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Study Comparing ANV419 and High Dose IL2 in Adoptive Cell Therapy for Patients with Melanoma, Non-Small Cell Lung Cancer, and Cervical Cancer

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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 advanced solid tumors, specifically melanoma, non-small cell lung cancer (NSCLC), and cervical cancer. The study is evaluating a new treatment approach called Adoptive Cell Therapy (ACT) using a special type of immune cells known as Tumor Infiltrating Lymphocytes (TIL). These cells are collected from the patient's own tumor and are used to help the immune system fight cancer. The trial compares two treatments: one using a new drug called ANV419, which is an IL-2 analog, and the other using high doses of a substance called interleukin-2 (IL-2).

The purpose of the study is to see if using ANV419 can reduce certain side effects that are commonly associated with IL-2 treatment. The study will also look at how these treatments affect patients' quality of life and their own reports of symptoms. Participants will receive either the new drug ANV419 or high-dose IL-2 after their TIL therapy. The study will monitor the patients for any side effects and changes in their condition over time.

Throughout the study, patients will undergo regular assessments to track their response to the treatment and any changes in their health. The trial aims to provide valuable information on the effectiveness and safety of using ANV419 compared to high-dose IL-2 in treating these types of cancer. This research could lead to improved treatment options for patients with advanced melanoma, NSCLC, and cervical cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initiation of treatment
Upon joining the study, the treatment begins with the administration of fludarabine phosphate. This medication is given as an intravenous (IV) injection or infusion. The purpose of this step is to prepare the body for the subsequent treatments.
Step 2
Administration of cyclophosphamide
Following the initial treatment, cyclophosphamide monohydrate is administered. This is also given as a solution for injection or infusion. The goal is to further prepare the body for the main treatment phase.
Step 3
Tumor-infiltrating lymphocytes (TIL) therapy
The main treatment involves the infusion of autologous tumor-infiltrating lymphocytes (TIL). These are special immune cells that have been extracted, grown, and prepared to help fight the cancer. This step is crucial for targeting the cancer cells directly.
Step 4
Interleukin-2 (IL-2) therapy
After TIL therapy, interleukin-2 (IL-2) is administered. This can be given either intravenously or subcutaneously. The purpose of IL-2 is to support the growth and activity of the TILs, enhancing their ability to attack cancer cells.
Step 5
Monitoring and follow-up
Throughout the treatment, regular monitoring is conducted to assess the body's response and manage any side effects. This includes tracking symptoms and overall health status to ensure the treatment is proceeding safely and effectively.
Step 6
Evaluation of treatment outcomes
At the end of the treatment cycle, an evaluation is performed to determine the effectiveness of the therapy. This involves measuring changes in tumor size and assessing overall health improvements.

Who can join the trial?

18 criteria

Patients must have a confirmed diagnosis of advanced melanoma, non-small cell lung cancer (NSCLC), or cervical cancer that cannot be removed by surgery or has spread to other parts of the body. The disease must have worsened after at least one standard treatment, or the patient cannot or does not want to receive standard treatment.
Patients must have lung function test results showing at least 50% of normal lung capacity.
Patients must test negative for HIV, as those with HIV may not respond well to the treatment and could experience more side effects.
Patients must test negative for active hepatitis B and hepatitis C. Those with a past hepatitis B infection must have specific test results to be eligible. Patients with hepatitis C must have a negative test for the virus.
Patients must have a life expectancy of at least 3 months.
Patients who can have children or have partners who can have children must agree to use effective birth control during the study and for 6 months after the last treatment dose.
Female participants must not be pregnant or breastfeeding and must meet specific conditions regarding their ability to have children, including using effective birth control and having a negative pregnancy test before starting the study.
Male participants must agree to use birth control methods or remain abstinent during the study and for 2 months after the last treatment dose. They must also agree not to donate sperm during this time.
Any side effects from previous treatments must have improved to a mild level at least 4 weeks before joining the study, except for certain conditions like hair loss or skin changes.
Patients may have had minor surgeries in the past 3 weeks, as long as they have recovered from any side effects.
Patients must have at least one tumor or metastasis that can be removed or biopsied for study purposes, with minimal risk.
Patients must have remaining measurable disease after tumor removal or biopsy, according to specific criteria.
Patients must be at least 18 years old at the time of tissue collection for the study.
Patients must understand and voluntarily sign a consent form before any study-related procedures.
Patients must be willing and able to follow the study schedule and requirements.
Patients must have a good performance status, meaning they can carry out daily activities with little or no assistance.
Patients must be medically fit for all study procedures and have adequate blood, kidney, and liver function, as defined by specific test results.
Patients must have a heart function test showing at least 45% of normal heart capacity.

