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A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)
NCT06305767 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Placebo
- BIOLOGICAL Intismeran autogene
- BIOLOGICAL Enfortumab Vedotin
- PROCEDURE Surgery (RC plus PLND)
Study Locations (20)
Quebec
- Centre Hospitalier de l'Université de Montréal ( Site 0005) — Montreal
- Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0001) — Québec
- Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0002) — Sherbrooke
Texas
- UT Southwestern Medical Center ( Site 0103) — Dallas
- Houston Methodist Hospital-Department of Urology ( Site 0111) — Houston
New South Wales
- Macquarie University-MQ Health Clinical Trials Unit ( Site 1803) — Macquarie University
- Westmead Hospital ( Site 1802) — Westmead
California
- UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0104) — Los Angeles
Florida
- AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0102) — Orlando
Illinois
- University of Chicago Medical Center ( Site 0109) — Chicago
Iowa
- University of Iowa ( Site 0110) — Iowa City
New York
- Icahn School of Medicine at Mount Sinai ( Site 0101) — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2024-03-28 |
| Est. Completion | 2031-10-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06305767
The ClinicalTrials.gov registry entry for NCT06305767 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06305767 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Quebec, Texas, New South Wales. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06305767 about?
NCT06305767 is a clinical study titled "A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)". 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 u...
What is the current status of trial NCT06305767?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 230 participants. The study started on 2024-03-28. Estimated completion is 2031-10-20.
What conditions does trial NCT06305767 study?
This clinical trial studies the following conditions: Bladder Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06305767?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (OTHER), Intismeran autogene (BIOLOGICAL), Enfortumab Vedotin (BIOLOGICAL), Surgery (RC plus PLND) (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06305767?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06305767 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Iowa, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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