A Case Study of Nivolumab for Relapsed/Refractory Primary Central Nervous System Lymphoma
Study Details
Study Description
Brief Summary
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)
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Nivolumab administration Nivolumab administration Q2W by intraventricular injection through Ommaya reservoir |
Drug: Nivolumab
Nivolumab given intraventricularly
Other Names:
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Outcome Measures
Primary Outcome Measures
- Adverse events [On a continuous basis up to 1 month after the first dose of study drug]
Adverse events Adverse events assessed according to NCI-CTCAE v5.0 criteria
Secondary Outcome Measures
- Best overall response(BOR) [up to 3 months after the first dose of study drug]
Record individual best overall response(BOR), including CR, PR, SD, PD
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects with ECOG 0,1,2,3
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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
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Subject with sufficient function of liver, kidney, heart, lung and hematopoiesis
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Subjects with relapsed PCNSL and are able to receive biopsy
Exclusion Criteria:
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Subjects that are not DLBCL type pathologically
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Intraocular PCNSL without evidence of brain disease
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Subjects who cannot undergo MRI assessments
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Relapsed PCNSL patients who cannot undergo biopsy
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Biopsy suggests no significant tumor-infiltration T cell or poor PD-1 expression
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Subjects with other malignancy
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Subjects with history of any inflammatory CNS diseases
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Subjects with an active, known, or suspected autoimmune disease
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Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Jianmin Zhang | Hangzhou | Zhejiang | China | 310000 |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
- Principal Investigator: Jianmin Zhang, M.D., Second Affiliated Hospital, School of Medicine, Zhejiang University, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-0139