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Methotrexate

Nivolumab

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Immune Checkpoint Inhibitors

HD-MTX containing induction chemotherapy (per standard of care) followed by Nivolumab consolidation.

Steven Park, MD

The primary objective of Stage 1 is to evaluate the safety of nivolumab consolidation after completion of HD-MTX containing induction chemotherapy in older subjects with PCNSL in terms of a tolerated dose (based on dose-limiting toxicities) for the expansion phase of the study (Stage 2).The primary objective of Stage 2 is to evaluate the efficacy of nivolumab consolidation after completion of HD-MTX containing induction chemotherapy in terms of the 2-year progression-free survival rate and compare to relevant historical controls

This is a 2-stage phase 1B study of nivolumab consolidation following completion of HD-MTX containing induction chemotherapy in older (≥ 65 years old) patients with previously untreated primary CNS lymphoma. Stage 1 is designed to evaluate the safety of nivolumab consolidation. We plan to use 3+3 design and start at the FDA approved single agent dose of nivolumab 480 mg intravenously every 4 weeks. Stage 2 is designed to evaluate the safety as well as efficacy of nivolumab consolidation after HD-MTX containing induction chemotherapy in an expansion cohort.

Nivolumab Consolidation in Older (≥ 65) Patients With Primary CNS Lymphoma

A Phase 1B Trial Nivolumab Consolidation Following Completion of High-Dose Methotrexate Containing Induction Chemotherapy in Older (≥ 65) Patients With Primary CNS Lymphoma

The primary endpoint for the Stage 1 phase of the study is dose-limiting toxicity which will be assessed for each Stage 1 subject using the DLT criteria

The primary endpoint for the Stage 1 phase of the study is the 2-year progression-free endpoint which will be determined for each subject as a binary variable indicating if they are alive and progression-free at 2 years (PFS2)

PFS is defined as the duration of time from enrollment to first occurrence of either progressive disease or death.

OS is defined as the duration from enrollment to the date of death from any cause.

Objective response will be determined for each subject as a binary variable indicating if they have achieved a best overall response of CR or PR as determined by the International Criteria for PCNSL (IPCG). Complete response will be determined for each subject as a binary variable indicating if they have achieved a best overall response of CR as determined by the International Criteria for PCNSL(IPCG).

Response conversion will be determined for each subject who achieve a best overall response of PR during induction therapy as a binary variable indicating if the subsequently achieve a best overall response of CR to nivolumab consolidation therapy.

Adverse events will be collected for each subject using NCI CTCAE v5.0 criteria. A binary variable will be determined for each subject indicating whether or not the subject experienced an AESI during treatment with nivolumab consolidation therapy, across any cycle nivolumab treatment administration.

A subset analysis of the primary population will be performed on those members of the evaluable population for the primary objective completing at least two cycles of nivolumab. PFS is defined as the duration of time from enrollment to first occurrence of either progressive disease or death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Nivolumab Consolidation in Older (≥ 65) Patients With Primary CNS Lymphoma	NCT04022980	Brain and Nervo... Eye and Orbit	Nivolumab	65 Years -	Wake Forest University Health Sciences
Nivolumab Consolidation in Older (≥ 65) Patients With Primary CNS Lymphoma	NCT04022980	Brain and Nervo... Eye and Orbit	Nivolumab	65 Years -	Wake Forest University Health Sciences

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