Study of Pembrolizumab with Cisplatin or Carboplatin and Etoposide for Patients with Advanced Merkel Cell Carcinoma

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What is this study about?

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.

1 initial visit

Upon joining the study, you will have an initial visit with the medical team. During this visit, your medical history will be reviewed, and a physical examination will be conducted to ensure you meet the study requirements.

You will be informed about the study procedures, and any questions you have will be answered. You will also be asked to sign an informed consent form, confirming your willingness to participate.

2 treatment initiation

The treatment phase begins with the administration of the study medications. You will receive pembrolizumab, cisplatin or carboplatin, and etoposide through an intravenous infusion. This means the medication will be delivered directly into your bloodstream through a vein.

The specific dosage and frequency of each medication will be determined by the medical team based on your individual health needs and the study protocol.

3 ongoing treatment

You will continue to receive the study medications at regular intervals as determined by the study protocol. The medical team will monitor your response to the treatment and any side effects you may experience.

Regular check-ups and tests will be conducted to assess your health and the effectiveness of the treatment. These may include blood tests, imaging studies, and other assessments as needed.

4 follow-up visits

Throughout the study, you will have scheduled follow-up visits with the medical team. These visits are important for monitoring your progress and addressing any concerns you may have.

During these visits, the medical team will evaluate your overall health, review any side effects, and make any necessary adjustments to your treatment plan.

5 end of treatment

At the end of the treatment period, a final evaluation will be conducted to assess the overall effectiveness of the study medications and your health status.

You will be provided with information on any further follow-up care or additional treatments that may be recommended based on your individual needs.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Awnkhrg Ovbdhojcddj Ucpodpeksfzre Szunzm	Siena	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.09.2023

Trial locations

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.

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 ID:

2022-500988-12-00

Protocol code:

PANDORA

NCT ID:

NCT00000000

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Pembrolizumab with Cisplatin or Carboplatin and Etoposide for Patients with Advanced Merkel Cell Carcinoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?