Not recruiting

Study on the Safety of Avelumab, Lorlatinib, and Axitinib for Cancer Patients Continuing from Previous Trials

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 clinical trial is focused on studying the effects of certain medications on Cancer. The medications being tested include AVELUMAB, LORLATINIB, AXITINIB, and TALAZOPARIB. AVELUMAB is a human antibody that targets a protein called PD-L1, which is involved in the immune system's response to cancer. LORLATINIB is a small molecule that inhibits specific proteins known as ALK and ROS1 kinases, which can be involved in cancer growth. AXITINIB is a selective inhibitor of vascular endothelial growth factor (VEGF) receptors, which play a role in the formation of blood vessels that supply tumors. TALAZOPARIB is a potent, orally available small molecule that inhibits PARP, a protein involved in DNA repair.

The purpose of this study is to monitor the safety and tolerability of these treatments. Participants in this study will continue to receive the study medications they were already taking in previous trials. The study will involve regular visits to monitor the participants' health and any side effects they may experience. The study is open-label, meaning both the participants and the researchers know which treatment is being administered. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual drugs.

The study will last for a period of up to 60 months, during which participants will be closely monitored for any adverse effects or serious adverse events. The goal is to ensure that the treatments are safe and to gather more information about their effects on cancer. Participants will be required to follow specific guidelines and attend scheduled visits as part of the study protocol. This trial is part of a larger effort to understand and improve cancer treatments using these medications.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant must be currently receiving treatment and experiencing significant clinical benefit from a previous Avelumab study.
The participant must agree to follow specific reproductive criteria and be willing to comply with all scheduled visits and procedures.
Step 2
Treatment phase
The participant will continue receiving the study medications, which include lorlatinib, avelumab, axitinib, and talazoparib.
Lorlatinib, axitinib, and talazoparib are administered orally. Avelumab is administered through intravenous use.
The specific dosage and frequency of each medication will be determined by the study protocol and the participant's response to treatment.
Step 3
Monitoring and follow-up
The main objective of the study is to monitor the safety and tolerability of the treatments.
Participants will be regularly monitored for any adverse events (AEs) or serious adverse events (SAEs) that may lead to discontinuation of the study intervention.
The study is estimated to continue until September 30, 2026, with regular follow-up visits scheduled as per the study protocol.

Who can join the trial?

5 criteria

Participants must have **cancer** and be receiving treatment that is part of a specific study, showing significant benefit from it, or be in a follow-up period for safety or survival.
Participants must agree to follow specific guidelines related to reproduction, which are detailed in the study's protocol.
Participants should be willing and able to attend all scheduled visits, follow the treatment plan, and participate in other study procedures as required by the study protocol.
Participants must be able to understand and sign a document called **informed consent**, which explains the study's requirements and restrictions.
Both **male** and **female** participants are eligible to join the study.

Who cannot join the trial?

9 criteria

Patients who are currently receiving treatment for **cancer** cannot participate. **Cancer** is a disease where cells in the body grow uncontrollably.
Individuals who are under the age of 18 are not eligible to join the study.
Pregnant or breastfeeding women are excluded from participating in the trial.
Participants who have a history of severe allergic reactions to any of the study medications are not allowed to join.
People with significant heart problems, such as heart failure or recent heart attacks, cannot take part in the study. **Heart failure** is when the heart doesn't pump blood as well as it should.
Individuals with uncontrolled high blood pressure are excluded. **High blood pressure** means the force of the blood against the artery walls is too high.
Patients with severe liver or kidney disease are not eligible. The **liver** and **kidneys** are organs that help filter and clean the blood.
Anyone who has participated in another clinical trial within the last 30 days is not allowed to join this study.
People with a history of drug or alcohol abuse in the past year are excluded from the trial.

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Verified sites

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

Aalborg University Hospital
Verified
Aalborg, Denmark
Grand Hopital De Charleroi
Responsive
Charleroi, Belgium
Institut De Cancerologie De Lorraine
Responsive
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Avelumab is a medication used in this clinical trial. It is an immunotherapy drug that helps the body's immune system to fight cancer cells. Avelumab works by blocking a protein that prevents the immune system from attacking cancer cells, allowing the immune system to better target and destroy them. This study aims to monitor the safety and tolerability of Avelumab in participants who are continuing from previous studies.

What is already known about the treatment

Avelumab – Avelumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials, particularly for its safety and tolerability in patients with cancer. The main therapeutic indication for Avelumab is the treatment of certain types of cancer. At the molecular level, Avelumab works by blocking a protein called PD-L1, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses to fight cancer.

Investigated diseases

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells. These cells can invade nearby tissues and form tumors, which may disrupt the normal function of organs. As cancer progresses, it can spread to other parts of the body through the bloodstream or lymphatic system, a process known as metastasis. The progression of cancer varies depending on the type and location of the cancer, as well as individual factors. Some cancers grow slowly and may not cause symptoms for a long time, while others can grow rapidly and cause significant health issues. The behavior and progression of cancer are influenced by genetic, environmental, and lifestyle factors.