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Phase II

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)

  • Study HIC#:2000025461
  • Last Updated:06/16/2020

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.

  • Start Date10/12/2019
  • End Date12/30/2021

Trial Purpose and Description

Primary Outcome Measures  :

  1. Recurrence free survival (RFS) [ Time Frame: Up to 3 years ]RFS is defined as the time between the date of first dose of pembrolizumab and the date of recurrence (local, regional, or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.

Secondary Outcome Measures  :

  1. Distant metastasis-free survival (DMFS) [ Time Frame: Up to 3 years ]DMFS is defined as the time between the date of first dose of pembrolizumab and the date of the first distant metastasis or the date of death (whatever the cause), whichever occurs first.
  2. Incidence and Severity of Adverse Events (AEs) [ Time Frame: Baseline through 90 days after last pembrolizumab dose ]According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
  3. Discontinuations due to AEs [ Time Frame: Baseline through 90 days after last pembrolizumab dose ]According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
  4. Overall survival [ Time Frame: Up to 3 years ]OS is defined as the time between the date of first dose of pembrolizumab and the date of death due to any cause

Eligibility Criteria

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
  • ECOG Performance Status 0 or 1
  • 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)
  • 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 HIV
  • Known active hepatitis B or C
  • Active infection requiring treatment

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