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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
Open Label

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Lombardi Cancer Center
Washington, District of Columbia 20007
Contact:
Geoffrey Gibney, MD
813-745-3437
geoffrey.t.gibney@gunet.georgetown.edu

More Details

Status
Recruiting
Sponsor
ModernaTX, Inc.

Study Contact

Moderna Clinical Trials
855-663-6762
clinicaltrials@modernatx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.