Pembrolizumab, Ibrutinib and Rituximab in PCNSL

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)

Status Recruiting

Clinical Trial Summary

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)

Clinical Trial Description

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) ;

Related Conditions & MeSH terms

• Lymphoma
• Primary Central Nervous System Lymphoma
• Recurrence
• Recurrent Cancer
• Refractory Cancer
• Relapsed Cancer

• NCT number: NCT04421560
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Contact: Lakshmi Nayak, MD
• Phone: (617) 632-2166
• Email: lnayak2@partners.org
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 1, 2020
• Completion date: March 5, 2025