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

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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 metastatic or recurrent melanoma. The study is testing a new treatment approach using a personalized therapy called ATL001, which is a type of cell therapy. This therapy involves using the patient's own immune cells, specifically T cells, which are modified to better recognize and attack cancer cells. The study also involves a medication called nivolumab, which is known by the brand name OPDIVO. Nivolumab is a type of drug that helps the immune system fight cancer by blocking a protein that stops the immune system from attacking cancer cells.

The purpose of this study is to evaluate the safety and how well the treatment works when using ATL001 alone and in combination with nivolumab. Participants in the study will receive these treatments through an infusion, which means the medication is given directly into the bloodstream through a vein. The study will monitor participants over a period of time to observe any side effects and to see how the cancer responds to the treatment. The study aims to understand if this combination can help control the cancer and improve outcomes for patients with metastatic or recurrent melanoma.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the effects of the treatment. The study will also look at changes in the size of the tumor and overall survival rates. This research is important for developing new ways to treat melanoma and potentially improve the quality of life for those affected by this disease.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
Blood and tumor tissue samples are collected to ensure the patient meets the study criteria.
Step 2
Tissue procurement
A procedure is performed to collect tissue from the tumor. This may require a general anesthetic.
The collected tissue is used to manufacture a personalized treatment called ATL001.
Step 3
Lymphodepletion
Before receiving ATL001, a process called lymphodepletion is carried out. This involves administering medications to reduce the number of immune cells in the body.
Medications used include fludarabine and cyclophosphamide, given according to the protocol's schedule.
Step 4
Administration of ATL001
ATL001 is administered as an infusion. This is a personalized therapy targeting specific mutations in cancer cells.
The infusion is given intravenously, meaning it is delivered directly into the bloodstream.
Step 5
Combination therapy with nivolumab
In some cases, ATL001 is given in combination with another medication called nivolumab.
Nivolumab is also administered intravenously and is used to help the immune system attack cancer cells.
Step 6
Monitoring and follow-up
Regular follow-up visits are scheduled to monitor the patient's response to treatment and to check for any side effects.
These visits include physical examinations, imaging tests, and laboratory tests to assess the patient's health and the effectiveness of the treatment.
Step 7
End of study participation
The study is expected to continue until July 31, 2027. Participation may end earlier if the patient completes the treatment protocol or if it is deemed necessary for medical reasons.
Upon completion, a final assessment is conducted to evaluate the overall response to the treatment.

Who can join the trial?

15 criteria

Patient must be at least 18 years old at the screening visit.
Female patients who can have children must agree to use a very effective method of birth control during the study and for at least 12 months after receiving ATL001. Male patients who are not sterilized and plan to be sexually active with a female partner who can have children must use an acceptable method of birth control from the time of screening, throughout the study, and for at least 6 months after receiving ATL001.
Patients must have metastatic or recurrent melanoma, which means the cancer has spread or returned after treatment.
Patients must have a life expectancy of at least 6 months at the time of tissue collection.
Patients must have measurable disease according to specific criteria before certain treatments.
Patients must be considered well enough by the study doctor to receive ATL001 treatment, which will be checked before certain treatments.
Before treatment with ATL001, patients must have received a type of medication called a PD-1/PD-L1 inhibitor and experienced either disease progression or stable disease after at least 4 doses.
Female patients in a specific group must agree to use effective birth control during treatment with nivolumab and for at least 5 months after the last dose. They must also agree to take a pregnancy test before each nivolumab dose during the treatment period.
Patient must have given written informed consent to participate in the study.
Patients must have a confirmed diagnosis of melanoma through a tissue sample.
Patients whose tumor has a specific mutation called BRAF V600 must have received targeted therapy for this mutation, as well as a PD-1/PD-L1 inhibitor, unless they cannot take it.
Patient must be medically fit to undergo all study procedures and treatments, including blood and tumor tissue collection, and receive specific medications at the required doses and schedules.
Patient must be considered capable of following the study protocol by the study doctor.
Patient must have a performance status of 0-1, which means they are fully active or have some symptoms but do not need help with daily activities.
Patient must have adequate organ function, shown by specific blood test results, to ensure they can safely participate in the study.

Who cannot join the trial?

10 criteria

Patients with other types of cancer besides **metastatic or recurrent melanoma** cannot participate. **Metastatic** means the cancer has spread to other parts of the body, and **recurrent** means the cancer has come back after treatment.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
Patients who are not able to give informed consent, which means they cannot understand the study and agree to participate, are excluded.
Patients who are pregnant or breastfeeding cannot participate, as the study may affect the baby.
Patients with certain medical conditions that might interfere with the study or be worsened by the study treatment are excluded.
Patients who are currently participating in another clinical trial cannot join this study.
Patients who have had a recent major surgery or are recovering from a major surgery are excluded.
Patients with a history of severe allergic reactions to similar treatments are not allowed to participate.
Patients who have an active infection that requires treatment are excluded.
Patients with a history of substance abuse that might interfere with the study are not allowed to participate.

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Verified sites

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Verified
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain

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Investigated drugs

ATL001
is a type of therapy that uses special immune cells called T cells. These T cells are designed to recognize and attack cancer cells in patients with melanoma, a type of skin cancer. The goal of using ATL001 is to see if it is safe for patients and if it can help fight the cancer.
Nivolumab
is a medication that helps the immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells. In this trial, nivolumab is used in combination with ATL001 to see if the two treatments together are more effective in treating melanoma.

What is already known about the treatment

ATL001
This medication is administered through infusion, typically in a clinical setting. It is currently being studied in clinical trials for its safety and effectiveness in treating metastatic or recurrent melanoma. The main therapeutic indication is for patients with advanced melanoma, where it aims to enhance the immune system's ability to target and destroy cancer cells. At the molecular level, ATL001 works by activating T cells that are specifically reactive to neoantigens, which are unique markers found on cancer cells. It is classified as an immunotherapy agent, focusing on boosting the body's natural defenses to fight cancer.
Nivolumab
This medication is given as an intravenous infusion, usually in a hospital or clinic. It is an established treatment in the medical field, particularly for various types of cancer, including melanoma. Nivolumab is used to help the immune system recognize and attack cancer cells, making it effective for patients with metastatic or recurrent melanoma. Its mechanism of action involves blocking a protein called PD-1 on T cells, which enhances the immune response against cancer cells. Nivolumab is classified as a checkpoint inhibitor, a type of immunotherapy that helps the immune system fight cancer more effectively.

Investigated diseases

Metastatic or recurrent melanoma – This is a type of skin cancer that has spread to other parts of the body or has returned after treatment. It begins in the melanocytes, which are the cells responsible for producing melanin, the pigment that gives skin its color. When melanoma becomes metastatic, it means the cancer cells have traveled through the lymphatic system or bloodstream to distant organs, such as the lungs, liver, or brain. Recurrent melanoma refers to the return of cancer after it has been treated and initially disappeared. The progression of metastatic melanoma can vary, with some cases spreading rapidly, while others may progress more slowly. The disease can cause a variety of symptoms depending on where it spreads, including changes in the skin, pain, or organ dysfunction.