Primary Central Nervous System Lymphoma Clinical Trial
Official title:
A Phase Ib/II Study of Pembrolizumab, Ibrutinib and Rituximab in Refractory/Relapsed Primary Central Nervous System Lymphoma (PCNSL)
This research study is evaluating a combination therapy of 3 drugs as possible treatments for recurrent primary central nervous system lymphoma (PCNSL). The three drugs being used in the study are: - Pembrolizumab (MK3475) - Ibrutinib - Rituximab (or biosimilar)
This is an open label, multi-center, phase Ib/II trial of Pembrolizumab, Ibrutinib and Rituximab in participants with refractory/relapsed Primary Central Nervous System Lymphoma. - A Phase I clinical trial tests the safety of an investigational intervention and also tries to define the appropriate dose(s) of the investigational intervention to use for further studies. - Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. The dose of investigational intervention in Phase II will depend on the results from Phase Ib - "Investigational" means that the intervention is being studied. - The FDA (the U.S. Food and Drug Administration) has not approved Pembrolizumab, ibrutinib or rituximab for refractory/relapsed primary central nervous system lymphoma (PCNSL) but these have been approved for other uses including other types of non-Hodgkin's lymphoma. - Pembrolizumab (MK-3475) has been studied in lab experiments and in other types of cancer, and information from these studies suggests that Pembrolizumab may be beneficial in this type of cancer. Pembrolizumab is a humanized monoclonal antibody. An antibody is a common type of protein made in the body in response to a foreign substance. Antibodies attack foreign substances and protect against infection. Antibodies can also be produced in the laboratory for use in treating patients; an antibody that is made in the lab is also known as humanized monoclonal antibody that is designed to block the action of the receptor, PD-1. PD-1 works to help tumor cells continue to grow and multiply. There are now several approved antibodies for the therapy of cancer and other diseases. - Ibrutinib is a type of drug called a kinase inhibitor. It is believed to block a type of protein called a kinase that helps lymphoma cells live and grow. By blocking this, it is possible that the study drug will kill cancer cells or stop them from growing. - Rituximab is a type of drug called a monoclonal antibody. An antibody is a common type of protein made in the body in response to a foreign substance. Antibodies attack foreign substances and protect against infection. Rituximab works with the immune system and has shown evidence for clinical activity when administered in combinations to treat lymphoma. - The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. - The three drugs being used in the study are: - Pembrolizumab (MK3475) - Ibrutinib - Rituximab (or biosimilar) - Participants will receive study treatment for up to 2 years as long as they do not have serious side effects and their disease does not get worse. Once off study, participants will be followed every 3 months for the rest of their life. - Phase I Enrollment: Approximately 9 to 12 participants - Phase II Enrollment :Approximately 25 patients Merck & Co., Inc, a pharmaceutical company, is supporting this research study by providing funding for the research study and the study drug, Pembrolizumab (MK-3475) ;
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