Clinical Trials for Kaposi’s Sarcoma
There are currently 2 clinical trials investigating new treatments for Kaposi’s sarcoma, a type of cancer affecting the skin and other organs. These trials are exploring immunotherapy approaches to help patients whose disease has progressed or not responded well to previous treatments.
Clinical trial locations
- France
- Italy
Study of Pembrolizumab and Lenvatinib for Patients with Classic Kaposi Sarcoma After Previous Treatment
This trial is taking place in Italy and focuses on patients with classic Kaposi sarcoma who have already tried at least one previous treatment. The study tests a combination of two medications working together to fight the disease.
Main inclusion criteria: To participate, patients must have a confirmed diagnosis of classic Kaposi sarcoma that has gotten worse, come back, or not responded well to at least one previous chemotherapy treatment. The disease must be measurable using a PET-CT scan or skin examination. Participants need to be at least 18 years old and have at least one visible lesion from which a tissue sample can be taken. They should be able to perform daily activities with little to no restrictions, and their bone marrow, liver, and kidneys must be functioning adequately. Blood pressure should also be well controlled.
Main exclusion criteria: Patients who have not been diagnosed with advanced classic Kaposi sarcoma that has returned or not responded to standard treatments cannot join. Those outside the specified age range or who do not meet the clinical trial group requirements are also excluded.
Focus and goal: The trial aims to evaluate how well the combination of pembrolizumab and lenvatinib works in treating classic Kaposi sarcoma. Researchers will monitor patients for up to 24 months, tracking how the disease responds to treatment, how long the effects last, and how safe and tolerable the medications are. The study also examines quality of life and looks at specific blood markers and tissue samples to understand the treatment’s effectiveness better.
Investigational drugs: Pembrolizumab is an immunotherapy medication given through an infusion into a vein. It helps the immune system recognize and attack cancer cells by blocking a specific protein on immune cells. Lenvatinib is taken orally as a capsule and works by blocking proteins that help tumors grow blood vessels, effectively cutting off their supply. Together, these medications may provide a more effective treatment approach than either one alone.
Study of Pembrolizumab for Patients with Classic or Endemic Kaposi’s Sarcoma
This trial is being conducted in France and studies the effectiveness of pembrolizumab as a single treatment for patients with either classic or endemic forms of the disease.
Main inclusion criteria: Participants must have a tissue-confirmed diagnosis of classic or endemic Kaposi’s sarcoma that is getting worse. The disease should involve more than 10 lesions, affect more than one limb segment, or cover more than 3% of the body surface. At least 4 lesions must be 5mm or larger, and patients must have at least one additional skin tumor available for testing. They must be willing to provide tissue samples from a biopsy. Any previous treatments specific to the disease must have stopped at least 4 weeks before joining the trial. Participants must be at least 18 years old, and females who can have children must have negative pregnancy tests.
Main exclusion criteria: Patients without a confirmed diagnosis of Kaposi’s sarcoma cannot participate. Those outside the specified age range, which includes young adults and older adults, are also excluded. People considered part of vulnerable populations, such as children, pregnant women, or those unable to give consent, are not eligible.
Focus and goal: The primary goal is to determine whether pembrolizumab can effectively reduce or eliminate the cancer in patients with classic or endemic Kaposi’s sarcoma. Researchers will measure the best overall response rate, which tracks how many patients experience either a complete or partial reduction in their disease. The study monitors participants regularly for up to 24 months, closely tracking how the cancer responds to treatment and documenting any side effects.
Investigational drug: Pembrolizumab is an immunotherapy medication administered directly into a vein through an infusion. It works by blocking a protein on immune cells that normally prevents them from attacking cancer cells. By blocking this protein, pembrolizumab helps the immune system recognize and fight the cancer more effectively. This type of medication is known as an immune checkpoint inhibitor.
Summary
Both clinical trials for Kaposi’s sarcoma focus on using immunotherapy to help patients whose disease has progressed or not responded to previous treatments. The common thread between these studies is the use of pembrolizumab, a medication that helps the immune system fight cancer cells by removing the brakes that normally prevent immune cells from attacking tumors.
The Italian trial explores a combination approach, pairing pembrolizumab with lenvatinib, which targets tumor blood vessel growth. This dual approach may offer benefits for patients who have already tried other treatments. The French trial, on the other hand, focuses on pembrolizumab as a single treatment for both classic and endemic forms of the disease.
Both studies are geographically limited, with one trial each in Italy and France, suggesting these are specialized research efforts at specific centers. Patients interested in participating should discuss their eligibility with their healthcare providers, particularly regarding previous treatments, disease characteristics, and overall health status.
