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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
ModernaTX, Inc.
Study ID
NCT03897881
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • mRNA-4157 — DRUG
    Individualized Neoantigen Therapy
  • Pembrolizumab — BIOLOGICAL
    Intravenous infusion

Study Details

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.

Key Dates

First listed
Apr 1, 2019
Start date
Jul 18, 2019
Status verified
Nov 2025
Primary completion
Nov 30, 2032
Completion
Nov 30, 2032

Study Design

Enrollment
267 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Recurrence-Free Survival (RFS), Assessed Using Radiological Imaging [ Time Frame: Up to 7 years ]

Locations (17)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85719-
California Pacific Medical Center Research Institute -CPMCRISan FranciscoCalifornia94115-
Angeles Clinic and Research InstituteSanta MonicaCalifornia90404-
University of Colorado Cancer CenterAuroraColorado80045-
Smilow Cancer Center at Yale New Haven HospitalNew HavenConnecticut06520-
Lombardi Cancer CenterWashington D.C.District of Columbia20007-
Orlando Health UF Health Cancer CenterOrlandoFlorida32806-
Northside HospitalAtlantaGeorgia30342-
UPMC Hillman Cancer CenterChicagoIllinois60637-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
Washington University School of MedicineSt LouisMissouri63110-
Hackensack University Medical CenterHackensackNew Jersey07601-
NYU Langone Medical CenterNew YorkNew York10016-
Providence Cancer InstitutePortlandOregon97213-
Sarah Cannon Cancer CenterNashvilleTennessee37203-
Texas Oncology PADallasTexas75246-

Find similar trials in Tucson, AZ

Nationwide
Melanoma trialsOncology trialsSkin cancer trialsDermatology trials
By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of Arizona· Tucson, AZCalifornia Pacific Medical Center Research Institute -CPMCRI· San Francisco, CAAngeles Clinic and Research Institute· Santa Monica, CAUniversity of Colorado Cancer Center· Aurora, COSmilow Cancer Center at Yale New Haven Hospital· New Haven, CTLombardi Cancer Center· Washington D.C., DC

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