MRNA vaccine technology takes on advanced cancers

NCT ID NCT05533697

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

First seen Jun 24, 2026 · Last updated Jul 15, 2026 · Updated 3 times

Summary

This study tests an experimental mRNA therapy called mRNA-4359, given alone or with standard immunotherapy drugs, in people with advanced solid tumors (like melanoma, lung cancer, or colorectal cancer). The main goals are to find a safe dose and see if the treatment can shrink tumors. About 361 participants will take part across multiple study arms.

What this could mean

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

Active substance: mRNA-4359 (a messenger RNA therapy) given alone or with pembrolizumab, ipilimumab, or nivolumab (immune checkpoint inhibitors)
What this could lead to: If it works, this could point toward a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
What could go wrong: This is an early-phase trial (Phase 1/2) focused on safety and dosing, so it is not yet known if the treatment will shrink tumors or improve survival. Side effects from the mRNA therapy or the immune drugs could be serious.

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Conditions

The condition(s) this trial relates to.

basal cell carcinoma colorectal cancer cutaneous melanoma head and neck squamous cell carcinoma neoplasm Neoplasm Metastasis non-invasive bladder urothelial carcinoma non-small cell lung carcinoma Recurrence triple-negative breast carcinoma

As listed by the trial registrant

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

ADVANCED SOLID TUMORS

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

A.O. Santa Maria della Misericordia
RECRUITING

Udine, Perugia, 6132, Italy
Austin Hospital
RECRUITING

Melbourne, Victoria, 3084, Australia
Beatson West of Scotland Cancer Centre
RECRUITING

Glasgow, Scotland, G12 0YN, United Kingdom
Carolina BioOncology Institute
COMPLETED

Huntersville, North Carolina, 28078, United States
Churchill Hospital
RECRUITING

Oxford, OX3 7LE, United Kingdom
Dana Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02215, United States
George Washington University
RECRUITING

Washington D.C., District of Columbia, 20037, United States
Guy's and St. Thomas' NHS Foundation Trust
RECRUITING

London, SE1 7EH, United Kingdom
Henry Ford Hospital
RECRUITING

Detroit, Michigan, 48202, United States
Hospital Clinic De Barcelona - Oncología Médica
RECRUITING

Barcelona, 8036, Spain
Hospital Regional Universitario de Málaga Parent Org
RECRUITING

Málaga, 29010, Spain
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, 28041, Spain
Imperial College London
RECRUITING

London, W12 0HS, United Kingdom
John Theurer Cancer Center
RECRUITING

Hackensack, New Jersey, 07601, United States
Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
RECRUITING

Preston, Lancashire, PR2 9HT, United Kingdom
Lungenfachklinik Immenhausen - Thoracic Oncology
RECRUITING

Immenhausen, Hesse, 34376, Germany
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Melanoma Institute Australia
RECRUITING

Wollstonecraft, New South Wales, 2065, Australia
Memorial Sloan Kettering Cancer Center - Melanoma & Immunotherapeutics
RECRUITING

New York, New York, 10065, United States
NEXT Oncology Barcelona
COMPLETED

Barcelona, 08023, Spain
NEXT Oncology Madrid
COMPLETED

Madrid, 28223, Spain
NYU Langone Health-Perlmutter Cancer Center
RECRUITING

New York, New York, 10016, United States
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie
RECRUITING

Warsaw, Masovia, 02-781, Poland
One Clinical Research
RECRUITING

Nedlands, Western Australia, 6009, Australia
Oregon Health & Science University
COMPLETED

Portland, Oregon, 97239, United States
Orlando Health UF Health Cancer Center
RECRUITING

Orlando, Florida, 32806, United States
Queen Elizabeth Hospital Birmingham
RECRUITING

Birmingham, B15 2GW, United Kingdom
Sara Cannon Research Institute Tennessee
RECRUITING

Nashville, Tennessee, 37203, United States
South Texas Accelerated Research Therapeutics (START) - Rioja
RECRUITING

Logroño, La Rioja, 26006, Spain
Southside Cancer Center
RECRUITING

Miranda, New South Wales, 2228, Australia
The Angeles Clinic and Research Institute
RECRUITING

Los Angeles, California, 90025, United States
The Christie NHS Foundation Trust - Cancer Research Centre
RECRUITING

Manchester, M20 4BX, United Kingdom
The University of Chicago Medicine
RECRUITING

Chicago, Illinois, 60637, United States
UCSF Helen Diller Family Comprehensive Cancer Center
RECRUITING

San Francisco, California, 94143, United States
University College London Hospitals NHS Foundation Trust
RECRUITING

London, NW1 2PG, United Kingdom
University Hospital Southampton NHS Foundation Trust
RECRUITING

Southampton, SO16 6YD, United Kingdom
University of Colorado Cancer Center
RECRUITING

Aurora, Colorado, 80045, United States
Washington University
RECRUITING

St Louis, Missouri, 63110, United States
Wollongong Hospital
RECRUITING

Wollongong, New South Wales, 2500, Australia

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