Who cannot join the trial?

10 criteria

Patients with other types of cancer not specified in the study, such as those not having melanoma, non-small cell lung cancer (NSCLC), or cervical cancer.
Patients who have medical conditions that could interfere with the study treatment or its evaluation.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who have participated in another clinical trial recently, which might affect the results of this study.
Patients who are pregnant or breastfeeding, as the study treatment might affect the baby.
Patients with a history of severe allergic reactions to any of the study medications.
Patients with certain heart conditions that could be worsened by the study treatment.
Patients with active infections that require treatment, as this could interfere with the study.
Patients with a history of other serious medical conditions that could affect their safety during the study.
Patients who are unable to provide informed consent, which means they cannot understand the study and agree to participate.

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Verified sites

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

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Herlev Hospital
Herlev, Denmark
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Hospital Vall d’Hebron
Barcelona, Spain

Trial locations

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Investigated drugs

ANV419
is an IL-2 analog being studied for its potential to reduce severe side effects associated with interleukin use in cancer treatment. It is being compared to traditional high-dose IL-2 therapy to see if it can improve patient outcomes while minimizing adverse events.
High-dose IL-2
is a standard treatment used after Tumor Infiltrating Lymphocytes (TIL) therapy in patients with certain types of cancer, such as melanoma, non-small cell lung cancer (NSCLC), and cervical cancer. It helps to boost the immune system to fight cancer cells but can cause significant side effects.

What is already known about the treatment

ANV419 – ANV419 is administered as an injection and is currently being studied in clinical trials for its potential use in treating advanced solid tumors, including melanoma, non-small cell lung cancer, and cervical cancer. It is an IL-2 analog, which means it is designed to mimic the action of interleukin-2, a protein that plays a role in the immune system. The main therapeutic indication for ANV419 is to enhance the effectiveness of adoptive cell therapy, specifically tumor-infiltrating lymphocyte therapy, by potentially reducing severe side effects associated with traditional high-dose interleukin-2 treatments. ANV419 works by stimulating the immune system to attack cancer cells more effectively, and it is classified as an immunotherapy agent.

Investigated diseases

Melanoma
Melanoma is a type of skin cancer that begins in the melanocytes, the cells responsible for producing melanin, the pigment that gives skin its color. It often appears as a new mole or a change in an existing mole, with irregular borders and multiple colors. As it progresses, melanoma can grow deeper into the skin and spread to other parts of the body, including lymph nodes and internal organs. Early detection is crucial, as melanoma can be more aggressive than other skin cancers. It is more common in individuals with fair skin and those with a history of sunburns or excessive UV exposure.
Non-Small Cell Lung Cancer (NSCLC)
NSCLC is the most common type of lung cancer, accounting for about 85% of cases. It typically starts in the epithelial cells lining the lungs and can grow slowly or rapidly, depending on the subtype. As the disease progresses, it can invade nearby tissues and spread to other parts of the body, such as the brain, bones, and liver. Symptoms may include a persistent cough, chest pain, and shortness of breath. Smoking is the leading risk factor, but non-smokers can also develop NSCLC due to factors like air pollution and genetic predispositions.
Cervical Cancer
Cervical cancer originates in the cells of the cervix, the lower part of the uterus that connects to the vagina. It often develops slowly, beginning with precancerous changes known as dysplasia, which can be detected through regular screening tests like Pap smears. If untreated, these changes can progress to invasive cancer, spreading to nearby tissues and organs. Human papillomavirus (HPV) infection is the primary cause of cervical cancer, with certain strains posing a higher risk. Symptoms may include abnormal vaginal bleeding, pelvic pain, and pain during intercourse.