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

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04845139
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Second Affiliated Hospital, School of Medicine, Zhejiang University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jianmin Zhang, M.D.
Principal Investigator Affiliation Second Affiliated Hospital, School of Medicine, Zhejiang University, China
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

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.

Arms & Interventions

Arms

Experimental: Nivolumab administration

Nivolumab administration Q2W intrathecally by lumbar punctuation

Interventions

Drug: - Nivolumab

Nivolumab given intrathecally

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Jianmin Zhang, Hangzhou, Zhejiang, China

Status

Recruiting

Address

Jianmin Zhang

Hangzhou, Zhejiang, 310000

Site Contact

Jianmin Zhang, M.D., Ph.D.

zjm135@zju.edu.cn

+86 0571 87784755.

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