A Case Study of Nivolumab for Relapsed/Refractory Primary Central Nervous System Lymphoma

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Nivolumab given intrathecally is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)

Detailed Description
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This is a case study aiming to recruit 1 patient. This study is indicated for relapsed/refractory primary central nervous system lymphoma. Primary objective is to explore the safety.

Official Title
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A Case Study of Nivolumab for Relapsed/Refractory Primary Central Nervous System Lymphoma

Conditions
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Refractory Central Nervous System Lymphoma, Relapsed Primary Central Nervous System Lymphoma, Primary Central Nervous System Lymphoma

Intervention / Treatment
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* Drug: Nivolumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with ECOG 0,1,2,3 Subjects with pathologically confirmed PCNSL with lesion in brain who progressed after or did not respond to at least 1 line of systemic therapy. PCNSL prior therapy may include HD-MTX, HD-MTX-based regimen, high-dose cytarabine, radiation therapy alone as treatment or as part of consolidation therapy, high-dose therapy with autologous stem cell transplant as part of consolidation therapy, and/or intraocular MTX alone or as part of consolidation therapy Subject with sufficient function of liver, kidney, heart, lung and hematopoiesis Subjects with relapsed PCNSL and are able to receive biopsy Exclusion Criteria: Subjects that are not DLBCL type pathologically Intraocular PCNSL without evidence of brain disease Subjects who cannot undergo MRI assessments Relapsed PCNSL patients who cannot undergo biopsy Biopsy suggests no significant tumor-infiltration T cell or poor PD-1 expression Subjects with other malignancy Subjects with history of any inflammatory CNS diseases Subjects with an active, known, or suspected autoimmune disease Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nivolumab administration<br>Nivolumab administration Q2W by intraventricular injection through Ommaya reservoir | Drug: Nivolumab<br>* Nivolumab given intraventricularly<br>* Other names: NIVO；Opdivo; BMS-936558;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Adverse events Adverse events assessed according to NCI-CTCAE v5.0 criteria | On a continuous basis up to 1 month after the first dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best overall response(BOR) | Record individual best overall response(BOR), including CR, PR, SD, PD | up to 3 months after the first dose of study drug |