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

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Primary Central Nervous System Lymphoma; Refractory Central Nervous System Lymphoma; Relapsed Primary Central Nervous System Lymphoma
• Intervention / Treatment: Drug: Nivolumab

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Jianmin Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nivolumab administration; Nivolumab administration Q2W by intraventricular injection through Ommaya reservoir	Drug: Nivolumab; Nivolumab given intraventricularly; Other Names: NIVO；Opdivo; BMS-936558

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best overall response(BOR)	Record individual best overall response(BOR), including CR, PR, SD, PD	up to 3 months after the first dose of study drug

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): July 2, 2022
• Primary Completion (Anticipated): October 30, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: April 11, 2021
• First Submitted That Met QC Criteria: April 11, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 3, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: 2021-0139 (Other Grant/Funding Number: Sygeforsikring Danmark)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No