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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (9 UK sites)
Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
Preston PR2 9HT, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow G12 0YN, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham B15 2GW, United Kingdom
University College London Hospitals NHS Foundation Trust
London NW1 2PG, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Guy's and St. Thomas' NHS Foundation Trust
London SE1 7EH, United Kingdom
Imperial College London
London W12 0HS, United Kingdom
The Christie NHS Foundation Trust - Cancer Research Centre
Manchester M20 4BX, United Kingdom
Churchill Hospital
Oxford OX3 7LE, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton SO16 6YD, United Kingdom
How to Get in Touch
Moderna WeCare Team
Sponsor contactCONTACT
