Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03897881
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : August 12, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
ModernaTX, Inc.

Brief 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 patients with complete resection of cutaneous melanoma and a high risk of recurrence.

Condition or disease Intervention/treatment Phase
Melanoma Biological: mRNA-4157 Biological: Pembrolizumab Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized Study of Adjuvant Immunotherapy With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab Versus Pembrolizumab Alone After Complete Resection of High-Risk Melanoma (KEYNOTE- 942)
Actual Study Start Date : July 18, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Combination treatment arm
mRNA-4157 and pembrolizumab
Biological: mRNA-4157
Personalized cancer vaccine

Biological: Pembrolizumab
Intravenous infusion

Active Comparator: Control treatment arm
Pembrolizumab only
Biological: Pembrolizumab
Intravenous infusion




Primary Outcome Measures :
  1. Recurrence free survival (RFS) [ Time Frame: Up to 3 years ]
    RFS is defined as the time between the date of first dose of pembrolizumab and the date of recurrence (local, regional, or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.


Secondary Outcome Measures :
  1. Distant metastasis-free survival (DMFS) [ Time Frame: Up to 3 years ]
    DMFS is defined as the time between the date of first dose of pembrolizumab and the date of the first distant metastasis or the date of death (whatever the cause), whichever occurs first.

  2. Incidence and Severity of Adverse Events (AEs) [ Time Frame: Baseline through 90 days after last pembrolizumab dose ]
    According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)

  3. Discontinuations due to AEs [ Time Frame: Baseline through 90 days after last pembrolizumab dose ]
    According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)

  4. Overall survival [ Time Frame: Up to 3 years ]
    OS is defined as the time between the date of first dose of pembrolizumab and the date of death due to any cause



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence
  • Complete resection within 13 weeks before study enrollment
  • Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases
  • Has an FFPE tumor sample available suitable for sequencing
  • ECOG Performance Status 0 or 1
  • Normal organ and marrow function reported at screening

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 melamonas. 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 HIV
  • Known active hepatitis B or C
  • Active infection requiring treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897881


Contacts
Layout table for location contacts
Contact: Moderna Clinical Trials 855-663-6762 clinicaltrials@modernatx.com

Locations
Layout table for location information
United States, California
UC San Diego Moores Cancer Center Not yet recruiting
La Jolla, California, United States, 92093
Contact: Gregory Daniels, MD    858-534-3804    gdaniels@ucsd.edu   
California Pacific Medical Center Research Institute -CPMCRI Not yet recruiting
San Francisco, California, United States, 94115
Contact: Kevin Kim, MD    415-885-8600    kimkb@sutterhealth.org   
Angeles Clinic and Research Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Mark Faries, MD    310-582-7020    mfaries@theangelesclinic.org   
United States, Colorado
University of Colorado Cancer Center Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Karl Lewis, MD    720-848-0637    karl.lewis@ucdenver.edu   
United States, Connecticut
Smilow Cancer Center at Yale New Haven Hospital Not yet recruiting
New Haven, Connecticut, United States, 06520
Contact: Sarah Weiss, MD    203-785-6378    sarah.weiss.sw842@yale.edu   
United States, District of Columbia
Lombardi Cancer Center Not yet recruiting
Washington, District of Columbia, United States, 20007
Contact: Geoffrey Gibney, MD    813-745-3437    geoffrey.t.gibney@gunet.georgetown.edu   
United States, Florida
SCRI Florida Cancer Specialists East Not yet recruiting
West Palm Beach, Florida, United States, 33401
Contact: Neal Rothschild, MD    561-366-4131    nrothschild@flcancer.com   
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Ryan Sullivan, MD    617-632-5470    rsullivan7@mgh.harvard.edu   
United States, Missouri
Washington University School of Medicine Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Leonel Hernandez Aya, MD    314-747-7510    lhernand@dom.wustl.edu   
United States, New Jersey
Hackensack University Medical Center Not yet recruiting
Hackensack, New Jersey, United States, 07601
Contact: Andrew Pecora, MD    551-996-5814    andrew.pecora@hackensackmeridian.org   
United States, New York
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Jeffrey Weber, MD    212-731-6262    jeffrey.weber@nyumc.org   
United States, Oregon
Oregone Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Matthew Taylor, MD    503-494-8534    taylmatt@ohsu.edu   
United States, Tennessee
Sarah Cannon Cancer Center Not yet recruiting
Nashville, Tennessee, United States, 37203
Contact: Meredith McKean, MD    615-329-7274    mmckean@tnonc.com   
United States, Texas
Texas Oncology PA Not yet recruiting
Dallas, Texas, United States, 75246
Contact: Charles Cowey, MD    214-370-1000    lance.cowey@usoncology.com   
Australia, New South Wales
Westmead Hospital Not yet recruiting
Westmead, New South Wales, Australia, 2145
Contact: Matteo Carlino, MD    +61 2 9845 5200    matteo.carlino@sydney.edu.au   
Australia, Queensland
Princess Alexandra Hospital Not yet recruiting
Woolloongabba, Queensland, Australia, 4102
Contact: Victoria Atkinson, MD    +61 7 3176 3091    victoria.atkinson@health.qld.gov.au   
Australia, Western Australia
St John of God Hospital Subiaco Recruiting
Subiaco, Western Australia, Australia, 6008
Contact: Adnan Khattak, MD    +61 8 6102 3640    Muhammad.Khattak@health.wa.gov.au   
Sponsors and Collaborators
ModernaTX, Inc.
Merck Sharp & Dohme Corp.

Layout table for additonal information
Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT03897881     History of Changes
Other Study ID Numbers: mRNA-4157-P201
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ModernaTX, Inc.:
mRNA-4157
Personalized cancer vaccine
PCV
Pembrolizumab
Moderna

Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Pembrolizumab
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents