RWF_mRNA-4157-P201

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 (KEYNOTE- 942)

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.

Inclusion Criteria:
• 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
• Normal organ and marrow function reported at screening

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 melamonas. Radiotherapy after lymph node dissection is permitted)
• 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
• Active infection requiring treatment
Phase II
NCT03897881
Oncology
Cutaneous (skin)
Matthew Taylor, M.D.
ModernaTX, Inc.
Chris Fountain
  • Providence Cancer Institute Franz Clinic