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Study of TIL therapy combined with peginterferon alfa-2a and nivolumab for patients with metastatic melanoma

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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 Metastatic Melanoma, a type of skin cancer that has spread to other parts of the body. The study evaluates a combination treatment approach using several medications. The main treatment involves TIL cells (tumor-infiltrating lymphocytes), which are special immune cells taken from a patient's tumor and grown in a laboratory, along with Peginterferon alfa-2a and nivolumab, which are medications that help the immune system fight cancer.

The research aims to determine if this combination of treatments is safe and how well patients can tolerate it. During the study, participants will receive TIL cells and nivolumab first, followed by the addition of Peginterferon alfa-2a. The study also uses Zirconium Zr 89 crefmirlimab berdoxam, a special imaging substance that helps doctors see how the treatment is working in the body.

Throughout the study, doctors will monitor participants' health closely through regular check-ups, blood tests, and imaging scans. They will track how the cancer responds to treatment and watch for any side effects. The study will continue for several years to gather comprehensive information about how well this treatment combination works for metastatic melanoma patients.

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 assessment
Your eligibility for the study will be evaluated based on medical tests and disease status
Laboratory tests will check your blood parameters including hemoglobin, granulocytes, lymphocytes, and platelets
Viral screening tests must be completed at least 30 days before the procedure
Step 2
Treatment preparation phase
Previous treatments must be discontinued: immunotherapy at least 4 weeks before start, BRAF/MEK inhibitors at least 2 weeks before start
If you have brain metastases, you must be stable for at least 2 months without using dexamethasone
Step 3
Main treatment administration
You will receive TIL cells (tumor-fighting cells) through intravenous infusion
Treatment includes nivolumab administration
Later in the treatment, you will receive PEG-IFNa (peginterferon alfa-2a) in combination with the other medications
Step 4
Monitoring and evaluation
Your condition will be regularly monitored through physical examinations
Imaging studies (CT and/or MRI scans) will be performed to assess your response to treatment
Side effects will be monitored and recorded according to standardized criteria
Quality of life assessments will be conducted throughout the study
Step 5
Follow-up period
Your disease status will be monitored to evaluate the treatment effectiveness
Long-term survival and disease progression will be tracked
The study continues until December 31, 2027

Who can join the trial?

12 criteria

Must be at least 18 years old
Must be willing and able to provide written informed consent
Must have metastatic melanoma (skin cancer that has spread) confirmed by tissue or cell examination
Must have disease that has progressed despite previous treatments like BRAF inhibitors, MEK inhibitors, or immunotherapy
Must have stopped previous treatments for specific periods: - At least 2 weeks for BRAF/MEK inhibitors - At least 4 weeks for immunotherapy
Must have either: - Unremovable stage III melanoma, or - Stage IV melanoma (cancer that has spread) with normal LDH levels (a blood enzyme)
If brain metastases are present, must be neurologically stable for at least 2 months and not using dexamethasone (a steroid medication)
Must have measurable disease that is getting worse
Must have a life expectancy of at least 3 months
Must have good physical function (WHO performance status ≤1)
Must have acceptable blood test results within 2 weeks before starting the study, including: - Adequate blood cell counts - Good kidney function - Acceptable liver function - Normal LDH levels
Must test negative for certain viruses at least 30 days before surgery: - HIV - HTLV - Syphilis - Hepatitis B - Hepatitis C

Who cannot join the trial?

14 criteria

Age under 18 years or over 75 years
History of autoimmune diseases (conditions where the immune system attacks healthy body tissues)
Active brain metastases (cancer that has spread to the brain) that are not treated
Presence of active infections, including HIV, hepatitis B, or hepatitis C
Severe heart conditions or uncontrolled high blood pressure
Pregnant or breastfeeding women
Previous organ transplant recipients
Current participation in other clinical trials
Severe kidney or liver dysfunction
History of other cancers in the past 3 years (except for successfully treated non-melanoma skin cancer)
Mental conditions that could interfere with following study procedures
Known allergic reactions to study medications
Use of systemic steroids or other immunosuppressive medications
Life expectancy less than 3 months

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Verified sites

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Leids Universitair Medisch Centrum (LUMC)
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Leiden, The Netherlands

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Investigated drugs

TIL (Tumor Infiltrating Lymphocytes)
is a type of cell therapy where immune cells are taken from a patient's tumor, grown in a laboratory, and then given back to the patient. These cells are specially trained to recognize and fight cancer cells.
Nivolumab
is a medication that helps the immune system fight cancer. It works by blocking a protein that normally prevents the immune system from attacking cancer cells, allowing the body's natural defenses to work better against melanoma.
PEG-IFNa (Pegylated Interferon alpha)
is a modified form of interferon, a protein that helps regulate immune system activity. It is designed to stay active in the body longer than regular interferon and helps boost the body's natural ability to fight cancer cells.

What is already known about the treatment

Nivolumab
A prescription immunotherapy medication administered through intravenous infusion that belongs to the class of PD-1 inhibitors. This drug works by helping the immune system recognize and attack cancer cells by blocking the PD-1 protein on T cells, which is particularly effective in treating metastatic melanoma. It is currently approved by major medical authorities and widely used in cancer treatment, with extensive documentation in medical literature supporting its efficacy.
PEG-IFNa (Pegylated Interferon alpha)
A long-acting form of interferon alpha that is administered through subcutaneous injection, created by attaching a polyethylene glycol molecule to the interferon protein. This medication works by enhancing the body's immune response against cancer cells and has demonstrated effectiveness in treating various cancers, including melanoma. The pegylated form allows for less frequent dosing while maintaining therapeutic levels in the body, making it more convenient for patients compared to standard interferon.
TIL (Tumor-Infiltrating Lymphocytes)
A form of cell therapy where immune cells are extracted from a patient's tumor, grown and multiplied in a laboratory, and then reinfused back into the patient through intravenous administration. This personalized treatment approach uses the patient's own immune cells that have naturally found their way into the tumor tissue, enhancing their ability to recognize and fight cancer cells when reintroduced in larger numbers. TIL therapy represents an advanced form of immunotherapy with promising results in treating metastatic melanoma.

Investigated diseases

Metastatic Melanoma - A serious form of skin cancer that has spread from its original location to other parts of the body. It begins in melanocytes, the cells that produce melanin, which gives skin its color. When melanoma spreads (metastasizes), it commonly affects lymph nodes, lungs, liver, bones, and brain. The condition typically starts as changes in existing moles or the appearance of new, unusual skin growths. Metastatic melanoma develops when cancer cells break away from the primary tumor and travel through lymphatic vessels or bloodstream to form new tumors in distant areas.