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NCT06305767 · ClinicalTrials.gov registry record · Phase 1
A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)
A Phase 1 study of Bladder Cancer, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 1
- Development phase
- 230
- Enrollment target
- 20
- Study locations
NCT06305767: Active Phase 1 study of Bladder Cancer, sponsored by Merck Sharp & Dohme.
NCT06305767 is a Phase 1 study of Bladder Cancer that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 230 participants, below the 12,752-participant average among 175 other Bladder Cancer trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06305767, a Phase 1 study of Bladder Cancer, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 230 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
DFS is defined as the time from randomization until death from any cause, or presence of disease per investigator assessment with muscle-invasive (≥pT2) disease or any high-grade non-muscle invasive disease in the urothelial tract (upper tract or lower tract) on imaging and biopsy, and/or disease recurrence outside the urothelial tract on imaging with or without confirmation by biopsy. DFS will be reported for the Adjuvant Cohort.
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 |
What the registry record for NCT06305767 still lists
NCT06305767 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, below the 12,752-participant average among 175 other Bladder Cancer trials with a reported enrollment target (98% lower).
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.
NCT06305767 names 20 study sites across 16 states, led by Quebec, Texas, New South Wales.
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.
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).
Who is sponsoring clinical trial NCT06305767?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06305767's enrollment target sits among peer trials
230 53rd of 175 higher than 123 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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