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

Status
Active
Cancer Type
Melanoma
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03897881
Protocol IDs
mRNA-4157-P201 (primary)
NCI-2019-04957
Study Sponsor
ModernaTX, Inc.

Summary

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

  1. Resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence
  2. Complete resection within 13 weeks prior to the first dose of pembrolizumab
  3. Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases
  4. Has an formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  6. Normal organ and marrow function reported at screening Key

Treatment Sites in Georgia

Northside Hospital Cancer Institute


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.