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NCT05933577 · ClinicalTrials.gov registry record · Phase 3
A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
A Phase 3 study of Melanoma, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 1,089
- Enrollment target
- 20
- Study locations
NCT05933577: Active Phase 3 study of Melanoma, sponsored by Merck Sharp & Dohme.
NCT05933577 is a Phase 3 study of Melanoma that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 1,089 participants, above the 702-participant average among 266 other Melanoma trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05933577, a Phase 3 study of Melanoma, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,089 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to learn if intismeran autogene which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid \[mRNA\]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if intismeran autogene with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.
Primary Outcome
RFS is defined as the length of time from when the participant starts the study until either the cancer comes back, or the cancer spreads as assessed by the investigator, or death due to any cause.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Placebo
- BIOLOGICAL Intismeran autogene
Study Locations (20)
Massachusetts
- Massachusetts General Hospital ( Site 1927) - Boston
- Beth Israel Deaconess Medical Center ( Site 1957) - Boston
- Dana-Farber Cancer Institute ( Site 1956) - Boston
New Jersey
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 1944) - Hackensack
- Atlantic Health System ( Site 1925) - Morristown
- Valley Health Systems - Ridgewood Campus ( Site 1947) - Ridgewood
California
- UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1918) - Los Angeles
- UCSF Medical Center at Mission Bay ( Site 1929) - San Francisco
Florida
- Orlando Health Cancer Institute ( Site 1937) - Orlando
- Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 1945) - Tampa
Georgia
- Winship Cancer Institute of Emory University ( Site 1940) - Atlanta
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 1950) - Marietta
Michigan
- University of Michigan ( Site 1915) - Ann Arbor
- Cancer and Hematology Centers of Western Michigan ( Site 1932) - Grand Rapids
New York
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1958) - Mineola
- NYU Langone Health-Perlmutter Cancer Center ( Site 1917) - New York
Arkansas
- Highlands Oncology Group ( Site 1943) - Springdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,089 participants |
| Start Date | 2023-07-19 |
| Est. Completion | 2030-09-26 |
| Phase | Phase 3 |
What the registry record for NCT05933577 still lists
NCT05933577 is an interventional study that assigns participants to a tested intervention. Its 1,089 participants enrollment target places it among the larger protocols in the corpus, above the 702-participant average among 266 other Melanoma trials with a reported enrollment target (55% higher).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT05933577 names 20 study sites across 11 states, led by Massachusetts, New Jersey, California.
Frequently Asked Questions
What is clinical trial NCT05933577 about?
NCT05933577 is a clinical study titled "A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)". The purpose of this study is to learn if intismeran autogene which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid \[mRNA\]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to k...
What is the current status of trial NCT05933577?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,089 participants. The study started on 2023-07-19. Estimated completion is 2030-09-26.
What conditions does trial NCT05933577 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT05933577?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (OTHER), Intismeran autogene (BIOLOGICAL).
Who is sponsoring clinical trial NCT05933577?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05933577 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Melanoma
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.
Where NCT05933577's enrollment target sits among peer trials
1,089 18th of 266 higher than 249 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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