Ongoing Clinical Trials for Neuroendocrine Carcinoma of the Skin
There are currently 4 clinical trials investigating new treatments for neuroendocrine carcinoma of the skin, also known as Merkel cell carcinoma. These trials are taking place across several European countries including Belgium, France, and Italy, testing various combinations of immunotherapy and chemotherapy medications to improve treatment outcomes for patients with this rare and aggressive form of skin cancer.
Clinical trial locations
- Belgium
- France
- Study of BT-001 and Pembrolizumab for Patients with Advanced Solid Tumors, Including Sarcoma, Merkel Cell Carcinoma, Melanoma, Breast, and Lung Cancer
- Study on Reduced Dose Intensity of Pembrolizumab and Drug Combination for Patients with Advanced or Metastatic Cancer Responding to Standard Immunotherapy
- Italy
Study of BT-001 and Pembrolizumab for Patients with Advanced Solid Tumors, Including Sarcoma, Merkel Cell Carcinoma, Melanoma, Breast, and Lung Cancer
This trial is testing a new treatment approach for several types of advanced cancers, including Merkel cell carcinoma. The study uses BT-001, an experimental medication that is injected directly into the tumor, both alone and in combination with pembrolizumab, an immunotherapy drug given through an intravenous infusion. The trial is being conducted in France and Belgium.
Who can participate: The trial is open to adults aged 18 and older who have been diagnosed with advanced or metastatic Merkel cell carcinoma with lesions that can be easily injected. Participants must have tried standard treatments that did not work or that they could not tolerate. You need to have at least one lesion that can be injected, whether on the skin, under the skin, or in a lymph node. You must have an expected survival of at least 3 months and be able to carry out light work or be fully active. You should also have completed your COVID-19 vaccination at least 30 days before starting treatment.
Who cannot participate: The trial excludes pregnant or breastfeeding women, people with severe or uncontrolled medical conditions, those with known allergies to the study medications, patients with active infections requiring treatment, and those who have received live vaccines within 30 days before the study. You also cannot participate if you have certain heart conditions or if you are in another clinical trial at the same time.
What the trial aims to do: The main goal is to assess the safety and effectiveness of BT-001, both when used alone and in combination with pembrolizumab. The study will evaluate how well these treatments work at the tumor site and throughout the body, determine the best dose of BT-001, and measure the overall impact on the cancer. Some participants may receive a placebo to help compare the effects of the actual treatment.
Investigational drugs: BT-001 is an experimental oncolytic virus therapy designed to stimulate the immune system to attack cancer cells by being injected directly into tumors. Pembrolizumab is an immune checkpoint inhibitor that blocks a protein on immune cells, allowing them to better recognize and destroy cancer cells.
Study of Pembrolizumab with Cisplatin or Carboplatin and Etoposide for Patients with Advanced Merkel Cell Carcinoma
This Italian trial is investigating the effectiveness of combining pembrolizumab with chemotherapy drugs cisplatin or carboplatin and etoposide as a first-line treatment for patients with advanced Merkel cell carcinoma. All medications are given as infusions directly into the bloodstream.
Who can participate: You must be at least 18 years old and have a confirmed diagnosis of locally advanced, relapsed, or metastatic Merkel cell carcinoma that can be measured on scans. You should not have received any previous systemic therapy for your advanced disease. You need to have adequate blood, liver, and kidney function, and be able to carry out light work or be fully active. A tumor sample must be available for testing, and you must have a life expectancy of at least 3 months. Women of childbearing potential must use effective contraception and have a negative pregnancy test.
Who cannot participate: The trial excludes patients who have already received treatment for Merkel cell carcinoma, those with other active cancers requiring treatment, patients with serious uncontrolled medical conditions, pregnant or breastfeeding women, those with known allergies to the study drugs, patients with active infections requiring treatment, and those who have received a live vaccine within 30 days prior to the study.
What the trial aims to do: The study aims to evaluate how well this combination of medications works as a first-line treatment and to monitor any side effects that may occur. Researchers will assess the overall response of the cancer to the treatment and track the occurrence of any adverse events throughout the study period.
Investigational drugs: Pembrolizumab is an immunotherapy that helps the immune system recognize and attack cancer cells. Cisplatin and carboplatin are chemotherapy drugs that damage cancer cell DNA to stop them from growing and dividing. Etoposide is a chemotherapy medication that interferes with cancer cell DNA repair mechanisms, preventing them from multiplying.
