MelanomaPhase 2NCT03897881
An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)
A Phase 2 study testing mRNA-4157 and Pembrolizumab in people with Melanoma, run by ModernaTX, Inc. at 23 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- mRNA-4157 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 18 Jul 2019to 21 Nov 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States17 sites
Northside Hospital
Atlanta, Georgia, 30342
University of Colorado Cancer Center
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
UPMC Hillman Cancer Center
Chicago, Illinois, 60637
Texas Oncology PA
Dallas, Texas, 75246
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
Smilow Cancer Center at Yale New Haven Hospital
New Haven, Connecticut, 06520
NYU Langone Medical Center
New York, New York, 10016
Orlando Health UF Health Cancer Center
Orlando, Florida, 32806
Providence Cancer Institute
Portland, Oregon, 97213
California Pacific Medical Center Research Institute -CPMCRI
San Francisco, California, 94115
Angeles Clinic and Research Institute
Santa Monica, California, 90404
Washington University School of Medicine
St Louis, Missouri, 63110
University of Arizona
Tucson, Arizona, 85719
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
Australia6 sites
Affinity Clinical Research
Murdoch, Western Australia, 6150
One Clinical Research Perth
Murdoch, Western Australia, 6150
Melanoma Institute Australia
North Sydney, New South Wales, 2060
St John of God Hospital Subiaco
Subiaco, Western Australia, 6008
Westmead Hospital
Westmead, New South Wales, 2145
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
About this study
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)
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.
- Conditions
- Melanoma
- Being tested
- mRNA-4157, Pembrolizumab
- Keywords
- mRNA-4157, Individualized Neoantigen Therapy, INT, Pembrolizumab, Moderna
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-4157Drug
Individualized Neoantigen Therapy
PembrolizumabBiological
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| mRNA-4157 and Pembrolizumab | Experimental | 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. Receives: Drug: mRNA-4157; Biological: Pembrolizumab |
| Pembrolizumab | Active comparator | 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. Receives: Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 years
Secondary outcomes (3)
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.
Measured: Up to 7 years
Number of Participants With Adverse Events (AEs)
Measured: Baseline through 100 days after last mRNA-4157 dose or up to 90 days after the last dose of pembrolizumab, whichever is later (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm)
Number of Participants Who Discontinued Due to AEs
Measured: Baseline through 100 days after last mRNA-4157 dose or up to 90 days after the last dose of pembrolizumab, whichever is later (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start18 Jul 2019
- Primary completion21 Nov 2032 (estimated)
- Study completion21 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897881
- Sponsor's protocol ID
- mRNA-4157-P201
- Status last verified
- Aug 2026
- First submitted
- 29 Mar 2019
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khattak A, Carlino MS, Meniawy T, Ansstas G, Taylor MH, Kim KB, McKean M, Long GV, Sullivan RJ, Faries M, Tran TT, Cowey CL, Pecora A, Medina T, Atkinson V, Krepler C, Jemielita T, Mao H, Chow J, Ojalvo LS, Mehnert JM; KEYNOTE-942 Investigators. Intismeran Autogene Plus Pembrolizumab Versus Pembrolizumab Alone in High-Risk Resected Melanoma: 5-Year Update of the Randomized Phase IIb KEYNOTE-942 Study. J Clin Oncol. 2026 Jun 1:JCO2600835. doi: 10.1200/JCO-26-00835. Online ahead of print.
PubMed 42223134Weber JS, Carlino MS, Khattak A, Meniawy T, Ansstas G, Taylor MH, Kim KB, McKean M, Long GV, Sullivan RJ, Faries M, Tran TT, Cowey CL, Pecora A, Shaheen M, Segar J, Medina T, Atkinson V, Gibney GT, Luke JJ, Thomas S, Buchbinder EI, Healy JA, Huang M, Morrissey M, Feldman I, Sehgal V, Robert-Tissot C, Hou P, Zhu L, Brown M, Aanur P, Meehan RS, Zaks T. Individualised neoantigen therapy mRNA-4157 (V940) plus pembrolizumab versus pembrolizumab monotherapy in resected melanoma (KEYNOTE-942): a randomised, phase 2b study. Lancet. 2024 Feb 17;403(10427):632-644. doi: 10.1016/S0140-6736(23)02268-7. Epub 2024 Jan 18.
PubMed 38246194
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03897881
- Acronym / sponsor ID
- mRNA-4157-P201
- Conditions
- Melanoma
- Keywords
- mRNA-4157, Individualized Neoantigen Therapy, INT, Pembrolizumab, Moderna
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 267 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- 21 Nov 2032 (estimated)
- Study completion
- 21 Nov 2032 (estimated)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mRNA-4157 and Pembrolizumab | Experimental | Drug: mRNA-4157, Biological: PembrolizumabParticipants 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. |
| Pembrolizumab | Active comparator | Biological: PembrolizumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-4157Individualized Neoantigen Therapy | Drug | mRNA-4157 and Pembrolizumab |
| PembrolizumabIntravenous infusion | Biological | Pembrolizumab, mRNA-4157 and Pembrolizumab |
Primary outcome
Recurrence-Free Survival (RFS), Assessed Using Radiological Imaging
Time frame: Up to 7 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.
3 secondary outcomes
Distant Metastasis-Free Survival (DMFS), Assessed Using Radiological Imaging
Time frame: Up to 7 years
Number of Participants With Adverse Events (AEs)
Time frame: Baseline through 100 days after last mRNA-4157 dose or up to 90 days after the last dose of pembrolizumab, whichever is later (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm)
Number of Participants Who Discontinued Due to AEs
Time frame: Baseline through 100 days after last mRNA-4157 dose or up to 90 days after the last dose of pembrolizumab, whichever is later (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Derived from this study: PubMed 42223134Khattak A, Carlino MS, Meniawy T, Ansstas G, Taylor MH, Kim KB, McKean M, Long GV, Sullivan RJ, Faries M, Tran TT, Cowey CL, Pecora A, Medina T, Atkinson V, Krepler C, Jemielita T, Mao H, Chow J, Ojalvo LS, Mehnert JM; KEYNOTE-942 Investigators. Intismeran Autogene Plus Pembrolizumab Versus Pembrolizumab Alone in High-Risk Resected Melanoma: 5-Year Update of the Randomized Phase IIb KEYNOTE-942 Study. J Clin Oncol. 2026 Jun 1:JCO2600835. doi: 10.1200/JCO-26-00835. Online ahead of print.
- Derived from this study: PubMed 38246194Weber JS, Carlino MS, Khattak A, Meniawy T, Ansstas G, Taylor MH, Kim KB, McKean M, Long GV, Sullivan RJ, Faries M, Tran TT, Cowey CL, Pecora A, Shaheen M, Segar J, Medina T, Atkinson V, Gibney GT, Luke JJ, Thomas S, Buchbinder EI, Healy JA, Huang M, Morrissey M, Feldman I, Sehgal V, Robert-Tissot C, Hou P, Zhu L, Brown M, Aanur P, Meehan RS, Zaks T. Individualised neoantigen therapy mRNA-4157 (V940) plus pembrolizumab versus pembrolizumab monotherapy in resected melanoma (KEYNOTE-942): a randomised, phase 2b study. Lancet. 2024 Feb 17;403(10427):632-644. doi: 10.1016/S0140-6736(23)02268-7. Epub 2024 Jan 18.
- Individual participant dataSharing planned: No
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mRNA-4157 and Pembrolizumab in people with Melanoma, run by ModernaTX, Inc. at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-Free Survival (RFS), Assessed Using Radiological Imaging (time frame: Up to 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03897881, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.