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Clinical Trials in Australia / NCT03897881
Active, not recruiting Phase 2

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

NCT03897881 · tracked via the Priya Life Science Australia tracker
Phase
Phase 2
Started
2019-07-18
Last updated
2026-09-08

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

mRNA-4157 →Pembrolizumab →

mRNA-4157: Individualized Neoantigen Therapy

Pembrolizumab: Intravenous infusion

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

Trial sites (23)

FacilityCityRegionStatus
University of Arizona Tucson Arizona
California Pacific Medical Center Research Institute -CPMCRI San Francisco California
Angeles Clinic and Research Institute Santa Monica California
University of Colorado Cancer Center Aurora Colorado
Smilow Cancer Center at Yale New Haven Hospital New Haven Connecticut
Lombardi Cancer Center Washington D.C. District of Columbia
Orlando Health UF Health Cancer Center Orlando Florida
Northside Hospital Atlanta Georgia
UPMC Hillman Cancer Center Chicago Illinois
Massachusetts General Hospital Boston Massachusetts
Dana Farber Cancer Institute Boston Massachusetts
Washington University School of Medicine St Louis Missouri
Hackensack University Medical Center Hackensack New Jersey
NYU Langone Medical Center New York New York
Providence Cancer Institute Portland Oregon
Sarah Cannon Cancer Center Nashville Tennessee
Texas Oncology PA Dallas Texas
Melanoma Institute Australia North Sydney New South Wales
Westmead Hospital Westmead New South Wales
Princess Alexandra Hospital Woolloongabba Queensland
Affinity Clinical Research Murdoch Western Australia
One Clinical Research Perth Murdoch Western Australia
St John of God Hospital Subiaco Subiaco Western Australia

On this site

📄 Keytruda (pembrolizumab) drug profile →

More ModernaTX, Inc. trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03897881 on ClinicalTrials.gov ↗ ← All trials in Australia