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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03897881
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

ModernaTX, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryIndustry
Overall Status Recruiting
Countries Australia, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma
Arms & Interventions

Arms

Experimental: 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.

Active Comparator: 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.

Interventions

Biological: - mRNA-4157

Personalized cancer vaccine

Biological: - Pembrolizumab

Intravenous infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you. Please note all sites listed may not currently be active in the trial. Please continue to check back for additional site locations.

University of Arizona
Recruiting | Tucson, Arizona, United States, 85719
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California Pacific Medical Center Research Institute -CPMCRI
Recruiting | San Francisco, California, United States, 94115
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Angeles Clinic and Research Institute
Recruiting | Santa Monica, California, United States, 90404
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University of Colorado Cancer Center
Recruiting | Aurora, Colorado, United States, 80045
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Smilow Cancer Center at Yale New Haven Hospital
Recruiting | New Haven, Connecticut, United States, 06520
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Lombardi Cancer Center
Recruiting | Washington, District of Columbia, United States, 20007
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Orlando Health UF Health Cancer Center
Recruiting | Orlando, Florida, United States, 32806
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UPMC Hillman Cancer Center
Recruiting | Chicago, Illinois, United States, 60637
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Massachusetts General Hospital
Recruiting | Boston, Massachusetts, United States, 02114
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Dana Farber Cancer Institute
Recruiting | Boston, Massachusetts, United States, 02115
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Washington University School of Medicine
Recruiting | Saint Louis, Missouri, United States, 63110
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Hackensack University Medical Center
Recruiting | Hackensack, New Jersey, United States, 07601
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NYU Langone Medical Center
Recruiting | New York, New York, United States, 10016
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Providence Cancer Institute
Recruiting | Portland, Oregon, United States, 97213
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Oregon Health & Science University
Recruiting | Portland, Oregon, United States, 97239
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Sarah Cannon Cancer Center
Recruiting | Nashville, Tennessee, United States, 37203
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Texas Oncology PA
Recruiting | Dallas, Texas, United States, 75246
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International Sites

Melanoma Institute Australia
Recruiting | North Sydney, New South Wales, Australia, 2060
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Westmead Hospital
Recruiting | Westmead, New South Wales, Australia, 2145
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Princess Alexandra Hospital
Recruiting | Woolloongabba, Queensland, Australia, 4102
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Affinity Clinical Research
Recruiting | Murdoch, Western Australia, Australia, 6150
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St John of God Hospital Subiaco
Recruiting | Subiaco, Western Australia, Australia, 6008
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