Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Show Show 17 study locations
Sponsors and Collaborators
ModernaTX, Inc.
Merck Sharp & Dohme Corp.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT03897881    
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