Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer (NCT05951179)
A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer
🩺 Plain-English Summary (8th-Grade Level)
TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1). The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and efficacy of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a). This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease, defined as disease present at last tumor evaluation (within 3 months) prior to signing the ICF. Participants will be enrolled into one of 2 cohorts: Cohort A: * Participants with CIS (± Ta/T1) who are BCG naive, or * Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis Cohort B: * Participants who are BCG unresponsive
Who can join: Review the eligibility criteria below.
Location: Urology Centers of Alabama — Homewood, Alabama
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 (78 Sites)
Showing the first 25 of 78 sites.
- Urology Centers of Alabama — Homewood, Alabama
- Mayo Clinic — Phoenix, Arizona
- East Valley Urology Center of Arizona — Queen Creek, Arizona
- Arkansas Urology — Little Rock, Arkansas
- Michael Oefelein Clinical Trials — Bakersfield, California
- Urology Group of Southern California — Los Angeles, California
- University of California Irvine Medical Center — Orange, California
- Genesis Research — San Diego, California
- Genesis Research LLC — Torrance, California
- Colorado University - Anshutz — Aurora, Colorado
- AdventHealth Medical Group Urology of Denver — Denver, Colorado
- Advanced Urology — Lakewood, Colorado
- Urology Associates of Denver — Lone Tree, Colorado
- University of Florida Health Jacksonville — Gainesville, Florida
- Mayo Clinic — Jacksonville, Florida
- Comprehensive Urologic Care — Lake Barrington, Illinois
- Southern Urology — Lafayette, Louisiana
- Ochsner Health LSU - Regional Urology — Shreveport, Louisiana
- Brigham and Women's Hospital — Boston, Massachusetts
- Greater Boston Urology, LLC — Plymouth, Massachusetts
- Minnesota Urology, Woodbury — Bloomington, Minnesota
- Mayo Clinic — Rochester, Minnesota
- Renown Regional Medical Center — St Louis, Missouri
- Specialty Clinic Research of St. Louis — St Louis, Missouri
- AccuMed Research Associates — Garden City, New York
📞 Contact the Study Coordinator
Phone: (646) 844-0337
Email: clinicaltrials@protaratx.com
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 Non-muscle Invasive Bladder Cancer
- A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer — Birmingham, Alabama
- Study of CG0070 After Transurethral Resection in Patients With IR NMIBC — Tampa, Florida
- A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer — Tucson, Arizona
- Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention — Dallas, Texas
- A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer — Tampa, Florida
- Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment — Basking Ridge, New Jersey
Explore by condition: All Non-muscle Invasive Bladder Cancer clinical trials
💡 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.