Study of Pembrolizumab for Patients with Classic or Endemic Kaposi’s Sarcoma

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What is this study about?

This clinical trial is focused on studying a disease called Kaposi’s sarcoma, which is a type of cancer that forms in the skin, lymph nodes, or other organs. The study is investigating the effects of a treatment called pembrolizumab, which is a medication given through an infusion into the vein. Pembrolizumab is a type of protein that helps the immune system fight cancer cells.

The purpose of the study is to determine if pembrolizumab is effective in treating classic or endemic Kaposi’s sarcoma. Participants in the study will receive pembrolizumab and will be monitored to see how their disease responds to the treatment. The study will look at how many patients experience a reduction in their cancer, either partially or completely, over a period of time. This will help researchers understand if pembrolizumab can be a useful treatment for this type of cancer.

Throughout the study, participants will receive regular infusions of pembrolizumab and will have their health closely monitored by the research team. The study will last for several months, and participants will be checked regularly to see how their cancer is responding to the treatment. The information gathered from this study will contribute to understanding the potential benefits of pembrolizumab for patients with Kaposi’s sarcoma.

1 initial visit

Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria, such as having **Kaposi’s sarcoma** with certain characteristics.

A physical examination is conducted, and medical history is reviewed. A biopsy of a tumor lesion may be required for further evaluation.

2 treatment initiation

The treatment involves the administration of **pembrolizumab**. This medication is given through an intravenous infusion, which means it is delivered directly into a vein.

The dosage and frequency of **pembrolizumab** administration are determined by the study protocol. The treatment continues for a specified duration, which may extend up to 24 months, depending on the response and other factors.

3 regular follow-up visits

Regular follow-up visits are scheduled to monitor the response to the treatment. These visits include physical examinations and possibly additional biopsies to assess the effect of the medication.

During these visits, any side effects or changes in health are documented and addressed.

4 response assessment

The primary goal is to evaluate the **Best Overall Response Rate (BORR)**, which measures the occurrence of complete or partial response to the treatment.

This assessment is conducted from the start of the treatment until 6 months, or until any other specific therapy for **Kaposi’s sarcoma** begins, if it occurs before 6 months.

5 extension stage

If applicable, the extension stage of the study may continue to assess the response rate up to 24 months.

The same criteria for response assessment apply during this stage, ensuring a comprehensive evaluation of the treatment’s effectiveness.

Who Can Join the Study?

Have a diagnosis of classic or endemic Kaposi’s sarcoma (KS), confirmed by a tissue sample.
Have a progressive disease, meaning the condition is getting worse.
Have KS with more than 10 lesions, or affecting more than one limb segment, or covering more than 3% of the body surface.
Have at least 4 KS lesions that are 5mm or larger.
Have at least one other skin tumor available for repeated testing and be willing to provide a tissue sample from a skin biopsy of a tumor lesion.
Have stopped all KS-specific treatments, including chemotherapy and immunotherapy like Interferon, for at least 4 weeks.
Be at least 18 years old on the day of signing the consent form.
If female and able to have children, must have a negative blood pregnancy test within 72 hours before the first dose of study medication, and a negative urine pregnancy test before each subsequent dose.

Who Cannot Join the Study?

Patients who do not have Kaposi’s sarcoma cannot participate. Kaposi’s sarcoma is a type of cancer that forms in the skin, lymph nodes, or other organs.
Patients who are not within the specified age range cannot participate. The age range includes young adults and older adults.
Both male and female patients are eligible, but if you do not identify as either, you may not be eligible.
Patients who are considered part of a vulnerable population are not eligible. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Alhehljtoe Pfwanpnm Hlpjmkjt Dz Mlzqygoey	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	26.06.2018

Trial locations

Investigated drugs:

Pembrolizumab

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. In this trial, pembrolizumab is being tested to see if it can help treat Kaposi’s sarcoma, a type of cancer that affects the skin, mouth, and other organs. The goal is to find out if pembrolizumab can reduce the size of the cancer or make it disappear completely in people with this condition.

Investigated diseases:

Kaposi's sarcoma

Kaposi’s sarcoma – Kaposi’s sarcoma is a type of cancer that forms in the lining of blood and lymph vessels. It typically appears as tumors on the skin or on mucosal surfaces such as inside the mouth, but it can also affect internal organs. The disease progresses by forming lesions that may be purple, red, or brown, and can be flat or raised. Over time, these lesions can grow in size and number, potentially causing swelling and discomfort. The progression of Kaposi’s sarcoma can vary, with some cases remaining localized while others spread to other parts of the body. The disease is associated with human herpesvirus 8 (HHV-8) infection, which plays a role in its development.

Trial ID:

2024-514241-10-00

Protocol code:

P160601j

NCT ID:

NCT03469804

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Pembrolizumab for Patients with Classic or Endemic Kaposi’s Sarcoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?