Actively Recruiting
Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors
Led by ModernaTX, Inc. · Updated on 2026-04-03
361
Participants Needed
28
Research Sites
493 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older with informed consent; for Arm 2d, participants aged 12 years or older with consent/assent
- Histologically confirmed locally advanced or metastatic cancer such as melanoma, NSCLC, bladder cancer, head and neck cancer, colorectal cancer, basal cell carcinoma, or triple negative breast cancer with measurable disease
- Participants in dose escalation arm must have progressed after or be intolerant/ineligible for at least one standard treatment; mutation-directed therapy if applicable
- Participants in dose confirmation arm must have CPI refractory melanoma or NSCLC with measurable disease and disease progression after prior therapy
- Specific eligibility for arms 2a, 2b, 2c, and 2d including treatment-naive or CPI refractory melanoma or NSCLC with PD-L1 expression as required
- Measurable disease by RECIST v1.1
- Tumor lesion amenable to biopsy and willingness to provide tumor biopsy samples
- ECOG performance status of 0 or 1
- Adequate blood and biological function
You will not qualify if you...
- Active central nervous system tumors or metastases
- Recent treatment with prohibited medications or investigational agents within 5 half-lives or 14 days prior to study treatment
- Use of additional immunosuppression beyond corticosteroids or maintenance doses over 10 mg prednisone equivalent
- Planning to receive or recent receipt of live vaccines within 30 days before treatment
- Unresolved toxicities from prior cancer therapy above Grade 1 except alopecia, vitiligo, and some lab values
- Pregnant, breastfeeding, or unwilling to use effective contraception during and after treatment as specified
- Sexual activity without condom use or refusal to avoid sperm donation during and after treatment as specified
- Unstable or clinically significant medical conditions or infections that may affect safety or compliance
- Concurrent enrollment in another clinical interventional study (except observational noninterventional studies)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
Actively Recruiting
2
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143
Actively Recruiting
3
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
4
George Washington University
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
5
Orlando Health UF Health Cancer Center
Orlando, Florida, United States, 32806
Actively Recruiting
6
The University of Chicago Medicine
Chicago, Illinois, United States, 60637
Actively Recruiting
7
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
9
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
10
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
11
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
12
NYU Langone Health-Perlmutter Cancer Center
New York, New York, United States, 10016
Actively Recruiting
13
Carolina BioOncology Institute
Huntersville, North Carolina, United States, 28078
Completed
14
Oregon Health Sciences University
Portland, Oregon, United States, 97239
Actively Recruiting
15
Sara Cannon Research Institute Tennessee
Nashville, Tennessee, United States, 37203
Actively Recruiting
16
Southside Cancer Center
Miranda, New South Wales, Australia, 2228
Actively Recruiting
17
Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia, 2065
Actively Recruiting
18
Austin Hospital
Melbourne, Victoria, Australia, 3084
Actively Recruiting
19
One Clinical Research
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
20
NEXT Oncology Barcelona
Barcelona, Spain, 08023
Actively Recruiting
21
NEXT Oncology Madrid
Madrid, Spain, 28223
Actively Recruiting
22
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G12 0YN
Actively Recruiting
23
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom, B15 2GW
Actively Recruiting
24
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PG
Actively Recruiting
25
Guy's and St. Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH
Actively Recruiting
26
Imperial College London
London, United Kingdom, W12 0HS
Actively Recruiting
27
Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
28
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
M
Moderna WeCare Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
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