A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005) (NCT06305767)
A Phase 1/2 Study of V940 Plus Pembrolizumab With or Without Enfortumab Vedotin in Muscle-Invasive Urothelial Carcinoma (MIUC) (INTerpath-005)
🩺 Plain-English Summary (8th-Grade Level)
Researchers are looking for new ways to treat people with high-risk muscle-invasive urothelial carcinoma (MIUC). Urothelial carcinoma is a type of bladder cancer that begins in cells that line the inside of the bladder and other parts of the urinary tract, such as part of the kidneys, ureters, and urethra. People with MIUC usually have chemotherapy before surgery, then surgery to remove the cancer. Chemotherapy is a type of medicine to destroy cancer cells or stop them from growing. After surgery, some people receive more treatment to prevent cancer from returning. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Enfortumab vedotin (EV) is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to learn if giving intismeran autogene (the study treatment) with pembrolizumab can prevent MIUC from returning after surgery. Intismeran autogene (also called mRNA-4157) is designed to treat each person's cancer by helping the person's immune system identify and kill cancer cells based on certain proteins found on those cancer cells. The goals of this study are to learn if people who receive intismeran autogene and pembrolizumab are alive and cancer free longer than those who receive placebo and pembrolizumab, and to learn about the safety of intismeran autogene, pembrolizumab, and EV, and if people tolerate them.
Who can join: Review the eligibility criteria below.
Location: UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0104) — Los Angeles, 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 (74 Sites)
Showing the first 25 of 74 sites.
- UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0104) — Los Angeles, California
- AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0102) — Orlando, Florida
- University of Chicago Medical Center ( Site 0109) — Chicago, Illinois
- University of Iowa ( Site 0110) — Iowa City, Iowa
- Icahn School of Medicine at Mount Sinai ( Site 0101) — New York, New York
- Duke Cancer Institute ( Site 0107) — Durham, North Carolina
- Cleveland Clinic Main ( Site 0100) — Cleveland, Ohio
- Fox Chase Cancer Center ( Site 0106) — Philadelphia, Pennsylvania
- UT Southwestern Medical Center ( Site 0103) — Dallas, Texas
- Houston Methodist Hospital-Department of Urology ( Site 0111) — Houston, Texas
- Macquarie University-MQ Health Clinical Trials Unit ( Site 1803) — Macquarie University, New South Wales
- Westmead Hospital ( Site 1802) — Westmead, New South Wales
- Mater Misericordiae Limited ( Site 1808) — South Brisbane, Queensland
- One Clinical Research ( Site 1807) — Nedlands, Western Australia
- BC Cancer Vancouver ( Site 0004) — Vancouver, British Columbia
- Princess Margaret Cancer Centre ( Site 0003) — Toronto, Ontario
- Centre Hospitalier de l'Université de Montréal ( Site 0005) — Montreal, Quebec
- Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0001) — Québec, Quebec
- Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0002) — Sherbrooke, Quebec
- CIDO SpA ( Site 1509) — Temuco, Araucania
- Bradfordhill-Clinical Area ( Site 1501) — Recoleta, Santiago, Region M. de Santiago
- FALP ( Site 1500) — Santiago, Region M. de Santiago
- Pontificia Universidad Catolica de Chile ( Site 1503) — Santiago, Region M. de Santiago
- ONCOCENTRO APYS-ACEREY ( Site 1506) — Viña del Mar, Valparaiso
- Clínica Universitaria Colombia ( Site 1600) — Bogotá, Bogota D.C.
💰 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
- Study of CAbozantinib in Combination with AtezolizumaB for Muscle-Invasive BladdEr Cancer — St Louis, Missouri
- 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
Explore by condition: All Bladder Cancer clinical trials
💡 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.