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A study of PM54 and pembrolizumab in adults with advanced cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study is being conducted to evaluate the safety and effectiveness of combining the experimental drug PM54 with pembrolizumab in adults with advanced malignancies, which refers to cancers that have spread to other parts of the body. The treatment is administered through an intravenous infusion, a method where medicine is delivered directly into a vein.

The research aims to determine the best dose of the study drugs and how well the combination works in different types of cancer. Participants will receive these medications as part of a structured process to monitor how the body reacts to the treatment. During the study, the focus is on observing how the drugs are tolerated and tracking any side effects that may occur.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>treatment initiation</b>

    The administration of pembrolizumab and pm54 begins via intravenous infusion, which means the medicine is delivered directly into a vein.

  2. Step 2

    <b>safety and dose assessment</b>

    During the initial phase, the focus is on monitoring safety and tolerability to determine the recommended dose. this involves observing any adverse events, which are side effects or unintended medical occurrences, and dose-limiting toxicities, which are severe side effects that may require a change in the amount of medicine given.

  3. Step 3

    <b>monitoring and efficacy evaluation</b>

    Throughout the study, effectiveness is measured by tracking how the malignancy, or cancer, responds to the combined treatment. this includes observing the objective response rate, which is the percentage of patients whose tumors shrink or disappear, and the disease control rate, which measures how many patients have stabilized disease.

  4. Step 4

    <b>long-term follow-up</b>

    The progress is tracked through indicators such as progression-free survival, which is the length of time spent living without the disease getting worse, and overall survival. additionally, the levels of pembrolizumab and pm54 in the plasma, which is the liquid part of the blood, are measured periodically.

Who can join the trial?

16 criteria

  • You must have read, understood, and signed the informed consent form, which is a document that explains all the details of the study before you agree to join.
  • Your cancer must have progressed, meaning it has grown or spread, despite having received previous medical treatments.
  • You must have an ECOG performance status of 0 or 1, which is a scale used by doctors to measure how well you can perform daily activities and how much the disease affects your physical function.
  • You must not have any ongoing toxicities, which are harmful side effects from previous cancer treatments, that are rated as moderate or severe, with some exceptions for mild side effects like hair loss.
  • Certain stable conditions from previous immunotherapy, such as issues with the thyroid, blood sugar, or adrenal glands, are allowed if they are managed with a steady dose of medication.
  • If you have metastases in the central nervous system (cancer that has spread to the brain or spinal cord), they must be stable, showing no new symptoms, and not requiring high doses of steroids.
  • If you have had brain radiation, at least 2 weeks must have passed before starting the study.
  • You must not have had a seizure (an uncontrolled electrical disturbance in the brain) in the 4 weeks before starting treatment.
  • Your laboratory parameters, such as blood tests, must show that your organs are functioning well enough to participate.
  • You must have fully recovered from the physical effects of any previous surgeries or radiation treatments.
  • You must be willing to follow all study procedures, including giving biological samples like blood for testing.
  • Women of childbearing potential must provide evidence that they are not pregnant and must agree to use highly effective contraception (birth control) during the study and for 7 months after the last treatment.
  • Male participants with partners who can become pregnant must agree to use condoms during the treatment and for 4 months after.
  • You must be an adult, aged 18 years or older.
  • Your cancer must be advanced, meaning it has spread or returned and cannot be completely removed by surgery or other curative treatments.
  • Your cancer must be measurable, meaning a doctor can clearly see and track the size of the tumors using standard medical imaging.

Who cannot join the trial?

