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

Launched by MODERNATX, INC. · Mar 29, 2019

Keywords

ClinConnect Summary

This clinical trial, called KEYNOTE-942, is studying a new treatment approach for patients with high-risk melanoma, a type of skin cancer. Researchers want to find out if combining a personalized cancer vaccine called mRNA-4157 with an existing medication, pembrolizumab, can help prevent the cancer from coming back after surgery. This study is for adults aged 65 to 74 who have had their melanoma completely removed and are currently cancer-free, but are at a higher risk of recurrence. Participants need to have a specific tumor sample available for testing and should be in good overall health.

If eligible and you choose to participate, you will receive either the combination of the cancer vaccine and pembrolizumab or pembrolizumab alone. The goal is to see which treatment works better in keeping melanoma from returning. It’s important to note that there are specific health criteria that need to be met to ensure safety, such as not having active infections or certain other medical conditions. The trial is currently recruiting participants, and this could be an opportunity to contribute to important cancer research while potentially benefiting from a new treatment.

Gender

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Eligibility 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