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

NCT ID: NCT04845139

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-02
• Study Completion Date: 2022-11-30

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.

Conditions

Refractory Central Nervous System Lymphoma; Relapsed Primary Central Nervous System Lymphoma; Primary Central Nervous System Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nivolumab administration

Nivolumab administration Q2W by intraventricular injection through Ommaya reservoir

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: DRUG

Nivolumab given intraventricularly

Interventions

Nivolumab

Nivolumab given intraventricularly

Intervention Type: DRUG

Other Intervention Names

NIVO；Opdivo; BMS-936558

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianmin Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University, China

Locations

Jianmin Zhang

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2021-0139

Identifier Type: -

Identifier Source: org_study_id