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Study on Propranolol and Pembrolizumab for Patients with Advanced Angiosarcoma and Undifferentiated Pleomorphic Sarcoma

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 clinical trial is focused on studying two types of cancer: Advanced Angiosarcoma and Undifferentiated Pleomorphic Sarcoma. These are rare and aggressive forms of cancer that can occur in various parts of the body. The study will explore the effects of a combination treatment using two medications: Propranolol Hydrochloride and Pembrolizumab. Propranolol Hydrochloride is a type of medication known as a beta-blocker, which is commonly used to treat heart conditions but is being investigated here for its potential effects on cancer. Pembrolizumab, also known by its brand name Keytruda, is an immunotherapy drug that helps the immune system fight cancer cells.

The purpose of this study is to evaluate how well this combination treatment works in controlling the growth of these cancers over a period of three months. Participants in the study will receive both medications, with Propranolol Hydrochloride taken orally in the form of tablets and Pembrolizumab administered through an intravenous infusion, which means it is given directly into a vein. The study will monitor the participants' health and the progression of their cancer during this time.

Throughout the study, participants will have regular visits to the clinic for treatment and monitoring. This will include various tests and assessments to track the cancer's response to the treatment. The study aims to provide valuable information on whether this combination of medications can help improve outcomes for patients with these challenging types of cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure the patient meets the study criteria.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of two medications: propranolol hydrochloride and pembrolizumab.

    Propranolol hydrochloride is taken orally. The specific dosage and frequency are determined by the study protocol and the patient's condition.

    Pembrolizumab is administered intravenously as a solution for infusion. The dosage is 25 mg/mL, and the frequency of administration is specified by the study protocol.

  3. Step 3

    Ongoing monitoring

    Throughout the study, regular monitoring is conducted to assess the patient's response to treatment. This includes scheduled visits for physical examinations, laboratory tests, and imaging studies.

    The patient's health and any side effects experienced are closely monitored to ensure safety and effectiveness of the treatment.

  4. Step 4

    Evaluation of treatment response

    The response to treatment is evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). This involves measuring the size of the tumor and determining any changes over time.

    The primary goal is to determine the progression-free survival rate at 3 months.

  5. Step 5

    Completion of treatment

    The treatment phase continues until the study's end date or until the patient no longer benefits from the treatment.

    Upon completion, a final assessment is conducted to evaluate the overall response and any long-term effects of the treatment.

Who can join the trial?

15 criteria

  • Participants must sign a written consent form approved by the relevant authorities before any study-related procedures that are not part of regular care.
  • The level of a substance called serum bilirubin in the blood must be no more than 1.5 times the normal limit. For those with a condition called Gilbert's Syndrome, the total bilirubin must be 50 mmol/L or less.
  • Levels of liver enzymes called AST and ALT must be no more than 5 times the normal limit.
  • The level of serum creatinine in the blood must be no more than 1.5 times the normal limit, or the creatinine clearance (a measure of kidney function) must be at least 40 mL/min.
  • Women who can have children must agree to use effective birth control methods during the study and for at least 120 days after treatment. These methods include birth control pills, intrauterine devices, injections, implants, patches, or vaginal rings.
  • Men who are sexually active with women who can have children must use effective birth control methods during the study and for at least 120 days after treatment.
  • Women who cannot have children (due to menopause or surgery) and men who cannot father children do not need to use birth control.
  • Participants must be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary tests and procedures.
  • Participants must have a confirmed diagnosis of advanced or spreading Angiosarcoma or Undifferentiated Pleomorphic Sarcoma that has not responded to standard chemotherapy.
  • Participants must be at least 18 years old.
  • Participants must have an ECOG Performance Status score of 2 or less, which measures their ability to perform daily activities.
  • Participants must have a disease that can be measured according to specific criteria called RECIST version 1.1.
  • Participants must provide a sample of tumor tissue taken within 3 months before joining the study for research purposes. If not available, a new biopsy may be needed.
  • The absolute neutrophil count (a type of white blood cell) must be at least 1 x 10⁹/L.
  • The platelet count (cells that help with blood clotting) must be at least 75 x 10⁹/L.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the ones being studied, which are Advanced Angiosarcoma and Undifferentiated Pleomorphic Sarcoma.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or attend the required visits.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had a recent surgery or treatment that might affect the study results.
  • Patients who have allergies or reactions to the study medication or its ingredients.
  • Patients who have a history of substance abuse or other conditions that might affect their ability to participate.
  • Patients who are unable to provide informed consent, which means they cannot fully understand and agree to the study details.
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Investigated drugs

  • Propranolol

    is a medication commonly used to treat high blood pressure, irregular heartbeats, and other heart-related conditions. In this clinical trial, it is being studied for its potential effects on certain types of cancer, specifically advanced Angiosarcoma and Undifferentiated Pleomorphic Sarcoma. Researchers are interested in how propranolol might help slow down or stop the growth of these tumors.

  • Pembrolizumab

    is an immunotherapy drug that helps the body's immune system fight cancer. It works by blocking a specific protein on cancer cells, allowing the immune system to better recognize and attack these cells. In this trial, pembrolizumab is being tested to see if it can improve outcomes for patients with advanced Angiosarcoma and Undifferentiated Pleomorphic Sarcoma.

What is already known about the treatment

  • Propranolol

    Propranolol is typically administered orally in tablet form and is well-known as a beta-blocker. It is currently being studied in combination with other treatments for its potential benefits in managing certain types of cancer, such as advanced angiosarcoma and undifferentiated pleomorphic sarcoma. Its primary therapeutic use is in treating high blood pressure, anxiety, and certain heart conditions. At the molecular level, propranolol works by blocking beta-adrenergic receptors, which reduces heart rate and blood pressure. It is classified pharmacologically as a non-selective beta-adrenergic antagonist.

  • Pembrolizumab

    Pembrolizumab is administered through intravenous infusion and is a well-established immunotherapy drug. It is currently used in clinical trials to explore its effectiveness in treating advanced angiosarcoma and undifferentiated pleomorphic sarcoma. Pembrolizumab is primarily indicated for various types of cancer, including melanoma and non-small cell lung cancer. It works by inhibiting the PD-1 pathway, which enhances the immune system's ability to detect and destroy cancer cells. Pembrolizumab is classified as a monoclonal antibody and immune checkpoint inhibitor.

Investigated diseases

  • Advanced Angiosarcoma

    This is a rare and aggressive cancer that originates in the cells lining blood vessels or lymph vessels. It can occur in any part of the body but is most commonly found in the skin, breast, liver, and spleen. The disease is characterized by rapidly growing tumors that can spread to other parts of the body. As it progresses, patients may experience swelling, pain, and skin changes in the affected area. Angiosarcoma is known for its tendency to recur after treatment and its potential to metastasize to distant organs.

  • Undifferentiated Pleomorphic Sarcoma

    This is a type of soft tissue sarcoma that lacks a specific line of differentiation, meaning the cancer cells do not resemble any normal cell type. It typically occurs in the extremities, such as the arms or legs, but can also develop in the trunk or retroperitoneum. The disease is characterized by a rapidly enlarging mass that may be painful or tender. As it progresses, it can invade surrounding tissues and has the potential to spread to other parts of the body. This sarcoma is often diagnosed at an advanced stage due to its aggressive nature.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513727-16-00Protocol codeSA2115Estimated enrolment100 patientsSponsorRegion Hovedstaden

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