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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Pembrolizumab
DrugHumanized immunoglobin G4 monoclonal antibody, 4 mL vials, via intravenous infusion (into the vein) per protocol.
Methotrexate
DrugAnti-metabolite, 50 mL vials, via intravenous infusion per protocol.
Temozolomide
DrugAlkylating agent, 5, 20, 100, 140, 180, or 250 mg capsules, taken orally per protocol.
Rituximab
DrugAnti-CD20 antibody, 10 or 50 mL single-use vials, via intravenous infusion per standard of care.
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: Induction Treatment:Experimental treatment 4 interventions
Group B: Consolidation Treatment:Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Patients Experienced Dose Limiting Toxicity (DLT)
Dose-limiting toxicities (DLTs) will be defined as any grade ≥3 non-hematologic toxicity (with exceptions), grade 4 neutropenia lasting \>7 days or febrile neutropenia, grade 4 thrombocytopenia, grade 3 thrombocytopenia with clinically significant bleeding, any grade 5 toxicity or dose delays for \>14 consecutive days (related to AEs) with exceptions. Toxicities are to be assess according to the CTCAE v5.
Time frame
Up to 28 daysSecondary outcomes
1
Complete Response Rate (CRR)
CRR is defined as the proportion of participants who achieved complete response (CR). Radiographic response will be assessed using IPCG criteria.
Time frame
Up to 16 weeks2
Objective Response Rate (ORR)
Objective response rate (ORR), defined as best overall response of either complete or partial response, will be assessed among participants who start protocol therapy and have measurable disease at screening. Radiographic response will be assessed using IPCG criteria.
Time frame
Up to 106 weeks3
2-Year Progression Free Survival (PFS2)
PFS2 is the percent probability estimate at 2 years based on the Kaplan-Meier method. PFS is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD were censored at the earliest of the date of the last disease evaluation or start of new anticancer therapy.
Time frame
Up to 2 years4
Duration of Response (DOR)
DOR is defined as the time from date of first documented confirmed objective response to date of first documented progressive disease (PD).
Time frame
Up to 106 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dana-Farber Cancer Institute
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov