Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,752-participant average among 175 other Bladder Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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
Similar trials for Bladder Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.
RECRUITING · Phase 1
-
KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04)
RECRUITING · Phase 1
-
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas
RECRUITING · Phase 1
-
A Study of MGC026 in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
-
Sacituzumab Govitecan Plus EV in Metastatic UC
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.