Clinical trial NCT03897881: An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Melanoma
Keywords: mRNA-4157
Individualized Neoantigen Therapy
INT
Pembrolizumab
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2019-04-01
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Key Inclusion Criteria:

* Resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence
* Complete resection within 13 weeks prior to the first dose of pembrolizumab
* Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases
* Has an formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Normal organ and marrow function reported at screening

Key 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 melanomas. 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 human immunodeficiency virus (HIV)
* Known active hepatitis B or C
* Active infection requiring treatment

Primary outcomes:
measure: Recurrence-Free Survival (RFS), Assessed Using Radiological Imaging
timeFrame: Up to 7 years
Secondary outcomes:
measure: Distant Metastasis-Free Survival (DMFS), Assessed Using Radiological Imaging
timeFrame: Up to 7 years
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline through 100 days after last mRNA-4157 dose or up to 90 days after the last dose of pembrolizumab, whichever is later (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm)
measure: Number of Participants Who Discontinued Due to AEs
timeFrame: Baseline through 100 days after last mRNA-4157 dose or up to 90 days after the last dose of pembrolizumab, whichever is later (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: San Francisco
country: United States
facility: California Pacific Medical Center Research Institute -CPMCRI
state: California
city: Santa Monica
country: United States
facility: Angeles Clinic and Research Institute
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: New Haven
country: United States
facility: Smilow Cancer Center at Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: Lombardi Cancer Center
state: District of Columbia
city: Orlando
country: United States
facility: Orlando Health UF Health Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Chicago
country: United States
facility: UPMC Hillman Cancer Center
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Portland
country: United States
facility: Providence Cancer Institute
state: Oregon
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology PA
state: Texas
city: North Sydney
country: Australia
facility: Melanoma Institute Australia
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Murdoch
country: Australia
facility: Affinity Clinical Research
state: Western Australia
city: Subiaco
country: Australia
facility: St John of God Hospital Subiaco
state: Western Australia
Study officials:
References: