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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Karolinska University Hospital	Solna	Sweden
Hfzyiu Huuolxgj	Herlev	Denmark
Azfyou Uxqkefpazr Heznjpti	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	05.12.2022
Norway	Recruiting	05.12.2022
Sweden	Not yet recruiting	05.12.2022

Trial locations

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.

Investigated diseases:

Angiosarcoma

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 ID:

2024-513727-16-00

Protocol code:

SA2115

NCT ID:

NCT05961761

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?