Alberta
- Determinants of Bladder Cancer Recurrence Study (The DETER Study) — Basking Ridge, New Jersey
- Quality of Life in Patients With Bladder Cancer — New York, New York
- A Phase II Study of Atezolizumab in Combination With Cisplatin + Gemcitabine Before Surgery to Remove the Bladder Cancer — Hartford, Connecticut
- A Diagnostic for the Early Detection of Bladder Cancer — Long Beach, California
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.