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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,089
Recurrence-Free Survival (RFS)
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.
Time frame: Up to approximately 74 months
Distant Metastasis-Free Survival (DMFS)
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.
Time frame: Up to approximately 85 months
Overall-Survival (OS)
OS is the length of time that people are alive after joining the study.
Time frame: Up to approximately 85 months
Number of Participants Who Experience an Adverse Event (AE)
An AE is a health problem that happens or worsens during a study. Number of participants who experience an AE will be reported.
Time frame: Up to approximately 68 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is a health problem that happens or worsens during a study. Number of participants who discontinue study treatment will be reported.
Time frame: Up to approximately 56 weeks
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
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.
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Highlands Oncology Group ( Site 1943)
Springdale, Arkansas, United States
UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1918)
Los Angeles, California, United States
UCSF Medical Center at Mission Bay ( Site 1929)
San Francisco, California, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 1933)
New Haven, Connecticut, United States
Orlando Health Cancer Institute ( Site 1937)
Orlando, Florida, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 1945)
Tampa, Florida, United States
Winship Cancer Institute of Emory University ( Site 1940)
Atlanta, Georgia, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 1950)
Marietta, Georgia, United States
University of Iowa-Holden Comprehensive Cancer Center ( Site 1935)
Iowa City, Iowa, United States
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Melanoma ( Site 1912)
Baltimore, Maryland, United States
...and 155 more locations
Time frame: Baseline and up to approximately 85 months
Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
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.
Time frame: Baseline and up to approximately 85 months
Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
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.
Time frame: Baseline and up to approximately 85 months