Clinical Trials /

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

NCT03897881

Description:

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.

Related Conditions:
  • Cutaneous Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: mRNA-4157-P201
  • NCT ID: NCT03897881

Conditions

  • Melanoma

Interventions

DrugSynonymsArms
mRNA-4157Combination treatment arm
PembrolizumabCombination treatment arm

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

Trial Arms

NameTypeDescriptionInterventions
Combination treatment armExperimentalmRNA-4157 and pembrolizumab
  • mRNA-4157
  • Pembrolizumab
Control treatment armActive ComparatorPembrolizumab only
  • Pembrolizumab

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Recurrence free survival (RFS)
Time Frame:Up to 3 years
Safety Issue:
Description: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

Measure:Distant metastasis-free survival (DMFS)
Time Frame:Up to 3 years
Safety Issue:
Description: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.
Measure:Incidence and Severity of Adverse Events (AEs)
Time Frame:Baseline through 90 days after last pembrolizumab dose
Safety Issue:
Description:According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Measure:Discontinuations due to AEs
Time Frame:Baseline through 90 days after last pembrolizumab dose
Safety Issue:
Description:According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Measure:Overall survival
Time Frame:Up to 3 years
Safety Issue:
Description:OS is defined as the time between the date of first dose of pembrolizumab and the date of death due to any cause

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:ModernaTX, Inc.

Trial Keywords

  • mRNA-4157
  • Personalized cancer vaccine
  • PCV
  • Pembrolizumab
  • Moderna

Last Updated