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Evaluation of mRNA-4359 Monotherapy and Combined Pembrolizumab Therapy in Advanced Solid Tumors: A Phase 1/2 Clinical Trial

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment called mRNA-4359 in people with advanced solid tumors. These are types of cancer that have spread beyond their original location and are more challenging to treat. The study will explore how mRNA-4359 works when given alone and when combined with another medication called pembrolizumab, which is already used to help the immune system fight cancer.

The purpose of the study is to assess the safety and tolerability of mRNA-4359 when used alone and in combination with pembrolizumab. Participants will receive the treatment through injections, and the study will monitor how their bodies respond over time. Some participants will receive a placebo, which is a substance with no active medication, to compare the effects. The study will also involve regular check-ups and tests to ensure the safety of the participants and to gather information on how the treatment affects the cancer.

The study will take place over several years, with participants being closely monitored by healthcare professionals. The goal is to better understand how mRNA-4359 can be used to treat advanced cancers and to determine the best way to use it in combination with existing treatments like pembrolizumab. This research could lead to new options for people with advanced solid tumors, providing hope for more effective treatments in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessments

    After joining the study, you will undergo a series of baseline assessments that include physical examination, vital sign measurement, laboratory tests, and imaging studies to document the status of the advanced solid tumor.

    The results of these assessments establish reference values for later comparison during the trial.

  2. Step 2

    First mrna-4359 injection

    The first dose of mrna-4359 is given as an intramuscular injection.

    The protocol does not specify a numerical dose, frequency, or duration; these details are determined by the study investigators.

  3. Step 3

    Subsequent mrna-4359 injections

    Additional doses of mrna-4359 are administered by intramuscular injection according to the schedule defined in the study protocol.

    Each injection follows the same procedure as the first dose, and safety monitoring is performed before and after each administration.

  4. Step 4

    Combination therapy with pembrolizumab (if assigned to an arm that includes it)

    If you are placed in an arm that combines mrna-4359 with pembrolizumab, you will receive pembrolizumab by intravenous infusion.

    The exact dose, frequency, and duration of pembrolizumab are not detailed in the provided information.

  5. Step 5

    Combination therapy with ipilimumab and nivolumab (if assigned to an arm that includes them)

    If you are placed in an arm that combines mrna-4359 with ipilimumab and nivolumab, you will receive each drug by intravenous infusion.

    The protocol does not list the specific doses, how often the infusions occur, or the total length of treatment for these agents.

  6. Step 6

    Regular safety monitoring visits

    Throughout the trial you will attend scheduled visits for safety monitoring, which include repeat physical examinations, vital sign checks, laboratory tests, and imaging as required.

    Any adverse events, side effects, or changes in health status are recorded and evaluated by the study team.

  7. Step 7

    Continuation or discontinuation decision

    Treatment continues until the predefined end of the study period, disease progression, or occurrence of unacceptable toxicity as determined by the investigators.

    The decision to stop treatment is based on safety assessments and clinical judgment, without requiring any additional action from you beyond attending the scheduled visits.

Who can join the trial?

11 criteria

  • Be an adult (usually 18 years or older) who can be male or female and can give consent to join the study.
  • Have a locally advanced or metastatic solid tumor (cancer that has spread) such as melanoma, non‑small cell lung cancer (NSCLC), bladder cancer, head‑and‑neck cancer, colorectal cancer, basal cell carcinoma, or triple‑negative breast cancer.
  • The cancer must be measurable (able to be sized on scans) and have a lesion that can be accessed for a biopsy (a small tissue sample).
  • The cancer must have gotten worse after standard treatments or the patient must not be able to receive those standard treatments.
  • For some study groups, the tumor must show PD‑L1 positivity (a protein on cancer cells) at a level of at least 1% as measured by a lab test.
  • If you have NSCLC with known genetic changes such as EGFR or ALK, you must have already tried (or chosen not to try) medicines that target those changes.
  • In the expansion arm for NSCLC, you must be treatment‑naïve (no prior therapy for this cancer), have PD‑L1 expression of 50% or higher, and not have EGFR or ALK alterations.
  • In the melanoma expansion cohort, you must have a centrally confirmed PD‑L1 expression of at least 1% from a screening biopsy.
  • All participants must have disease that meets the criteria of RECIST v1.1 (a standard way doctors measure tumor size) and must provide a baseline tumor biopsy before treatment.
  • You must have an ECOG performance status of 0 or 1, meaning you are fully active (0) or able to carry out light work (1) but not bedridden.
  • Your blood tests must show adequate hematological and biological function (healthy blood counts, liver and kidney function) to safely receive the study treatment.

Who cannot join the trial?

17 criteria

  • Having an active central nervous system tumor (a cancer in the brain or spinal cord) or cancer that has spread (called metastases) to that area.
  • For certain melanoma groups only: a tumor sample taken within the last 90 days must be usable for testing, must show at least 1% of a protein called PD‑L1 (measured by a special lab test), and you cannot have received any other cancer treatment between the sample date and the start of the study.
  • Having nerve damage (called neuropathy) that is rated higher than moderate severity (greater than Grade 2).
  • Receiving radiotherapy (radiation treatment) within 14 days before the first study dose, unless it was palliative radiation and you had a 7‑day break (washout) before starting.
  • Having a history of severe allergic reactions to any of the medicines used in the study.
  • Having serious heart problems, as defined in the study protocol.
  • Having another invasive cancer diagnosed within the past 3 years, unless it was treated with the goal of cure and there is no evidence of disease left.
  • Having experienced severe or unresolved side effects from previous immunotherapy drugs such as anti‑PD‑1, anti‑PD‑L1, or anti‑CTLA‑4 (these are special cancer‑fighting medicines), including permanent stopping of treatment because of toxicity or nerve/eye problems.
  • Having an active infection such as tuberculosis, hepatitis B, hepatitis C, or HIV.
  • Taking any prohibited medicines or investigational drugs within the time it takes for those drugs to clear from your body (5 half‑lives) or within 14 days before the first study dose, whichever is shorter.
  • Needing additional immune‑suppressing medicines beyond standard steroids, or currently taking more than 10 mg of prednisone (or an equivalent) each day.
  • Planning to receive a live attenuated vaccine (a vaccine that contains weakened live germs) during the study, or having received such a vaccine within 30 days before the first dose.
  • Having side effects from previous cancer treatment that have not improved to the mildest level (Grade 1) or returned to your normal baseline.
  • Being unable or unwilling to use highly effective birth control methods and, for women, to avoid donating eggs, or for men, to avoid sperm donation, during treatment and for a defined period after the last dose.
  • Having unstable or serious medical conditions (such as severe infections, bleeding problems, serious gastrointestinal disease, or significant psychiatric illness) that could affect your safety or ability to follow the study rules.
  • Being enrolled in another interventional clinical study at the same time.
  • Having a diagnosis of ocular (eye) or uveal melanoma (a type of eye cancer).
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Investigated drugs

  • mRNA-4359

    is an experimental treatment that uses a piece of messenger RNA to teach the body’s immune system to recognize and attack cancer cells. It is given as a small injection into the muscle. In this study the vaccine is tested by itself and also together with other immune‑boosting medicines.

  • Pembrolizumab

    is a type of immunotherapy called a checkpoint inhibitor. It works by blocking a protein called PD‑1 on immune cells, which helps the body’s own defenses see and destroy cancer. In the trial it is given by an IV infusion and is combined with the mRNA‑4359 vaccine to see if the two work better together.

  • Nivolumab

    is another checkpoint inhibitor that also blocks the PD‑1 protein, allowing immune cells to attack tumors more effectively. It is administered through an IV infusion and is used in combination with the mRNA‑4359 vaccine and sometimes with another drug, ipilimumab, to test safety and how well the cancer responds.

  • Ipilimumab

    is a checkpoint inhibitor that targets a different protein called CTLA‑4 on immune cells. By blocking CTLA‑4, it helps the immune system become more active against cancer. It is given by IV infusion and is tested together with mRNA‑4359 and nivolumab to see if the combination is safe and can shrink tumors.

What is already known about the treatment

  • Pembrolizumab

    This medication is given by intravenous infusion. It is an approved cancer drug that is widely studied in medical literature and used for many solid tumors such as melanoma and lung cancer. Pembrolizumab works by attaching to the PD‑1 protein on immune cells, stopping the tumor from turning off the immune response. It belongs to the class of monoclonal antibody immune checkpoint inhibitors.

  • Nivolumab

    Nivolumab is administered as an intravenous solution for infusion. It is an approved therapy for several cancers, including kidney, lung, and head‑and‑neck tumors, and is well documented in clinical research. The drug blocks the PD‑1 receptor on T‑cells, allowing the immune system to recognize and attack cancer cells. It is classified as a monoclonal antibody PD‑1 inhibitor.

  • Ipilimumab

    Ipilimumab is delivered by intravenous infusion of a solution. It is an approved treatment mainly for melanoma and is recognized in many clinical studies. Ipilimumab binds to the CTLA‑4 protein on T‑cells, removing a brake on the immune system and boosting its ability to fight cancer. It falls under the category of monoclonal antibody immune checkpoint blockers.

  • Sodium chloride

    Sodium chloride is given as an intramuscular injection of a sterile salt solution. It is a standard, approved electrolyte product used to replace lost fluids and salts in many medical settings. The solution provides sodium and chloride ions that help maintain normal fluid balance in the body. It is classified as an electrolyte solution and is not a cancer‑specific drug.

Investigated diseases

Advanced solid tumor - A solid tumor is a mass of abnormal cells that forms in organs or tissues such as the lung, breast, colon, or bone. When the tumor grows larger and spreads beyond its original location, it is considered advanced. The cancer cells continue to divide, infiltrate surrounding tissue, and can travel through blood or lymph to create new tumors in other parts of the body. As the disease progresses, the number and size of tumors typically increase, leading to greater impact on organ function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-504506-11-00Protocol codemRNA-4359-P101Estimated enrolment196 patientsSponsorModerna Therapeutics Inc.

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