22 criteria

  • You cannot participate if you have previously used PM54 or any other ecteinascidin agent, which is a specific class of cancer medication including drugs like ecubectedin, trabectedin, and lurbinectedin.
  • You are excluded if you test positive for the Hepatitis B virus (HBV) with a high level of the virus in your blood (HBV DNA ≥1000 IU/mL). If you have a low level of the virus or a suspected hidden infection, you must take preventive medicine to stop the virus from becoming active again before joining.
  • You cannot join if there is a high risk of physical damage to important body parts, such as major blood vessels, large airways, or the vertebral spine (the bones that make up your backbone).
  • Pregnant women or those who are breastfeeding are not eligible.
  • Men and women who are able to have children and are not using a highly effective method of contraception (birth control to prevent pregnancy) are excluded.
  • You are excluded if you have a history of hypersensitivity, which means an allergic reaction, to PM54, pembrolizumab, or any of the inactive ingredients used to make the medicine.
  • You cannot participate if you have had other types of malignancies (cancer) within the last 3 years, unless it was a skin cancer that was fully removed or a disease that is not likely to return.
  • You are excluded if you have carcinomatous meningitis, which is a condition where cancer spreads to the protective layers covering the brain and spinal cord.
  • You are excluded if you have certain cardiovascular (heart and blood vessel) issues, such as:
    • A history of myocardial infarction (heart attack), CNS infarction (stroke), or other issues with the arteries within the last 6 months.
    • Heart failure that is moderate or severe, or an LVEF (a measurement of how much blood your heart pumps out with each beat) of less than 45%.
    • Arrhythmia (an irregular heartbeat) or other significant ECG (an electrical test of the heart) abnormalities.
    • A QTc interval (a measurement of the time it takes for your heart muscle to recharge between beats) that is longer than the normal range.
    • You are excluded if you have respiratory (lung) issues, such as:
      • A history of ILD (interstitial lung disease, which is scarring of the lung tissue) or pneumonitis (inflammation of lung tissue) that required steroids or other medicines to lower your immune system response.
      • Severe lung disorders like COPD (chronic obstructive pulmonary disease), asthma, or restrictive lung disease, or having extra fluid around the lungs (pleural effusions).
      • A recent or worsening pulmonary embolism (a blood clot in the lung) or deep vein thrombosis (a blood clot in a deep vein, usually in the leg) within the last 2 months.
      • You are excluded if you have a history of autoimmune or connective tissue disease (conditions where the body's immune system attacks its own healthy tissues) that might get worse with the study medicine or has required high doses of corticosteroids (strong anti-inflammatory medicines) in the last year.
      • You cannot participate if you have an uncontrolled infection or an unexplained fever.
      • You are excluded if you have previously had a bone marrow or stem cell transplantation.
      • You are excluded if you have any other medical, behavioral, or social condition that the doctor believes makes it unsafe for you to take the study medicine or undergo the required procedures.
      • You cannot join if you have recently used other anticancer treatments without waiting for a sufficient washout period (a specific amount of time for the drug to leave your body) before starting the study.
      • You are excluded if you have an active HIV infection, unless you are on proper medicine, have an undetectable viral load (very little virus in the blood), and have a healthy level of CD4+ lymphocytes (a type of white blood cell that helps fight infection).
      • You are excluded if you test positive for HCV RNA, which indicates an active Hepatitis C infection.
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Investigated drugs

  • Pembrolizumab

    is a type of immunotherapy that helps the body's immune system recognize and fight cancer cells.

  • PM54

    is an experimental treatment being studied to see if it can work effectively when used together with immunotherapy.

What is already known about the treatment

  • Pembrolizumab

    This medication is an immunotherapy drug administered through an intravenous infusion into a vein. It is currently widely used in medical practice to treat various types of advanced cancers. The drug works by attaching to a specific protein on immune cells, which helps the body's own immune system recognize and attack cancer cells more effectively. It is classified as a checkpoint inhibitor.

  • PM54

    This substance is provided as a powder that is mixed into a liquid and then given through an intravenous infusion. It is currently being studied in clinical trials to see how well it works when combined with other treatments for advanced cancers. While its exact mechanism is still under investigation, it is being tested to see if it can enhance the body's response to therapy. It is classified as an investigational therapeutic agent.

Investigated diseases

Malignancy - This is a condition where abnormal cells grow uncontrollably and can spread to other parts of the body. These cells often form masses known as tumors. As the condition progresses, the cells may invade nearby tissues and interfere with normal bodily functions. The growth pattern and speed of the cells can vary depending on the specific type of cancer.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-523774-16-00Protocol codePM54-A-003-25Estimated enrolment148 patientsSponsorPharma Mar S.A.

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