Azienda Ospedaliera Universitaria Senese
Siena, Italy
RecruitingRare disease
Study of Pembrolizumab with Cisplatin or Carboplatin and Etoposide for Patients with Advanced Merkel Cell Carcinoma
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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 type of skin cancer called Merkel cell carcinoma (MCC), which is known to be aggressive and can spread quickly. The study is investigating the effectiveness of a treatment combination that includes the medication pembrolizumab, also known by its brand name KEYTRUDA, along with chemotherapy drugs cisplatin or carboplatin, and etoposide. These medications are given as infusions, which means they are administered directly into the bloodstream through a vein.
The purpose of the study is to evaluate how well this combination of medications works as a first-line treatment for patients who have not received prior systemic therapy for their advanced MCC. The study is designed to observe the response of the cancer to the treatment and to monitor any side effects that may occur. Participants will receive the treatment over a period of time, and their health will be closely monitored by the research team.
Throughout the study, the research team will assess the overall response of the cancer to the treatment, as well as track the occurrence of any adverse events, which are unwanted effects that may happen during the study. The study aims to provide valuable information on the potential benefits and risks of using this combination of medications for treating advanced Merkel cell carcinoma.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
16 criteria
- Patients must be capable of giving signed informed consent, meaning they understand the study and agree to participate.
- No previous systemic therapy for advanced disease, which means patients should not have received treatments that affect the whole body for their advanced condition.
- Patients with treated or asymptomatic brain metastases may be enrolled. Brain metastases are cancer cells that have spread to the brain, and asymptomatic means they are not causing symptoms.
- Women of childbearing potential must use 2 effective methods of contraception with a failure rate of less than 1% per year during the study and for 5 months after the last dose, or agree to practice true abstinence. They must have a negative pregnancy test during the screening period.
- Adequate haematological function is required, which means having a healthy blood cell count: white blood cells (WBC) ≥ 2,500/mm³, absolute neutrophil count (ANC) ≥ 1,500/mm³, platelet count ≥ 100,000/mm³, and haemoglobin ≥ 9 g/dL.
- Adequate hepatic function is needed, meaning the liver is working well: total bilirubin ≤ 1.5 times the upper limit of normal (ULN), and liver enzymes ALT and AST ≤ 2.5 times ULN (or ≤ 5 if due to liver metastases).
- Adequate renal function is required, meaning the kidneys are working well: serum creatinine ≤ 1.5 times ULN or an estimated creatinine clearance of ≥ 30 mL/minute.
- Stable medical condition, meaning no worsening of chronic illnesses, serious infections, or major surgery within 4 weeks before registration.
- Ability to comply with protocol requirements, meaning patients can follow the study rules and procedures.
- Patients must be at least 18 years old at the time of signing the informed consent form.
- Locally advanced, relapsed, or metastatic MCC stage IIIB-IV according to the American Joint Committee on Cancer (AJCC) TNM Staging Classification for Merkel Cell Carcinoma (8th edition, 2017).
- Histologically confirmed diagnosis of MCC, meaning the cancer has been confirmed by examining tissue under a microscope.
- Availability of a tumor sample (from a core biopsy or surgical specimen) is mandatory for PD-L1 expression assessment and biomolecular characterization.
- Life expectancy of at least 3 months.
- Measurable disease per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1), meaning the cancer can be measured on scans.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, which indicates the patient is fully active or has some symptoms but can carry out light work.
Who cannot join the trial?
7 criteria
- Patients who have already received treatment for their Merkel cell carcinoma cannot participate. This means if you have had any previous therapy for this type of cancer, you are not eligible.
- Patients with other active cancers that require treatment are not eligible. This means if you have another type of cancer that is currently being treated, you cannot join the study.
- Patients with serious, uncontrolled medical conditions are excluded. This refers to any major health issues that are not being managed well, such as severe heart disease or uncontrolled diabetes.
- Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
- Patients with known allergies to the study drugs or similar drugs are not eligible. If you have had allergic reactions to similar medications in the past, you cannot join the study.
- Patients with active infections that require treatment are excluded. This means if you have an infection that needs medical treatment, you cannot participate.
- Patients who have received a live vaccine within 30 days prior to the study cannot participate. Live vaccines are those that contain a version of the living virus or bacteria that has been weakened.
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Verified sites
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Responsive Verified Centro Ricerche Cliniche Di Verona S.r.l.
Verona, ItalyResponsive Istituto Europeo Di Oncologia S.r.l.
Milan, Italy
Trial locations
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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 used to help treat advanced Merkel cell carcinoma, a type of skin cancer, by boosting your body's natural defenses against the cancer.
Cisplatin
is a chemotherapy drug that helps kill cancer cells. It works by damaging the DNA inside the cancer cells, which stops them from growing and dividing. In this trial, cisplatin is used in combination with other treatments to help fight advanced Merkel cell carcinoma.
Carboplatin
is another chemotherapy medication similar to cisplatin. It also works by damaging the DNA of cancer cells, preventing them from multiplying. Carboplatin is used in this trial as part of a combination treatment to help manage advanced Merkel cell carcinoma.
Etoposide
is a chemotherapy drug that helps stop cancer cells from growing. It works by interfering with the DNA of the cancer cells, which prevents them from dividing and spreading. In this trial, etoposide is used alongside other treatments to help treat advanced Merkel cell carcinoma.
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 being studied in clinical trials for its effectiveness in treating advanced Merkel cell carcinoma, a rare type of skin cancer. The main therapeutic use of pembrolizumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-1 on immune cells, which helps the immune system to better detect and destroy cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.
Investigated diseases
Merkel Cell Carcinoma – Merkel Cell Carcinoma is a rare and aggressive form of skin cancer that originates from Merkel cells, which are found in the skin's outer layer. It typically appears as a painless, firm, and fast-growing nodule on sun-exposed areas of the skin, such as the face, neck, and arms. The disease progresses rapidly, often spreading to nearby lymph nodes and distant parts of the body. As it advances, it can invade deeper skin layers and other tissues. The progression of Merkel Cell Carcinoma is characterized by its tendency to metastasize early, making it challenging to manage. Understanding its progression is crucial for developing effective treatment strategies.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-500988-12-00Protocol codePANDORAEstimated enrolment35 patientsSponsorFondazione IRCCS Istituto Nazionale Dei Tumori
sourced from the EU Clinical Trials Register and site verification
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