An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Patients With High-Risk Melanoma (KEYNOTE-942)
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ClinicalTrials.gov Identifier: NCT03897881 |
Recruitment Status :
Recruiting
First Posted : April 1, 2019
Last Update Posted : March 24, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Melanoma | Biological: mRNA-4157 Biological: Pembrolizumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Masking Description: | Open Label |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | July 18, 2019 |
Estimated Primary Completion Date : | June 30, 2022 |
Estimated Study Completion Date : | June 30, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Combination treatment arm
mRNA-4157 and pembrolizumab
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Biological: mRNA-4157
Personalized cancer vaccine Biological: Pembrolizumab Intravenous infusion |
Active Comparator: Control treatment arm
Pembrolizumab only
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Biological: Pembrolizumab
Intravenous infusion |
- Recurrence free survival (RFS) [ Time Frame: Up to 3 years ]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.
- Distant metastasis-free survival (DMFS) [ Time Frame: Up to 3 years ]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.
- Incidence and Severity of Adverse Events (AEs) [ Time Frame: Baseline through 90 days after last pembrolizumab dose ]According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
- Discontinuations due to AEs [ Time Frame: Baseline through 90 days after last pembrolizumab dose ]According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
- Overall survival [ Time Frame: Up to 3 years ]OS is defined as the time between the date of first dose of pembrolizumab and the date of death due to any cause

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897881
Contact: Moderna Clinical Trials | 855-663-6762 | clinicaltrials@modernatx.com |

Responsible Party: | ModernaTX, Inc. |
ClinicalTrials.gov Identifier: | NCT03897881 |
Other Study ID Numbers: |
mRNA-4157-P201 |
First Posted: | April 1, 2019 Key Record Dates |
Last Update Posted: | March 24, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
mRNA-4157 Personalized cancer vaccine PCV Pembrolizumab Moderna |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents |