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

Melanoma Clinical Trial

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT03897881
• Other study ID #: mRNA-4157-P201
• Status: Recruiting
• Phase: Phase 2
• Start date: July 18, 2019
• Est. completion date: September 9, 2029

Study information

• Verified date: May 2024
• Source: ModernaTX, Inc.
• Contact: Moderna Clinical Trials Support Center
• Phone: 1-877-777-7187
• Email: clinicaltrials[@]modernatx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 267
• Est. completion date: September 9, 2029
• Est. primary completion date: September 9, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• mRNA-4157
Individualized Neoantigen Therapy

Biological:
• Pembrolizumab
Intravenous infusion

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
ModernaTX, Inc.	Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-Free Survival (RFS), Assessed Using Radiological Imaging	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.	Up to 5 years
Secondary	Distant Metastasis-Free Survival (DMFS), Assessed Using Radiological Imaging	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.	Up to 5 years
Secondary	Number of Participants With Adverse Events (AEs)		Baseline through 100 days after last mRNA-4157 dose (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm) (up to a total of 5 years for both arms)
Secondary	Number of Participants Who Discontinued Due to AEs		Baseline through 100 days after last mRNA-4157 dose (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm) (up to a total of 5 years for both arms)