Pembrolizumab, Ibrutinib and Rituximab in PCNSL
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
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)
Eligibility criteria
Qualifiers
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 informed consent.
Disqualifiers
Patients who cannot undergo MRI brain
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40,CD137)
Previously progressed on ibrutinib or other BTK inhibitor use (patient who have previously received BTK inhibitor but not progressed while on it are allowed)
Patients with > Grade 2 intracranial hemorrhage
Trial design
Treatments tested in this trial
- Ibrutinib
- Pembrolizumab
- Rituximab
Treatment groups
37 Participants
are divided into 1 treatment groupSponsors and collaborators
Dana-Farber Cancer Institute
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov