Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Rare diseases
Investigational molecules
Locations
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying treatments for patients with advanced malignancies, which include both solid tumors and hematological malignancies (cancers that affect the blood, bone marrow, and lymph nodes). The study involves the use of several investigational drugs, including Tislelizumab, Pamiparib, and Ociperlimab. Tislelizumab is administered as a concentrate for solution for infusion, meaning it is given through a vein. Pamiparib is taken orally in capsule form, and Ociperlimab is provided as a solution for infusion.
The purpose of this study is to evaluate the long-term safety of these investigational drugs in patients with advanced cancers. Participants in this study are those who are already part of a related study and continue to benefit from the treatment. The study will monitor the safety of the treatments by observing any side effects, especially those that are serious or affect vital organs like the heart, liver, or brain. The study will also look at overall survival, which is the time from the start of treatment until death from any cause.
During the study, participants will receive the investigational drugs over a period, with the maximum treatment period for some drugs being up to 178 days. The study aims to ensure that the treatments are safe for long-term use and to gather more information on their effects. Participants will be closely monitored throughout the study to ensure their safety and well-being.
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
7 criteria
4 criteria
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Pisa, Italy
Bologna, Italy
Nantes, France
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is a medication used in the trial to help the body's immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells, allowing the immune system to better target and destroy these cells.
is another medication involved in the trial, which is used to treat cancer by interfering with the cancer cells' ability to repair their DNA. This can lead to the death of cancer cells and help slow down or stop the growth of tumors.
are also part of the trial. These are new drugs that are being tested to see how well they work in treating advanced cancers. The specific details of these agents are not provided, but they are being studied to understand their potential benefits and safety in cancer treatment.
Tislelizumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating advanced solid tumors and hematological malignancies. It is an investigational drug, meaning it is still under research and not yet widely available in medical practice. Tislelizumab works by blocking a protein called PD-1 on the surface of immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of medication that enhances the body's immune response against cancer.
Pamiparib is taken orally and is also under investigation in clinical trials for its potential use in treating advanced solid tumors and hematological malignancies. As an investigational drug, it is not yet approved for general medical use. Pamiparib functions by inhibiting an enzyme called PARP, which is involved in repairing damaged DNA in cells. By blocking this enzyme, pamiparib can prevent cancer cells from repairing themselves, leading to their death. It is classified as a PARP inhibitor, a class of drugs that target cancer cell DNA repair mechanisms.
Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, such as the breast, lung, prostate, or colon. These tumors grow as a result of uncontrolled cell division and can invade nearby tissues. Over time, they may spread to other parts of the body through the bloodstream or lymphatic system. The progression of solid tumors can vary greatly depending on the type and location of the tumor. They are typically classified based on the type of cells they originate from, such as carcinomas or sarcomas.
Hematological malignancies are cancers that begin in the blood-forming tissue, such as the bone marrow, or in the cells of the immune system. These include leukemia, lymphoma, and myeloma, which affect the production and function of blood cells. The disease often leads to the overproduction of abnormal blood cells, which can crowd out normal cells and impair the body's ability to fight infections, carry oxygen, or control bleeding. As the disease progresses, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The progression and symptoms can vary widely depending on the specific type of hematological malignancy. They are often characterized by symptoms such as fatigue, fever, and frequent infections.
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