QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer (NCT03022825)
🩺 Plain-English Summary (8th-Grade Level)
This is a Phase II/III, open-label, single-arm, multicenter study of intravesical BCG plus N-803 or N-803 only in patients with BCG unresponsive high grade non-muscle invasive bladder cancer (NMIBC). All patients treated in the study will receive via a urinary catheter in the bladder, BCG plus N-803 or N-803 only weekly for 6 consecutive weeks (initial induction treatment period). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive maintenance treatment in the fourth treatment period at Months 24, 30, and 36. The study duration is 60 months.
Who can join: Review the eligibility criteria below.
Location: Alaska Clinical Research Center — Anchorage, Alaska
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 (28 Sites)
Showing the first 25 of 28 sites.
- Alaska Clinical Research Center — Anchorage, Alaska
- Arkansas Urology — Little Rock, Arkansas
- UCLA Department of Urology — Los Angeles, California
- Hoag Memorial Hospital — Newport Beach, California
- Skyline Urology — Sherman Oaks, California
- Skyline Urology — Torrance, California
- Urology Associates, PC — Englewood, Colorado
- University of Miami Miller School of Medicine-Sylvester Comprehensive Cancer Center — Miami, Florida
- Clinical Research Center of Florida — Pompano Beach, Florida
- Moffitt Cancer Center — Tampa, Florida
- Dwight D. Eisenhower Army Medical Center — Augusta, Georgia
- University of Hawaii Cancer Center — Honolulu, Hawaii
- University of Chicago Medical Center — Chicago, Illinois
- University of Michigan — Ann Arbor, Michigan
- Karmanos Cancer Institute — Detroit, Michigan
- Adult & Pediatric Urology — Omaha, Nebraska
- Accument Rx — Albuquerque, New Mexico
- Roswell Park Cancer Insitute — Buffalo, New York
- Winthrop University Hospital Department of Urology — Garden City, New York
- Integrated Medical Professionals — New York, New York
- Premier Medical Group of the Hudson Valley — Poughkeepsie, New York
- University of Rochester — Rochester, New York
- UNC Chapel Hill — Chapel Hill, North Carolina
- Associated Urologists of North Carolina — Raleigh, North Carolina
- Thomas Jefferson University — Philadelphia, Pennsylvania
💰 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.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.