Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors

ClinicalTrials.gov ID: NCT05533697

Public ClinicalTrials.gov record NCT05533697. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 1:56 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary goal of this study is to assess the safety and tolerability of mRNA-4359 administered alone and in combination with pembrolizumab or ipilimumab and nivolumab.

Study identification

NCT ID: NCT05533697
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: ModernaTX, Inc.; Industry
Enrollment: 361 participants

Conditions and interventions

Conditions

Advanced Solid Tumors

Interventions

mRNA-4359 Biological
Pembrolizumab Biological
Ipilimumab Biological
Nivolumab Biological

Biological

Eligibility (public fields only)

Age range: 12 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 31, 2022
Primary completion: Feb 17, 2032
Completion: Feb 17, 2032
Last update posted: Jul 13, 2026

2022 – 2032

United States locations

U.S. sites: 16
U.S. states: 13
U.S. cities: 14

Facility	City	State	ZIP	Site status
The Angeles Clinic and Research Institute	Los Angeles	California	90025	Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California	94143	Recruiting
University of Colorado Cancer Center	Aurora	Colorado	80045	Recruiting
George Washington University	Washington D.C.	District of Columbia	20037	Recruiting
Orlando Health UF Health Cancer Center	Orlando	Florida	32806	Recruiting
The University of Chicago Medicine	Chicago	Illinois	60637	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	02114	Recruiting
Dana Farber Cancer Institute	Boston	Massachusetts	02215	Recruiting
Henry Ford Hospital	Detroit	Michigan	48202	Recruiting
Washington University	St Louis	Missouri	63110	Recruiting
John Theurer Cancer Center	Hackensack	New Jersey	07601	Recruiting
NYU Langone Health-Perlmutter Cancer Center	New York	New York	10016	Recruiting
Memorial Sloan Kettering Cancer Center - Melanoma & Immunotherapeutics	New York	New York	10065	Recruiting
Carolina BioOncology Institute	Huntersville	North Carolina	28078	Completed
Oregon Health & Science University	Portland	Oregon	97239	Completed
Sara Cannon Research Institute Tennessee	Nashville	Tennessee	37203	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05533697, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 13, 2026 · Synced Sep 2, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05533697 live on ClinicalTrials.gov.

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