Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase1/Phase2

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

Sponsor: ModernaTX, Inc.

NCT ID: NCT05533697

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
mRNA-4359 (biological), Pembrolizumab (biological), Ipilimumab (biological), Nivolumab (biological)
How long the study runs
Study runs about 113 months (dates as stated)
About the drug or intervention
mRNA-4359 — biological: Intramuscular Injection · Pembrolizumab — biological: Intravenous infusion · Ipilimumab — biological: Intravenous infusion · Nivolumab — biological: Intravenous infusion
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a new cancer treatment called mRNA-4359, given on its own or together with existing immunotherapy drugs (drugs that help the immune system fight cancer). It is for adults with advanced solid tumours, which are cancers such as melanoma (a skin cancer) and lung cancer. The study is run by ModernaTX, Inc.

Who can take part

  • Adults aged 18 or over (children aged 12 or over can join one part of the study, called Arm 2d)
  • Have an advanced or metastatic cancer (cancer that has spread), such as melanoma, lung cancer, bladder cancer, head and neck cancer, bowel cancer, basal cell skin cancer, or triple negative breast cancer, depending on the study part
  • Have cancer that can be measured on scans and that has either not responded to standard treatment, or has not yet been treated, depending on the study part
  • Have a tumour that can be biopsied (a small sample taken), with another tumour that can be watched on scans
  • Be well enough in daily life (performance status score of 1 or less on a scale used by doctors)
  • Have blood and body organs working well enough
  • Give written permission (consent) to take part

Who may not be able to

  • Cancer that has spread to the brain or spinal cord, or active brain tumours
  • Recent or planned cancer treatment such as chemotherapy, radiotherapy, hormone therapy or other immunotherapy, or other experimental drugs close to starting the study
  • Still having side effects from earlier cancer treatment, unless mild
  • Pregnant or breastfeeding, or not willing to use very reliable contraception during and after treatment
  • Recent or planned live vaccines (vaccines containing a weakened living germ), such as measles or yellow fever vaccines. Flu jabs and non-live COVID-19 vaccines are usually allowed
  • Needing more than 10 mg of steroid medicine (prednisone or similar) per day
  • Serious other health problems, such as ongoing infections or lung disease, that could make taking part unsafe or too difficult
  • Taking part in another clinical trial at the same time

What taking part involves

  • • Receiving the study drug mRNA-4359, either alone or combined with immunotherapy drugs called immune checkpoint inhibitors
  • • Having tumour biopsies (small samples of the tumour taken), at the start and sometimes later during treatment
  • • Regular scans to check whether the cancer is changing

Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and exactly what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
12 Years and over
Who
All
Number of participants
361
Started
2022-09-01
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for advanced solid tumors
  • • Phase1/Phase2 - 361 participants
  • • 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

Who can take part?

  • • Ages 12 Years and over
  • • Diagnosed with advanced solid tumors

Where?

  • • Preston - Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
  • • Glasgow - Beatson West of Scotland Cancer Centre
  • • Birmingham - Queen Elizabeth Hospital Birmingham
  • • London - University College London Hospitals NHS Foundation Trust
  • • +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Advanced Solid Tumors

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 12 Years and over
  • Who can join: All genders

Biomarkers mentioned

triple negativePD-L1EGFRALKROS1ALK positive

Treatment history

Treatments you must have had:

  • ✓ primary refractory or acquired secondary resistance to prior immune checkpoint treatments
  • ✓ prospective central testing of Screening tumor biopsies to confirm PD-L1 TPS ≥1% for eligibility
  • ✓ measurable disease as determined by RECIST v1
  • ✓ another lesion outside of the lesion biopsied at baseline that can be followed as a RECIST v1

What the study is looking for

  • ✓Dose Expansion Arms (Arm 2): Participant has confirmed by a biopsy:
  • ✓Arm 2a: that has grown locally or that has spread melanoma who have not yet received any prior treatment that goes through your whole body for their...
  • ✓Arm 2c: that has grown locally or that has spread melanoma in participants who have not received prior treatment that goes through your whole body for...
  • ✓Arm 2d: Advanced/that has spread melanoma that is CPI refractory and having a centrally confirmed PD-L1 TPS of ≥1% on...
  • ✓All participants must have cancer that can be measured on scans as determined by (standard scan measurements).

