Clinical trial NCT04845139: A Case Study of Nivolumab for Relapsed/Refractory Primary Central Nervous System Lymphoma
Official title: A Case Study of Nivolumab for Relapsed/Refractory Primary Central Nervous System Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Refractory Central Nervous System Lymphoma
Relapsed Primary Central Nervous System Lymphoma
Primary Central Nervous System Lymphoma
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Adverse events
timeFrame: On a continuous basis up to 1 month after the first dose of study drug
Secondary outcomes:
measure: Best overall response(BOR)
timeFrame: up to 3 months after the first dose of study drug
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Jianmin Zhang
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Jianmin Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: