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

Primary Purpose

Refractory Central Nervous System Lymphoma, Relapsed Primary Central Nervous System Lymphoma, Primary Central Nervous System Lymphoma

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nivolumab
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Central Nervous System Lymphoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jianmin Zhang

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nivolumab administration

Arm Description

Nivolumab administration Q2W by intraventricular injection through Ommaya reservoir

Outcomes

Primary Outcome Measures

Adverse events
Adverse events Adverse events assessed according to NCI-CTCAE v5.0 criteria

Secondary Outcome Measures

Best overall response(BOR)
Record individual best overall response(BOR), including CR, PR, SD, PD

Full Information

First Posted
April 11, 2021
Last Updated
July 3, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04845139
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Central Nervous System Lymphoma, Relapsed Primary Central Nervous System Lymphoma, Primary Central Nervous System Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab administration
Arm Type
Experimental
Arm Description
Nivolumab administration Q2W by intraventricular injection through Ommaya reservoir
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
NIVO；Opdivo; BMS-936558
Intervention Description
Nivolumab given intraventricularly
Primary Outcome Measure Information:
Title
Adverse events
Description
Adverse events Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time Frame
On a continuous basis up to 1 month after the first dose of study drug
Secondary Outcome Measure Information:
Title
Best overall response(BOR)
Description
Record individual best overall response(BOR), including CR, PR, SD, PD
Time Frame
up to 3 months after the first dose of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianmin Zhang, M.D.
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jianmin Zhang
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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