An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)

• Status: Recruiting
• Trial end date: 2029-09-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ModernaTX, Inc.
• Collaborator: Merck Sharp & Dohme LLC
• Treatments: Pembrolizumab

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