An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Patients With High-Risk Melanoma (KEYNOTE-942)
A Phase 2 Randomized Study of Adjuvant Immunotherapy With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab Versus Pembrolizumab Alone After Complete Resection of High-Risk Melanoma
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Clinical Trial Information
Trial Contact: Caldwell, Chloe M; Rodriguez Saavedra, Carlis M
Trial Phone: (321)841.1107 ; 321.841.6764
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IRB No: S20.158.09
Protocol Abbrev: MODERNA-mRNA-4157-P201
Principal Investigator: Sajeve Samuel Thomas, MD
Phase: Drug: Phase II
Age Group: Adult
Secondary Protocol No: mR-4157-P201
Treatment: Biological: mRNA-4157 Biological: Pembrolizumab
Therapies Involved: Oncology: 2nd line
ClinicalTrials.gov ID: NCT03897881
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Objective
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 patients with complete resection of cutaneous melanoma and a high risk of recurrence.
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Key Eligibility
• Resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence
• Complete resection within 13 weeks before study enrollment
• Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases
• Has an FFPE tumor sample available suitable for sequencing
• ECOG Performance Status 0 or 1
• Normal organ and marrow function reported at screening
