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

Not Applicable

• Conditions: Refractory Central Nervous System Lymphoma; Primary Central Nervous System Lymphoma; Relapsed Primary Central Nervous System Lymphoma
• Interventions: Drug: Nivolumab

• Registration Number: NCT04845139
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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)

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 Timeline

• Study First Submitted: 2021-04-11
• Study First Submitted QC: 2021-04-11
• Study First Posted: 2021-04-14
• Status Verified: 2022-07
• Study Start: 2022-07-02
• Last Update Submitted: 2022-07-03
• Last Update Posted: 2022-07-07
• Primary Completion: 2022-10-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nivolumab administration	Nivolumab	Nivolumab administration Q2W by intraventricular injection through Ommaya reservoir

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Jianmin Zhang; 🇨🇳 Hangzhou, Zhejiang, China