Who cannot take part

  • ✗Participant has active central nervous system tumors or metastases.
  • ✗Participant has concurrent enrollment in another clinical study (unless it is an observational noninterventional...
See the full criteria
Key Inclusion Criteria: * Males or females ≥18 years of age who have provided written informed consent prior to completing any study-specific procedure. For Arm 2d, participants ≥12 years are eligible with informed consent/assent. * Dose Escalation (Arm 1a): Participant has histologically confirmed locally advanced or metastatic cancer (cutaneous melanoma, NSCLC, non-muscle invasive bladder cancer, head and neck squamous cell carcinoma, microsatellite stable colorectal cancer \[MSS CRC\], basal cell carcinoma, or triple negative breast cancer) with measurable disease as determined by RECIST v1.1. Arm 1a participants must have received, and then progressed, relapsed, or been intolerant to, or ineligible for, at least 1 standard treatment regimen in the advanced or metastatic setting. Participants with a known driver mutation must have also received or been offered a mutation-directed therapy, where indicated. Participants must have a tumor lesion amenable to biopsy and must have another lesion that can be followed for response. * Dose Confirmation (Arm 1b): Participant has histologically confirmed locally advanced or metastatic, and CPI refractory melanoma or locally advanced or metastatic, and CPI refractory NSCLC with measurable disease as determined by RECIST v1.1 who has disease progression after, at least 1 line of standard therapy (no limit to prior lines of therapy), and has been treated with or refused standard of care treatment. Participants in PD arm Group 2 must also have PD-L1 TPS ≥1%. Participants must have primary refractory or acquired secondary resistance to prior immune checkpoint treatments. Primary refractory is defined as prior exposure to anti-programmed death-1 (PD-1)/PD-L1 antibody for at least 6 weeks but no more than 6 months with demonstration of progression on 2 separate scans at least 4 weeks apart but no more than 12 weeks apart and progression occurring within 6 months after first dose of anti-PD-1 antibody. Acquired secondary resistance must have confirmed objective response or prolonged stable disease (SD) (\>6 months), followed by disease progression in the setting of ongoing treatment and confirmed progression on scans at least 4 weeks apart. Participants must have a tumor lesion amenable to biopsy and must have another lesion that can be followed for response. 1. For NSCLC participants with known EGFR, ALK, proto-oncogene tyrosine-protein kinase reactive oxygen species (ROS1), or other actionable mutations for which there are approved targeted therapies, participants must have received prior approved targeted therapy or have been offered and declined approved targeted therapy. 2. Expansion of the melanoma Arm 1b cohort (up to approximately 16 additional evaluable participants) will require prospective central testing of Screening tumor biopsies to confirm PD-L1 TPS ≥1% for eligibility. * Dose Expansion Arms (Arm 2): Participant has histologically confirmed: 1. Arm 2a: Locally advanced or metastatic melanoma who have not yet received any prior systemic therapy for their melanoma in this setting. 2. Arm 2b: Newly diagnosed locally advanced or metastatic NSCLC with a PD-L1 TPS of ≥50% with no known EGFR or ALK positive tumor mutations who have not yet received any prior systemic therapy for their NSCLC (that is, treatment-naive). 3. Arm 2c: Locally advanced or metastatic melanoma in participants who have not received prior systemic therapy for melanoma in the advanced/metastatic setting. 4. Arm 2d: Advanced/metastatic melanoma that is CPI refractory and having a centrally confirmed PD-L1 TPS of ≥1% on their Screening tumor biopsy. * All participants must have measurable disease as determined by RECIST v1.1. * Participants must have a tumor lesion amenable to biopsy and must provide tumor biopsy sample at baseline (archival formalin-fixed, paraffin-embedded \[FFPE\] tissue collected within 90 days of informed consent is accepted as long as no intervening therapy is received, during this time), and optionally at all on-treatment timepoints (including response or progression) if medically feasible. Participants in Arm 2c: Sufficient tumor tissue (slides or FFPE block) for PD-L1 testing is required as per Laboratory Manual. Participants in Arm 2c may be replaced in this cohort if not PD-L1 evaluable. Participants in Arm 1b melanoma expansion cohort and Arm 2d: Central confirmation of PD-L1 TPS score is required prior to enrollment. * If the participant is undergoing