A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
- 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.
- Short title
- A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
- 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)
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2030-09-26
- First posted
- 2023-07-06
- Registry last updated
- 2025-09-24
- Primary completion date
- 2029-10-26
- Start date
- 2023-07-19
- Participants
- 1,089
- Participant count basis
- Estimated
- Planned participants
- 1,089
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Merck Sharp & Dohme LLC
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05933577
- ClinicalTrials.gov ID
- NCT05933577
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Triple masking
- Masking description
- Double blind
- Masked roles
- Participants, Investigators, Outcome assessors
Recurrence-Free Survival (RFS)
Timeframe: Up to approximately 74 months
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.
Distant Metastasis-Free Survival (DMFS)
Timeframe: Up to approximately 85 months
DMFS is the length of time from when the participant starts the study until either the cancer spreads from where it started to other parts of the body as assessed by the investigator, or death due to any cause.
Overall-Survival (OS)
Timeframe: Up to approximately 85 months
OS is the length of time that people are alive after joining the study.
Number of Participants Who Experience an Adverse Event (AE)
Timeframe: Up to approximately 68 weeks
An AE is a health problem that happens or worsens during a study. Number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE
Timeframe: Up to approximately 56 weeks
An AE is a health problem that happens or worsens during a study. Number of participants who discontinue study treatment will be reported.
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
Timeframe: Baseline and up to approximately 85 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" will be scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better overall health status. Per protocol, the change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Timeframe: Baseline and up to approximately 85 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better level of physical functioning. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.
Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
Timeframe: Baseline and up to approximately 85 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a more impaired level of role functioning. Change from baseline in the role functioning (EORTC QLQ-C30 Items 6-7) combined score will be presented.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
The main inclusion criteria include but are not limited to the following:
- Has surgically resected and histologically/pathologically confirmed diagnosis of Stage IIB or IIC, III, or IV cutaneous melanoma
- Has not received any prior systemic therapy for their melanoma beyond surgical resection
- No more than 13 weeks have passed between final surgical resection that rendered the participant disease-free and the first dose of pembrolizumab
- Is disease free at the time of providing documented consent for the study
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
The main exclusion criteria include but are not limited to the following:
- Has ocular or mucosal melanoma
- Has cancer that has spread to other parts of the body and cannot be removed with surgery
- Has heart failure within the past 6 months
- Has received prior cancer therapy or another cancer vaccine
- Has another known cancer that that has spread to other parts of the body or has required treatment within the past 3 years
- Has severe reaction to study medications or any of their substance used to prepare a drug
- Have not recovered from major surgery or have ongoing surgical complications
- Highlands Oncology Group ( Site 1943)Springdale, United States
- UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1918)Los Angeles, United States
- UCSF Medical Center at Mission Bay ( Site 1929)San Francisco, United States
- Yale-New Haven Hospital-Yale Cancer Center ( Site 1933)New Haven, United States
- Orlando Health Cancer Institute ( Site 1937)Orlando, United States
- Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 1945)Tampa, United States
- Winship Cancer Institute of Emory University ( Site 1940)Atlanta, United States
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 1950)Marietta, United States
- University of Iowa-Holden Comprehensive Cancer Center ( Site 1935)Iowa City, United States
- Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Melanoma ( Site 1912)Baltimore, United States
- Massachusetts General Hospital ( Site 1927)Boston, United States
- Beth Israel Deaconess Medical Center ( Site 1957)Boston, United States
- Dana-Farber Cancer Institute ( Site 1956)Boston, United States
- University of Michigan ( Site 1915)Ann Arbor, United States
- Cancer and Hematology Centers of Western Michigan ( Site 1932)Grand Rapids, United States
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 1944)Hackensack, United States
- Atlantic Health System ( Site 1925)Morristown, United States
- Valley Health Systems - Ridgewood Campus ( Site 1947)Ridgewood, United States
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1958)Mineola, United States
- NYU Langone Health-Perlmutter Cancer Center ( Site 1917)New York, United States
- Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 1908)New York, United States
- Memorial Sloan Kettering Cancer Center ( Site 1914)New York, United States
- University of North Carolina Medical Center-Lineberger Comprehensive Cancer Center ( Site 1949)Chapel Hill, United States
- Duke Cancer Institute ( Site 1911)Durham, United States
- Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 1905)Philadelphia, United States
And 140 more, listed on the interactive page.
- Related resource (www.merckclinicaltrials.com)
- V940-001
- 2023
- U1111-1287-6366
- jRCT2041230169
- 2023-503652-27-00
Related records
Drugs (2)
Collaborators (1)
Lead sponsors (1)
Conditions (1)
- Melanoma Primary condition