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

NCT04845139 | Unknown

• 1 other identifier: 2021-0139
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Best overall response(BOR)

  up to 3 months after the first dose of study drug

Study Arms (1)

Nivolumab administration

EXPERIMENTAL

Nivolumab administration Q2W by intraventricular injection through Ommaya reservoir

Drug: Nivolumab

Interventions

Nivolumab DRUG

Nivolumab given intraventricularly

Also known as: NIVO；Opdivo; BMS-936558

Nivolumab administration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Jianmin Zhang

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jianmin Zhang, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 14, 2021
• Study Start: July 2, 2022
• Primary Completion: October 30, 2022
• Study Completion: November 30, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)