a new biopsy, they must have another lesion outside of the lesion biopsied at baseline that can be followed as a RECIST v1.1 target lesion for response. * Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1. * Participant has adequate hematological and biological function. Key Exclusion Criteria: * Participant has active central nervous system tumors or metastases. * Participant has received treatment with prohibited medications (that is, concurrent anticancer therapy including other chemotherapy, radiation \[local radiation for palliative care is permitted with approval from the Sponsor\], hormonal anticancer treatment, biologic therapy, or immunotherapy) or investigational agents within 5 half-lives or 14 days prior to the first day of study treatment, whichever is shorter. Prior exposure to any investigational or approved agent designed to simultaneously target both indoleamine 2,3-dioxygenase (IDO1) and PD-L1 is also exclusionary. * Participant has required the use of additional immunosuppression (for example, infliximab) other than corticosteroids for the management of an AE, has experienced recurrence of an AE if rechallenged, and currently requires maintenance doses of \>10 milligrams (mg) prednisone or equivalent per day. * Participant has any plan to receive a live attenuated vaccine during study treatment or has received a live vaccine within 30 days before the first dose of study treatment. Examples of live vaccines include, but are not limited to measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines and non-live coronavirus disease 2019 (COVID-19) for injection are generally allowed. * Participant has reversible toxicities from prior cancer therapy that have not recovered to Grade 1 or baseline. Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and prespecified laboratory values. * Participant who is pregnant, breastfeeding, or is of childbearing potential, defined as those who are capable of becoming pregnant who are not willing to employ a highly effective method of contraception during dosing and for 90 days after the last dose of mRNA-4359 or 4 months after the last dose of pembrolizumab or 5 months after the last dose of ipilimumab/nivolumab administrations, whichever is longer. * Sexually active participants who refuse to use a condom during intercourse or participants who will not refrain from sperm donation while taking study treatment and for 90 days after the last dose of mRNA-4359 or 4 months after the last dose of pembrolizumab or 5 months after the last dose ipilimumab/nivolumab, whichever is longer, or who will not refrain from sperm donation for the same time period. * Participant has any unstable or clinically significant concurrent medical condition (for example, substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, and symptomatic pulmonary embolism) that would, in the opinion of the Investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol. Also including but not limited to, ongoing or active infection, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, active gastrointestinal bleeding or hemoptysis or history of bleeding disorder, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the participant to give written informed consent. * Participant has concurrent enrollment in another clinical study (unless it is an observational noninterventional clinical study).

Where Is This Study? (9 UK sites)

Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital

Preston PR2 9HT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Paul Brown

Research.Access@lthtr.nhs.uk01772 522031

Beatson West of Scotland Cancer Centre

Glasgow G12 0YN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jennifer McLean

jennifer.mclean@health.scot.nhs.uk0131 537 4718

Queen Elizabeth Hospital Birmingham

Birmingham B15 2GW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

University College London Hospitals NHS Foundation Trust

London NW1 2PG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Guy's and St. Thomas' NHS Foundation Trust

London SE1 7EH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Imperial College London

London W12 0HS, United Kingdom

Recruiting
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

The Christie NHS Foundation Trust - Cancer Research Centre

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Churchill Hospital

Oxford OX3 7LE, United Kingdom

Recruiting

University Hospital Southampton NHS Foundation Trust

Southampton SO16 6YD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

How to Get in Touch

Moderna WeCare Team

Sponsor contact

CONTACT

1-866-663-3762 WeCareClinicalTrials@modernatx.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07