Study on Reduced Dose Intensity of Pembrolizumab and Drug Combination for Patients with Advanced or Metastatic Cancer Responding to Standard Immunotherapy
This French trial is studying whether patients with various types of advanced cancer, including Merkel cell carcinoma, who have responded well to standard immunotherapy for six months can continue treatment with a reduced dose given every three months instead of the standard schedule. The study involves several immunotherapy medications including pembrolizumab, durvalumab, avelumab, nivolumab, dostarlimab, atezolizumab, and cemiplimab.
Who can participate: You must be at least 18 years old and have metastatic or locally advanced cancer that has shown a partial or complete response after 6 months of standard immunotherapy treatment. You need to be eligible to continue the same immunotherapy treatment and have an ECOG performance status of 0 or 1, meaning you are fully active or have some symptoms but can still do light work. Both men and women must agree to use reliable birth control during the study. You must be willing and able to follow the study rules, including attending all scheduled visits.
Who cannot participate: The trial excludes patients who have not shown a response to treatment after 6 months of standard immunotherapy. Specifically, patients with melanoma who have not shown a partial response are not eligible. Patients who have been treated with certain drug combinations and have not shown a response are also excluded.
What the trial aims to do: The main goal is to determine whether a reduced dose of immunotherapy given every three months is as effective as the standard dose in preventing cancer progression. The study will last for up to three years and will also assess quality of life and any side effects experienced by participants.
Investigational drugs: Checkpoint inhibitors are a type of immunotherapy that works by blocking proteins that prevent the immune system from attacking cancer cells, thereby enhancing the body’s immune response against tumors. This trial tests whether a reduced dose intensity can maintain the same effectiveness while potentially reducing side effects.
Study of Retifanlimab Combined with Carboplatin, Cisplatin and Etoposide Before Surgery in Patients with Resectable Merkel Cell Carcinoma
This Italian study is testing a short course of combined chemotherapy and immunotherapy given before surgery in patients with Merkel cell carcinoma that can be surgically removed and has not spread to other organs. The treatment involves one cycle of retifanlimab combined with platinum-based chemotherapy and etoposide, followed by surgery to remove the tumor.
Who can participate: You must be at least 18 years old with a confirmed diagnosis of Merkel cell carcinoma that can be surgically removed. You should not have received any previous systemic treatment or radiation therapy before surgery. You need to be able to perform daily activities independently or with minimal assistance and be willing to attend scheduled appointments. You must provide tumor tissue samples for analysis and have adequate blood test results showing proper blood cell counts, kidney function, and liver function. Women who can become pregnant must have a negative pregnancy test and use effective birth control during the study and for 180 days after. Men must also use effective birth control during the study and for 6 months after.
Who cannot participate: The trial excludes patients who have received previous treatment for Merkel cell carcinoma, those with cancer that has spread to other organs, patients with tumors that cannot be removed by surgery, those with a history of autoimmune diseases, patients with active or chronic infections including hepatitis B, hepatitis C, or HIV, those with severe heart conditions in the past 6 months, pregnant or breastfeeding women, patients with known allergies to the study medications, and those who had major surgery within 4 weeks before starting the study.
What the trial aims to do: The study aims to test how well a short course of combined chemotherapy and immunotherapy works when given before surgery. After surgery, doctors will examine the removed tumor tissue to determine if any cancer cells remain. The study will also assess the safety of the treatment, its effects on quality of life, and how it affects the cancer cells and the body’s immune system.
Investigational drugs: Retifanlimab is an immunotherapy medication that helps the immune system fight cancer cells by blocking certain proteins that prevent immune system attacks. Etoposide is a chemotherapy medication that stops cancer cells from growing and dividing. Platinum-based drugs such as cisplatin or carboplatin are chemotherapy medications that damage cancer cell DNA, preventing them from multiplying.
Summary
All four clinical trials for neuroendocrine carcinoma of the skin are taking place in European countries, with Italy hosting two trials and France and Belgium each participating in trials. A notable pattern across these studies is the focus on combining immunotherapy with chemotherapy to improve treatment outcomes. Three of the four trials involve pembrolizumab, a well-established immunotherapy medication, either alone or in combination with chemotherapy drugs. The trials cover different stages of the disease, from surgically removable tumors to advanced and metastatic cases, offering treatment options for patients at various points in their cancer journey. The studies also reflect an emerging trend in cancer treatment research: testing whether lower doses of effective medications can maintain benefits while reducing side effects, as seen in the French trial examining reduced dose intensity of immunotherapy. These trials represent important opportunities for patients with this rare and aggressive form of skin cancer to access novel treatment approaches that may not yet be available outside of clinical research settings.
