A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
Public ClinicalTrials.gov record NCT05933577. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-Risk Stage II-IV Melanoma (INTerpath-001)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05933577
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,089 participants
Conditions and interventions
Conditions
Interventions
- Intismeran autogene Biological
- Pembrolizumab Biological
- Placebo Other
Biological · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 19, 2023 (Actual)
- Primary completion
- Oct 26, 2029 (Estimated)
- Completion
- Sep 26, 2030 (Estimated)
- Last update posted
- Sep 24, 2025
2023 – 2030
United States locations
- U.S. sites
- 34
- U.S. states
- 19
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Highlands Oncology Group ( Site 1943) | Springdale | Arkansas | 72762 | — |
| UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1918) | Los Angeles | California | 90095 | — |
| UCSF Medical Center at Mission Bay ( Site 1929) | San Francisco | California | 94158 | — |
| Yale-New Haven Hospital-Yale Cancer Center ( Site 1933) | New Haven | Connecticut | 06510 | — |
| Orlando Health Cancer Institute ( Site 1937) | Orlando | Florida | 32806 | — |
| Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 1945) | Tampa | Florida | 33612 | — |
| Winship Cancer Institute of Emory University ( Site 1940) | Atlanta | Georgia | 30322 | — |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 1950) | Marietta | Georgia | 30060 | — |
| University of Iowa-Holden Comprehensive Cancer Center ( Site 1935) | Iowa City | Iowa | 52242 | — |
| Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Melanoma ( Site 1912) | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital ( Site 1927) | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center ( Site 1957) | Boston | Massachusetts | 02215 | — |
| Dana-Farber Cancer Institute ( Site 1956) | Boston | Massachusetts | 02215 | — |
| University of Michigan ( Site 1915) | Ann Arbor | Michigan | 48109 | — |
| Cancer and Hematology Centers of Western Michigan ( Site 1932) | Grand Rapids | Michigan | 49503 | — |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 1944) | Hackensack | New Jersey | 07601 | — |
| Atlantic Health System ( Site 1925) | Morristown | New Jersey | 07960 | — |
| Valley Health Systems - Ridgewood Campus ( Site 1947) | Ridgewood | New Jersey | 07450 | — |
| Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1958) | Mineola | New York | 11501 | — |
| NYU Langone Health-Perlmutter Cancer Center ( Site 1917) | New York | New York | 10016 | — |
| Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 1908) | New York | New York | 10032 | — |
| Memorial Sloan Kettering Cancer Center ( Site 1914) | New York | New York | 10065 | — |
| University of North Carolina Medical Center-Lineberger Comprehensive Cancer Center ( Site 1949) | Chapel Hill | North Carolina | 27599 | — |
| Duke Cancer Institute ( Site 1911) | Durham | North Carolina | 27710 | — |
| Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 1905) | Philadelphia | Pennsylvania | 19104 | — |
| UPMC Hillman Cancer Center ( Site 1909) | Pittsburgh | Pennsylvania | 15232 | — |
| Medical University of South Carolina-Hollings Cancer Center ( Site 1934) | Charleston | South Carolina | 29425 | — |
| Sanford Cancer Center ( Site 1951) | Sioux Falls | South Dakota | 57104 | — |
| SCRI Oncology Partners ( Site 1910) | Nashville | Tennessee | 37203 | — |
| Texas Oncology - Austin ( Site 1903) | Austin | Texas | 78731 | — |
| Texas Oncology - Dallas (Sammons) ( Site 1902) | Dallas | Texas | 75246 | — |
| University of Texas MD Anderson Cancer Center ( Site 1920) | Houston | Texas | 77030 | — |
| Inova Schar Cancer Institute ( Site 1900) | Fairfax | Virginia | 22031 | — |
| Fred Hutchinson Cancer Center ( Site 1901) | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 131 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05933577, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 24, 2025 · Synced Nov 1, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05933577 live on ClinicalTrials.gov.