Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSL
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
This research study is studying if the investigational drug, Pembrolizumab, in combination with chemotherapy helps primary central nervous system lymphoma with acceptable side effects.
This research study involves a combination of the below drugs:
* Pembrolizumab (a type of monoclonal antibody) * Methotrexate (a type of anti-metabolite) * Temozolomide (a type of alkylating agent) * Rituximab (a type of antibody)
Eligibility criteria
Qualifiers
Brain biopsy or resection
Cerebrospinal fluid
Vitreous fluid
Participants must not have any evidence or history of DLBCL outside of the CNS. Participants with prior history of isolated intraocular lymphoma (primary vitreoretinal lymphoma/PVRL) who have received only local therapy are allowed.
Disqualifiers
Participants who cannot undergo MRI
Intraocular PCNSL without evidence of brain or spinal cord disease.
Participants who are receiving any other investigational agents.
History of allergic reactions or severe hypersensitivity reactions (≥grade 3) attributed to compounds of similar chemical or biologic composition to study agent and/or any of its excipients.
Trial design
Treatments tested in this trial
- Pembrolizumab
- Methotrexate
- Temozolomide
- Rituximab
Treatment groups
15 Participants
are divided into 2 treatment groupsSponsors and collaborators
Dana-Farber Cancer Institute
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov