Not recruitingRare disease

Study of Retifanlimab Combined with Carboplatin, Cisplatin and Etoposide Before Surgery in Patients with Resectable Merkel Cell Carcinoma

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Merkel Cell Carcinoma that can be removed by surgery and has not spread to other organs. The treatment combines several medications: retifanlimab (also known as ZYNYZ), which is given together with chemotherapy drugs including carboplatin or cisplatin, and etoposide. All medications are given through an intravenous infusion into a vein.

The purpose of this study is to test how well a short course of combined chemotherapy and immunotherapy works when given before surgery in patients with Merkel Cell Carcinoma. The treatment involves one cycle of therapy followed by an operation to remove the tumor. During the treatment, patients will receive the medications through intravenous infusions at specified doses.

After the surgery is completed, doctors will examine the removed tumor tissue to determine if any cancer cells remain. The study will also look at how safe the treatment is and how it affects patients' quality of life. Researchers will collect blood samples and tumor tissue to study how the treatment affects the cancer cells and the body's immune system.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will receive a combination of medications through intravenous infusion. The treatment includes:
- Retifanlimab (ZYNYZ 500 mg)
- Platinum-based chemotherapy (either cisplatin or carboplatin)
- Etoposide
This treatment consists of one cycle before surgery.
Step 2
Surgery
After completing the medication cycle, you will undergo surgery to remove the tumor.
The surgical team will remove the tumor and examine nearby lymph nodes.
Step 3
Medical evaluations
Throughout the study, you will undergo regular health assessments including:
- Blood tests to check blood cell counts, liver, and kidney function
- Physical examinations
- Vital signs monitoring
- Heart activity checks (ECG)
- Quality of life questionnaires
Step 4
Follow-up period
After surgery, you will have regular follow-up visits to monitor your recovery and health status.
The study team will track your progress to assess whether the cancer returns.
The total duration of follow-up will continue until the end of 2026.
Step 5
Sample collection
Throughout the study, samples will be collected to analyze your response to treatment:
- Tumor tissue samples before and after treatment
- Blood samples for analysis
These samples help evaluate how well the treatment is working.

Who can join the trial?

16 criteria

Must be at least 18 years old
Must sign an informed consent form
Must have a confirmed diagnosis of Merkel cell carcinoma that can be surgically removed
Must not have received any previous systemic treatment or radiation therapy before surgery
Must be able to perform daily activities independently or with minimal assistance (ECOG status 0-1)
Must be willing to attend scheduled appointments and follow the treatment plan
Must provide tumor tissue samples for analysis
Must have adequate blood test results showing:
- Platelet count of at least 100,000 per microliter
- White blood cell count of at least 1,500 per microliter
- Hemoglobin level of at least 9.0 g/dL
- Must have proper kidney function as shown by blood tests
- Must have proper liver function as shown by blood tests
- For women who can become pregnant:
  - Must have a negative pregnancy test
  - Must use effective birth control during the study and for 180 days after
  - For men:
    
    Must use effective birth control during the study and for 6 months after
    Must not donate sperm during this period

Who cannot join the trial?

13 criteria

Previous treatment with any anti-cancer therapy for Merkel cell carcinoma
Having cancer that has spread to other organs (metastases)
Tumor that cannot be removed by surgery
History of autoimmune diseases (conditions where the immune system attacks healthy cells)
Active or chronic infections including hepatitis B, hepatitis C, or HIV
Severe heart conditions in the past 6 months
Uncontrolled high blood pressure
Pregnant or breastfeeding women
Known allergies to the study medications
Mental conditions that could interfere with following study procedures
Major surgery within 4 weeks before starting the study
Participation in other clinical trials within 4 weeks before this study
Any condition that the doctor believes would make participation unsafe

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Verified
Turin, Italy
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy

Trial locations

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Investigated drugs

Retifanlimab
is an immunotherapy medication that helps the immune system fight cancer cells. It belongs to a group of drugs called immune checkpoint inhibitors, which work by blocking certain proteins that prevent the immune system from attacking cancer cells.
Etoposide
is a chemotherapy medication that works by stopping cancer cells from growing and dividing. It is commonly used in combination with other chemotherapy drugs to treat various types of cancer.
Platinum
(such as cisplatin or carboplatin) is a type of chemotherapy medication that damages the DNA of cancer cells, preventing them from multiplying. It is often used in combination with other chemotherapy drugs to increase effectiveness in treating cancer.

What is already known about the treatment

Retifanlimab
A monoclonal antibody immunotherapy medication administered through intravenous infusion, which belongs to the class of PD-1 inhibitors used in cancer treatment. This medication works by blocking the PD-1 receptor on T-cells, enabling the immune system to better recognize and attack cancer cells, particularly in the treatment of Merkel cell carcinoma. Currently being studied in clinical trials as part of a combination therapy with chemotherapy agents (platinum and etoposide) before surgery in patients with resectable Merkel cell carcinoma, showing promise in the emerging field of chemo-immunotherapy approaches.
Etoposide
A chemotherapy medication administered intravenously that belongs to the topoisomerase inhibitor class of drugs. It works by interfering with cancer cell DNA repair mechanisms, leading to cell death, and is commonly used in combination with platinum-based drugs for treating various types of cancer. In current clinical research, it is being studied as part of a combination therapy with immunotherapy for treating Merkel cell carcinoma before surgical intervention.

Investigated diseases

Merkel Cell Carcinoma - A rare type of skin cancer that typically appears as a flesh-colored or bluish-red nodule on the skin's surface. It usually develops on sun-exposed areas of the body, most commonly on the face, head, or neck. The cancer begins in Merkel cells, which are located at the base of the epidermis and are connected to nerve endings that sense touch. This cancer tends to grow quickly in the skin's top layer and can spread to nearby lymph nodes. Merkel cell carcinoma often appears as a painless, firm bump that can be red, purple, or skin-colored. The condition primarily affects older adults and those with weakened immune systems.