Melanoma
Conditions
Keywords
mRNA-4157, Individualized Neoantigen Therapy, INT, Pembrolizumab, Moderna
Brief summary
The purpose of this study is to assess whether postoperative adjuvant therapy with mRNA-4157 and pembrolizumab improves recurrence free survival (RFS) compared to pembrolizumab alone in participants with complete resection of cutaneous melanoma and a high risk of recurrence.
Interventions
BIOLOGICALPembrolizumab
Intravenous infusion
DRUGmRNA-4157
Individualized Neoantigen Therapy
Sponsors
Merck Sharp & Dohme LLC
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence * Complete resection within 13 weeks prior to the first dose of pembrolizumab * Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases * Has an formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 * Normal organ and marrow function reported at screening Key
Exclusion criteria
* Prior malignancy, unless no evidence of that disease for at least 5 years prior to study entry * Prior systemic anti-cancer treatment (except surgery and interferon for thick primary melanomas. Radiotherapy after lymph node dissection is permitted) * Live vaccine within 30 days prior to the first dose of pembrolizumab * Transfusion of blood or administration of colony stimulating factors within 2 weeks of the screening blood sample * Active autoimmune disease * Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab * Solid organ or allogeneic bone marrow transplant * Pneumonitis or a history of (noninfectious) pneumonitis that required steroids * Prior interstitial lung disease * Clinically significant heart failure * Known history of human immunodeficiency virus (HIV) * Known active hepatitis B or C * Active infection requiring treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-Free Survival (RFS), Assessed Using Radiological Imaging | Up to 7 years | RFS is defined as the time between the date of first dose of pembrolizumab and the date of recurrence (local, regional, or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distant Metastasis-Free Survival (DMFS), Assessed Using Radiological Imaging | Up to 7 years | DMFS is defined as the time between the date of first dose of pembrolizumab and the date of the first distant metastasis or the date of death (whatever the cause), whichever occurs first. |
| Number of Participants With Adverse Events (AEs) | Baseline through 100 days after last mRNA-4157 dose or up to 90 days after the last dose of pembrolizumab, whichever is later (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm) | — |
| Number of Participants Who Discontinued Due to AEs | Baseline through 100 days after last mRNA-4157 dose or up to 90 days after the last dose of pembrolizumab, whichever is later (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm) | — |
Countries
Australia, United States
Outcome results
None listed