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Study of Pembrolizumab and Lenvatinib for Patients with Classic Kaposi Sarcoma After Previous Treatment

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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 a treatment for classic Kaposi sarcoma, a type of cancer that affects the skin, mouth, and sometimes internal organs. The study involves patients who have already received at least one previous treatment for their condition. The treatment being tested combines two medications: pembrolizumab and lenvatinib. Pembrolizumab is given as an infusion, which means it is administered directly into the bloodstream through a vein, while lenvatinib is taken orally in the form of capsules.

The purpose of the study is to evaluate how well this combination of medications works in treating patients with classic Kaposi sarcoma that has returned or not responded to standard treatments. Participants in the study will receive both pembrolizumab and lenvatinib over a period of up to 24 months. During this time, doctors will monitor the patients' response to the treatment, including any changes in their health and quality of life. The study will also look at how long the treatment effects last and how safe and tolerable the medications are for the patients.

Throughout the study, various tests and assessments will be conducted to gather information about the patients' health and the effectiveness of the treatment. This includes checking for changes in specific markers in the blood and examining tissue samples from the cancer. The study aims to provide valuable insights into the potential benefits of using pembrolizumab and lenvatinib together for treating classic Kaposi sarcoma.

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 a review of medical history and a physical examination.

    A Positron Emission Tomography-Computed Tomography (PET-CT) scan and/or dermatological examination is performed to measure the disease.

    A biopsy of at least one superficial lesion is required to provide tissue samples.

  2. Step 2

    Treatment initiation

    The treatment involves two medications: lenvatinib and pembrolizumab.

    Lenvatinib is taken orally in the form of capsules. The specific dosage and frequency will be determined by the healthcare provider.

    Pembrolizumab is administered through an intravenous infusion. The healthcare provider will specify the dosage and frequency.

  3. Step 3

    Ongoing treatment and monitoring

    Regular monitoring is conducted to assess the response to treatment. This includes physical examinations and imaging tests.

    Blood tests are performed to evaluate changes in plasma levels of certain markers and to monitor overall health.

    The healthcare team will assess the safety and tolerability of the treatment.

  4. Step 4

    Response evaluation

    The primary goal is to estimate the overall response rate to the treatment.

    Secondary evaluations include the duration of response, progression-free survival, and overall survival.

    Quality of life and physical functioning are also assessed throughout the study.

  5. Step 5

    Treatment completion

    The study continues until the estimated end date or until treatment is discontinued due to disease progression, complete response, or unacceptable side effects.

    Final assessments are conducted to evaluate the overall outcomes and any changes in health status.

Who can join the trial?

8 criteria

  • Must have a histologic diagnosis of classic Kaposi sarcoma. This means the disease has been confirmed by examining tissue under a microscope.
  • The disease must have shown progression, relapse, or inadequate response to at least one previous treatment with systemic chemotherapy. This means the disease has either gotten worse, come back, or not responded well to past treatments.
  • Must have a measurable disease that can be seen on a PET-CT scan or through a skin examination. This means the disease can be measured or seen using specific medical tests.
  • Must have at least one superficial lesion and be willing to provide a tissue sample from a skin or mucosal biopsy at the start of the study. A superficial lesion is a visible or surface-level area affected by the disease.
  • Must be 18 years or older at the time of signing the consent form to participate in the study.
  • Must have an ECOG performance status of 0 or 1 within 7 days before the first dose of the study treatment. This is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but nearly fully active.
  • Must have adequate bone marrow, liver, and kidney function. This means these organs are working well enough to participate in the study.
  • Must have adequately controlled blood pressure. This means blood pressure is within a safe range, possibly with or without medication.

Who cannot join the trial?

5 criteria

  • Patients who have not been diagnosed with advanced unresectable classic Kaposi sarcoma that has come back or did not respond to previous standard treatments cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Patients who are not female or male cannot participate.
  • Patients who are not considered part of a vulnerable population cannot participate.
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Investigated drugs

  • Pembrolizumab

    is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, pembrolizumab is being used to see if it can help treat Kaposi sarcoma, a type of cancer that affects the skin and other organs.

  • Lenvatinib

    is a medication that targets certain proteins in cancer cells, which can help slow down or stop the growth of the cancer. It is used in this trial to see if it can work together with pembrolizumab to treat Kaposi sarcoma more effectively than other treatments that patients may have tried before.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into a vein through a drip. It is currently a well-established medication in the field of oncology, with numerous studies supporting its use. The main therapeutic indication for pembrolizumab in this trial is for patients with advanced Kaposi sarcoma that has not responded to previous treatments. At the molecular level, pembrolizumab works by blocking a specific protein on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.

  • Lenvatinib

    Lenvatinib is taken orally in the form of a capsule, which means it is swallowed and absorbed through the digestive system. It is a recognized medication in cancer treatment, with a growing body of research supporting its effectiveness. In this trial, lenvatinib is used for patients with advanced Kaposi sarcoma that has not improved with standard treatments. Lenvatinib works by blocking certain proteins that promote the growth of blood vessels in tumors, effectively starving the cancer cells. It is classified as a tyrosine kinase inhibitor, a type of drug that interferes with specific enzymes involved in cancer cell growth.

Investigated diseases

Kaposi Sarcoma – Kaposi Sarcoma is a type of cancer that forms in the lining of blood and lymph vessels. It usually appears as tumors on the skin or on mucosal surfaces such as inside the mouth, but it can also affect internal organs. The disease is caused by infection with human herpesvirus 8 (HHV-8). It progresses by forming lesions that can be purple, red, or brown, and may be flat or raised. Over time, these lesions can grow and merge, potentially causing swelling and discomfort. The disease can remain localized or spread to other parts of the body, including the lungs, liver, and digestive tract.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512834-14-00Protocol codeMK-3475-B60Estimated enrolment25 patientsSponsorFondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).