Melanoma
Conditions
Brief 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.
Interventions
Sponsors
ModernaTX, Inc.
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Double blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-Free Survival (RFS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall-Survival (OS) | 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) | 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 | 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. |
| Distant Metastasis-Free Survival (DMFS) | 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. |
| Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 | 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 | 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. |
| 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 | 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. |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Germany, Greece, Israel, Italy, Japan, New Zealand, Poland, Portugal, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed