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Personalized mRNA vaccine shows promise in fighting melanoma return

NCT ID NCT03897881

Disease control Sponsor: ModernaTX, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This phase 2 trial is testing whether adding a personalized mRNA cancer vaccine (mRNA-4157) to the immunotherapy drug pembrolizumab can better prevent melanoma from coming back after surgery compared to pembrolizumab alone. The study involves 267 people with high-risk melanoma that has been completely removed. The vaccine is custom-made for each patient based on their tumor's genetic profile, aiming to train the immune system to recognize and attack any remaining cancer cells.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
personalized mRNA cancer vaccine (mRNA-4157) and pembrolizumab
What this could lead to
If successful, this could offer a more effective way to prevent melanoma from coming back after surgery, potentially improving long-term survival.
What could go wrong
This is an early phase 2 trial with only 267 participants, so results may not apply to everyone. The vaccine is personalized, which makes it complex and expensive, and there is no guarantee it will outperform standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

267 people

The number who actually took part.

Started

Jul 2019

Expected to finish

Nov 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma

Contacts and locations

Locations

  • Affinity Clinical Research

    Murdoch, Western Australia, 6150, Australia

  • Angeles Clinic and Research Institute

    Santa Monica, California, 90404, United States

  • California Pacific Medical Center Research Institute -CPMCRI

    San Francisco, California, 94115, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Melanoma Institute Australia

    North Sydney, New South Wales, 2060, Australia

  • NYU Langone Medical Center

    New York, New York, 10016, United States

  • Northside Hospital

    Atlanta, Georgia, 30342, United States

  • One Clinical Research Perth

    Murdoch, Western Australia, 6150, Australia

  • Orlando Health UF Health Cancer Center

    Orlando, Florida, 32806, United States

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Providence Cancer Institute

    Portland, Oregon, 97213, United States

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203, United States

  • Smilow Cancer Center at Yale New Haven Hospital

    New Haven, Connecticut, 06520, United States

  • St John of God Hospital Subiaco

    Subiaco, Western Australia, 6008, Australia

  • Texas Oncology PA

    Dallas, Texas, 75246, United States

  • UPMC Hillman Cancer Center

    Chicago, Illinois, 60637, United States

  • University of Arizona

    Tucson, Arizona, 85719, United States

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

More trials for these conditions

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