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

Sponsor: ModernaTX, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03897881

Patient View

This study evaluates the efficacy of mRNA-4157 combined with pembrolizumab as adjuvant therapy in high-risk melanoma patients post-resection. Eligible participants must have resectable melanoma, be disease-free post-surgery, and meet specific health criteria. Interventions include mRNA-4157, an individualized neoantigen therapy, and pembrolizumab, administered via intravenous infusion.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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

Get This Program In Your Inbox

You can sign up and apply your patients for this program.