NCT04421560

Pembrolizumab, Ibrutinib and Rituximab in PCNSL

A Phase Ib/II Study of Pembrolizumab, Ibrutinib and Rituximab in Refractory/Relapsed Primary Central Nervous System Lymphoma (PCNSL)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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)

Conditions

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

Interventions

Type	Name	Description
DRUG	Ibrutinib	Capsule, taken by mouth daily
DRUG	Pembrolizumab	Given as an intravenous injection through a vein (IV) every 3 weeks
DRUG	Rituximab	Given as infusion into a vein (intravenous, IV)

Timeline

• Start date: 2020-08-01
• Primary completion: 2026-12-05
• Completion: 2027-01-05
• First posted: 2020-06-09
• Last updated: 2026-02-20

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study