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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| ClinicalTrials.gov Identifier: NCT03897881 |
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Recruitment Status :
Recruiting
First Posted : April 1, 2019
Last Update Posted : December 13, 2023
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Sponsor:
ModernaTX, Inc.
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
ModernaTX, Inc.
- Study Details
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Melanoma | Drug: mRNA-4157 Biological: Pembrolizumab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 257 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 : | September 9, 2029 |
| Estimated Study Completion Date : | September 9, 2029 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Melanoma
MedlinePlus related topics:
Melanoma
Drug Information
available for:
Pembrolizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: mRNA-4157 and Pembrolizumab
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.
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Drug: mRNA-4157
Individualized Neoantigen Therapy Biological: Pembrolizumab Intravenous infusion |
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Active Comparator: Pembrolizumab
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.
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Biological: Pembrolizumab
Intravenous infusion |
Primary Outcome Measures :
- Recurrence-Free Survival (RFS), Assessed Using Radiological Imaging [ Time Frame: Up to 5 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.
Secondary Outcome Measures :
- Distant Metastasis-Free Survival (DMFS), Assessed Using Radiological Imaging [ Time Frame: Up to 5 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.
- 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) ]
- 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) ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
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
Contacts
| Contact: Moderna Clinical Trials Support Center | 1-877-777-7187 | clinicaltrials@modernatx.com |
Locations
Show 21 study locations
Sponsors and Collaborators
ModernaTX, Inc.
Merck Sharp & Dohme LLC
| 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: | December 13, 2023 |
| Last Verified: | December 2023 |
| 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 |
Keywords provided by ModernaTX, Inc.:
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mRNA-4157 Individualized Neoantigen Therapy INT Pembrolizumab Moderna |
Additional relevant MeSH terms:
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Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
Skin Neoplasms Neoplasms by Site Skin Diseases Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |