An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Patients With High-Risk Melanoma (KEYNOTE-942)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03897881 |
|
Recruitment Status :
Recruiting
First Posted : April 1, 2019
Last Update Posted : February 6, 2020
|
Sponsor:
ModernaTX, Inc.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
ModernaTX, Inc.
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 patients with complete resection of cutaneous melanoma and a high risk of recurrence.
| 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 : | December 2021 |
| Estimated Study Completion Date : | December 2023 |
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 |
|---|---|
|
Experimental: Combination treatment arm
mRNA-4157 and pembrolizumab
|
Biological: mRNA-4157
Personalized cancer vaccine Biological: Pembrolizumab Intravenous infusion |
|
Active Comparator: Control treatment arm
Pembrolizumab only
|
Biological: Pembrolizumab
Intravenous infusion |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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 | 855-663-6762 | clinicaltrials@modernatx.com |
Locations
| United States, California | |
| California Pacific Medical Center Research Institute -CPMCRI | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Kevin Kim, MD 415-885-8600 kimkb@sutterhealth.org | |
| Angeles Clinic and Research Institute | Recruiting |
| Santa Monica, California, United States, 90404 | |
| Contact: Mark Faries, MD 310-582-7020 mfaries@theangelesclinic.org | |
| United States, Colorado | |
| University of Colorado Cancer Center | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Karl Lewis, MD 720-848-0637 karl.lewis@ucdenver.edu | |
| United States, Connecticut | |
| Smilow Cancer Center at Yale New Haven Hospital | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Sarah Weiss, MD 203-785-6378 sarah.weiss.sw842@yale.edu | |
| United States, District of Columbia | |
| Lombardi Cancer Center | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Geoffrey Gibney, MD 813-745-3437 geoffrey.t.gibney@gunet.georgetown.edu | |
| United States, Florida | |
| SCRI Florida Cancer Specialists East | Recruiting |
| West Palm Beach, Florida, United States, 33401 | |
| Contact: Neal Rothschild, MD 561-366-4131 nrothschild@flcancer.com | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Not yet recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Ryan Sullivan, MD 617-632-5470 rsullivan7@mgh.harvard.edu | |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Leonel Hernandez Aya, MD 314-747-7510 lhernand@dom.wustl.edu | |
| United States, New Jersey | |
| Hackensack University Medical Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Andrew Pecora, MD 551-996-5814 andrew.pecora@hackensackmeridian.org | |
| United States, New York | |
| NYU Langone Medical Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Jeffrey Weber, MD 212-731-6262 jeffrey.weber@nyumc.org | |
| United States, Oregon | |
| Oregon Health & Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Matthew Taylor, MD 503-494-8534 taylmatt@ohsu.edu | |
| United States, Tennessee | |
| Sarah Cannon Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Meredith McKean, MD 615-329-7274 mmckean@tnonc.com | |
| United States, Texas | |
| Texas Oncology PA | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Charles Cowey, MD 214-370-1000 lance.cowey@usoncology.com | |
| Australia, New South Wales | |
| Westmead Hospital | Recruiting |
| Westmead, New South Wales, Australia, 2145 | |
| Contact: Matteo Carlino, MD +61 2 9845 5200 matteo.carlino@sydney.edu.au | |
| Australia, Queensland | |
| Princess Alexandra Hospital | Recruiting |
| Woolloongabba, Queensland, Australia, 4102 | |
| Contact: Victoria Atkinson, MD +61 7 3176 3091 victoria.atkinson@health.qld.gov.au | |
| Australia, Western Australia | |
| St John of God Hospital Subiaco | Recruiting |
| Subiaco, Western Australia, Australia, 6008 | |
| Contact: Adnan Khattak, MD +61 8 6102 3640 Muhammad.Khattak@health.wa.gov.au | |
Sponsors and Collaborators
ModernaTX, Inc.
Merck Sharp & Dohme Corp.
| 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: | February 6, 2020 |
| Last Verified: | February 2020 |
| 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.:
|
mRNA-4157 Personalized cancer vaccine PCV Pembrolizumab Moderna |
Additional relevant MeSH terms:
|
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 |