Naevoid melanoma Trials in Disease

Study on the Safety and Effects of ATL001 and Nivolumab for Adults with Metastatic or Recurrent Melanoma

This clinical trial is investigating a new treatment approach for patients with metastatic or recurrent melanoma, which means the cancer has spread to other parts of the body or has returned after previous treatment.

Who can participate:

• Adults aged 18 years or older
• Patients with confirmed metastatic or recurrent melanoma through tissue biopsy
• Life expectancy of at least 6 months at the time of tissue collection
• Measurable disease that can be tracked during the study
• Previous treatment with a PD-1/PD-L1 inhibitor medication with disease progression or stable disease after at least 4 doses
• Patients with BRAF V600 mutation must have previously received targeted therapy for this mutation
• Performance status of 0-1, meaning ability to carry out normal daily activities with minimal or no assistance
• Adequate organ function confirmed by blood tests
• Willingness to use effective birth control during the study and for several months after treatment

Who cannot participate:

• Patients with other types of cancer besides metastatic or recurrent melanoma
• Pregnant or breastfeeding women
• Patients unable to provide informed consent
• Those currently participating in another clinical trial
• Patients who have had recent major surgery or are still recovering
• History of severe allergic reactions to similar treatments
• Active infection requiring treatment
• Certain medical conditions that might interfere with the study or worsen with treatment
• History of substance abuse that could affect study participation

What the trial involves:

The study is testing a personalized treatment called ATL001, which is a type of cell therapy. This therapy uses the patient's own immune cells, specifically T cells, which are modified to better recognize and attack cancer cells. The treatment is designed to target unique markers found on the cancer cells.

ATL001 is being tested both alone and in combination with nivolumab (brand name OPDIVO). Nivolumab is a medication that helps the immune system fight cancer by blocking a protein called PD-1 that normally stops the immune system from attacking cancer cells. By blocking this protein, nivolumab enhances the immune response against cancer.

The trial process involves several steps:

1. Initial assessment with medical history review and physical examination
2. Tissue collection from the tumor (which may require general anesthesia) to manufacture the personalized ATL001 treatment
3. Lymphodepletion – administration of medications (fludarabine and cyclophosphamide) to reduce the number of immune cells in the body before treatment
4. Administration of ATL001 through intravenous infusion
5. For some patients, combination treatment with nivolumab, also given intravenously
6. Regular follow-up visits with physical examinations, imaging tests, and laboratory tests to monitor response to treatment and check for side effects

Purpose of the study:

The main goals of this trial are to evaluate the safety of ATL001 when used alone and in combination with nivolumab, and to determine how well these treatments work in controlling metastatic or recurrent melanoma. Researchers will monitor changes in tumor size, overall survival rates, and quality of life for participants. The study aims to develop new ways to treat advanced melanoma and potentially improve outcomes for patients affected by this disease.

The study is expected to continue until July 31, 2027, though individual participation may end earlier if the treatment protocol is completed or if necessary for medical reasons.