A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011) (NCT06833073)
A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)
🩺 Plain-English Summary (8th-Grade Level)
Researchers are looking for new ways to treat people with high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment. HR NMIBC can also include carcinoma in situ (CIS). CIS is bladder cancer that appears flat and is only in the inner layer (surface) of the bladder. CIS is not raised and is not growing toward the center of the bladder. The standard treatment for HR NMIBC is a procedure to remove the tumor called transurethral resection of the bladder tumor (TURBT) followed by Bacillus Calmette-Guerin (BCG). Standard treatment is something that is considered the first line of treatment for a condition. BCG is an immunotherapy, which is a treatment that helps the immune system fight cancer. However, BCG may not work to treat HR NMIBC in some people. Researchers want to learn if adding intismeran autogene, the study treatment, to standard treatment can help treat HR NMIBC. Intismeran autogene is designed to help a person's immune system attack their specific cancer. The goal of this study are to learn if people who receive V940 with BCG live longer and without the cancer growing, spreading, or coming back compared to people who receive BCG alone.
Who can join: Review the eligibility criteria below.
Location: Michael G Oefelein Clinical Trials ( Site 0138) — Bakersfield, California
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 (89 Sites)
Showing the first 25 of 89 sites.
- Michael G Oefelein Clinical Trials ( Site 0138) — Bakersfield, California
- Genesis Research, LLC ( Site 0141) — Los Alamitos, California
- USC Norris Comprehensive Cancer Center ( Site 0123) — Los Angeles, California
- Genesis Healthcare-Torrance ( Site 0140) — Torrance, California
- Genesis Research LLC ( Site 0118) — Torrance, California
- Urology Associates ( Site 0144) — Littleton, Colorado
- Urological Research Network ( Site 0133) — Hialeah, Florida
- Associated Urological Specialists - Chicago Ridge ( Site 0139) — Chicago Ridge, Illinois
- Southern Urology, LLC ( Site 0145) — Lafayette, Louisiana
- University of Missouri Health Care ( Site 0126) — Columbia, Missouri
- NHO Revive Research Institute, LLC ( Site 0137) — Lincoln, Nebraska
- Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0111) — New York, New York
- TriState Urologic Services PSC Inc. dba The Urology Group ( Site 0122) — Cincinnati, Ohio
- OHSU Knight Cancer Institute - South Waterfront ( Site 0110) — Portland, Oregon
- MidLantic Urology ( Site 0102) — Bala-Cynwyd, Pennsylvania
- The Conrad Pearson Clinic ( Site 0143) — Germantown, Tennessee
- Texas Oncology-Austin Central ( Site 0107) — Austin, Texas
- Urology Austin, PLLC ( Site 0109) — Austin, Texas
- Urology of Virginia ( Site 0125) — Virginia Beach, Virginia
- University of Washington - Fred Hutchinson Cancer Center ( Site 0100) — Seattle, Washington
- Hospital Italiano de Buenos Aires ( Site 0307) — CABA, Buenos Aires
- Instituto Alexander Fleming ( Site 0306) — Ciudad Autónoma de Buenos Aires, Buenos Aires
- Instituto de Investigaciones Clinicas Mar de Plata ( Site 0305) — Mar del Plata, Buenos Aires
- Asociación de Beneficencia Hospital Sirio Libanés ( Site 0303) — Buenos Aires, Buenos Aires F.D.
- Fundacion Estudios Clinicos ( Site 0304) — Rosario, Santa Fe Province
📞 Contact the Study Coordinator
Phone: (888) 577-8839
Email: Trialsites@msd.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 Urinary Bladder Neoplasms
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- A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer — Tucson, Arizona
- A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU) — Birmingham, Alabama
- Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992) — Washington D.C., District of Columbia
- 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 — Tucson, Arizona
Explore by condition: All Urinary Bladder Neoplasms 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.