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RecruitingLast updated: 28 March 2024

KEYNOTE-942: This study is assessing whether receiving a personalised cancer vaccine plus immunotherapy after surgery is more effective compared to receiving immunotherapy alone in people who have had their melanoma completely removed and are at a high risk of recurrenceA 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

Clinical summary


This trial is treating patients with cutaneous melanoma that has been removed by surgery and are at a high risk of recurrence


Skin Cancers Skin





Trial Acronym


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Trial Identifiers

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Trial sponsor

ModernaTX, Inc.

Scientific Title

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



  • 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


  • 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


  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has not spread to other parts of the body.


  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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Information for family, friends and carers

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Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.


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