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 (mRNA-4157-P201)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
  • Age: Between 18 Year(s) - 100 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Has a diagnosis of resectable cutaneous melanoma (per American Joint Committee on Cancer [AJCC], 8th edition) with histologically confirmed cutaneous melanoma that was metastatic to a lymph node at one of the following stages: a)Stage IIIB, only if relapsed within 3 months of initial surgery of curative intent. That is, the patient must have relapsed within 3 months of their first surgery of curative intent and subsequently had a second surgery of curative intent before entering this study (as such, newly diagnosed Stage IIIB patients are not eligible). b) Stage IIIC, Stage IIID, Stage IV. Melanoma with unknown origin of the primary is eligible. 2) Has an FFPE tumor sample available (eg, from their prior surgery) that is suitable for the NGS required for this study.

You may not be eligible for this study if the following are true:

  • 1) Has a history of a hematologic or primary solid tumor malignancy (other than cutaneous melanoma under study), unless there has been no evidence of that disease for at least 5 years prior to study entry. 2) Has an active autoimmune disease (excluding diabetes mellitus and/or vitiligo) that has required systemic treatment in the past 2 years prior to consent (ie, treatment with disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted. 3) Has a history of interstitial lung disease.

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