Back to resultsAn Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)
Primary Purpose
Melanoma
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
mRNA-4157
Pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma focused on measuring mRNA-4157, Individualized Neoantigen Therapy, INT, Pembrolizumab, Moderna
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
Sites / Locations
- University of Arizona
- California Pacific Medical Center Research Institute -CPMCRI
- Angeles Clinic and Research Institute
- University of Colorado Cancer Center
- Smilow Cancer Center at Yale New Haven HospitalRecruiting
- Lombardi Cancer CenterRecruiting
- Orlando Health UF Health Cancer CenterRecruiting
- UPMC Hillman Cancer Center
- Massachusetts General Hospital
- Dana Farber Cancer Institute
- Washington University School of Medicine
- Hackensack University Medical Center
- NYU Langone Medical Center
- Providence Cancer Institute
- Oregon Health & Science University
- Sarah Cannon Cancer CenterRecruiting
- Texas Oncology PARecruiting
- Melanoma Institute Australia
- Westmead Hospital
- Princess Alexandra Hospital
- Affinity Clinical Research
- St John of God Hospital Subiaco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
mRNA-4157 and Pembrolizumab
Pembrolizumab
Arm Description
Participants will receive up to 9 doses of mRNA-4157 (every 21 days). Participants may continue on pembrolizumab (every 21 days) until disease recurrence, unacceptable toxicity, or they undergo up to 18 total cycles (approximately 1 year of treatment), whichever is sooner.
Participants will receive pembrolizumab (every 21 days) until disease recurrence, unacceptable toxicity, or they undergo up to 18 total cycles (approximately 1 year of treatment), whichever is sooner.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Number of Participants With Adverse Events (AEs)
Number of Participants Who Discontinued Due to AEs
Full Information
NCT ID
NCT03897881
First Posted
March 29, 2019
Last Updated
May 12, 2023
Sponsor
ModernaTX, Inc.
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT03897881
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2019 (Actual)
Primary Completion Date
September 9, 2029 (Anticipated)
Study Completion Date
September 9, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
mRNA-4157, Individualized Neoantigen Therapy, INT, Pembrolizumab, Moderna
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Randomized
Enrollment
257 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mRNA-4157 and Pembrolizumab
Arm Type
Experimental
Arm Description
Participants will receive up to 9 doses of mRNA-4157 (every 21 days). Participants may continue on pembrolizumab (every 21 days) until disease recurrence, unacceptable toxicity, or they undergo up to 18 total cycles (approximately 1 year of treatment), whichever is sooner.
Arm Title
Pembrolizumab
Arm Type
Active Comparator
Arm Description
Participants will receive pembrolizumab (every 21 days) until disease recurrence, unacceptable toxicity, or they undergo up to 18 total cycles (approximately 1 year of treatment), whichever is sooner.
Intervention Type
Drug
Intervention Name(s)
mRNA-4157
Intervention Description
Individualized Neoantigen Therapy
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Intervention Description
Intravenous infusion
Primary Outcome Measure Information:
Title
Recurrence-Free Survival (RFS), Assessed Using Radiological Imaging
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.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Distant Metastasis-Free Survival (DMFS), Assessed Using Radiological Imaging
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.
Time Frame
Up to 5 years
Title
Number of Participants With Adverse Events (AEs)
Time Frame
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)
Title
Number of Participants Who Discontinued Due to AEs
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moderna Clinical Trials Support Center
Phone
1-877-777-7187
Email
clinicaltrials@modernatx.com
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
California Pacific Medical Center Research Institute -CPMCRI
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Angeles Clinic and Research Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Smilow Cancer Center at Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Weiss, MD
Phone
203-785-6378
Email
sarah.weiss.sw842@yale.edu
Facility Name
Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoffrey Gibney, MD
Phone
813-745-3437
Email
geoffrey.t.gibney@gunet.georgetown.edu
Facility Name
Orlando Health UF Health Cancer Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sajeve Thomas
Phone
954-663-7551
Email
Sajeve.thomas@orlandohealth.com
Facility Name
UPMC Hillman Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Providence Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Sarah Cannon Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meredith McKean, MD
Phone
615-329-7274
Email
mmckean@tnonc.com
Facility Name
Texas Oncology PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Cowey, MD
Phone
214-370-1000
Email
lance.cowey@usoncology.com
Facility Name
Melanoma Institute Australia
City
North Sydney
State/Province
New South Wales
ZIP/Postal Code
2060
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Affinity Clinical Research
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
St John of God Hospital Subiaco
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)
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