A Phase Ib/II Study of Pembrolizumab, Ibrutinib and Rituximab in Refractory/Relapsed Primary Central Nervous System Lymphoma (PCNSL)
Dana-Farber Cancer Institute
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)
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 de…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must be able to understand and willing to sign a written informed consent document. * Participant must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. * Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study. * Participant must be at least 18 years old on day of signing…
Interventions
- DrugIbrutinib
Capsule, taken by mouth daily
- DrugPembrolizumab
Given as an intravenous injection through a vein (IV) every 3 weeks
- DrugRituximab
Given as infusion into a vein (intravenous, IV)
Locations (4)
- Dana Farber Cancer InstituteBoston, Massachusetts
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Columbia University Medical CenterNew York, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York