An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)
NCT ID: NCT03897881
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
267 participants
INTERVENTIONAL
2019-07-18
2032-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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mRNA-4157 and Pembrolizumab
Participants will receive up to 9 doses of mRNA-4157 (every 21 days). Participants may continue on pembrolizumab (every 21 days) until disease recurrence, unacceptable toxicity, or they undergo up to 18 total cycles (approximately 1 year of treatment), whichever is sooner.
mRNA-4157
Individualized Neoantigen Therapy
Pembrolizumab
Intravenous infusion
Pembrolizumab
Participants will receive pembrolizumab (every 21 days) until disease recurrence, unacceptable toxicity, or they undergo up to 18 total cycles (approximately 1 year of treatment), whichever is sooner.
Pembrolizumab
Intravenous infusion
Interventions
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mRNA-4157
Individualized Neoantigen Therapy
Pembrolizumab
Intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Arizona
Tucson, Arizona, United States
California Pacific Medical Center Research Institute -CPMCRI
San Francisco, California, United States
Angeles Clinic and Research Institute
Santa Monica, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Smilow Cancer Center at Yale New Haven Hospital
New Haven, Connecticut, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Orlando Health UF Health Cancer Center
Orlando, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
UPMC Hillman Cancer Center
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
NYU Langone Medical Center
New York, New York, United States
Providence Cancer Institute
Portland, Oregon, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Texas Oncology PA
Dallas, Texas, United States
Melanoma Institute Australia
North Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Affinity Clinical Research
Murdoch, Western Australia, Australia
One Clinical Research Perth
Murdoch, Western Australia, Australia
St John of God Hospital Subiaco
Subiaco, Western Australia, Australia
Countries
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References
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Weber JS, Carlino MS, Khattak A, Meniawy T, Ansstas G, Taylor MH, Kim KB, McKean M, Long GV, Sullivan RJ, Faries M, Tran TT, Cowey CL, Pecora A, Shaheen M, Segar J, Medina T, Atkinson V, Gibney GT, Luke JJ, Thomas S, Buchbinder EI, Healy JA, Huang M, Morrissey M, Feldman I, Sehgal V, Robert-Tissot C, Hou P, Zhu L, Brown M, Aanur P, Meehan RS, Zaks T. Individualised neoantigen therapy mRNA-4157 (V940) plus pembrolizumab versus pembrolizumab monotherapy in resected melanoma (KEYNOTE-942): a randomised, phase 2b study. Lancet. 2024 Feb 17;403(10427):632-644. doi: 10.1016/S0140-6736(23)02268-7. Epub 2024 Jan 18.
Other Identifiers
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mRNA-4157-P201
Identifier Type: -
Identifier Source: org_study_id
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