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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04845139
Collaborator
(none)
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Study Details

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Case Study of Nivolumab for Relapsed/Refractory Primary Central Nervous System Lymphoma
Actual Study Start Date :
Jul 2, 2022
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Adverse events [On a continuous basis up to 1 month after the first dose of study drug]

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

    Secondary Outcome Measures

    1. Best overall response(BOR) [up to 3 months after the first dose of study drug]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jianmin Zhang Hangzhou Zhejiang China 310000

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT04845139
    Other Study ID Numbers:
    • 2021-0139
    First Posted:
    Apr 14, 2021
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 7, 2022