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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)

NCT03897881

Active Not RecruitingPhase 2

Sponsor: ModernaTX, Inc.

Conditions: Melanoma

Interventions: mRNA-4157, Pembrolizumab

Countries: United States, Australia

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (23)

Tucson, Arizona, United States
San Francisco, California, United States
Santa Monica, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
Hackensack, New Jersey, United States
New York, New York, United States
Portland, Oregon, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
North Sydney, New South Wales, Australia
Westmead, New South Wales, Australia
Woolloongabba, Queensland, Australia
Murdoch, Western Australia, Australia
Murdoch, Western Australia, Australia
Subiaco, Western Australia, Australia