Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 80 Years|
- - 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.
- - Subject with sufficient function of liver, kidney, heart, lung and hematopoiesis.
- - Subjects with relapsed PCNSL and are able to receive biopsy.
- - 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.
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.
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.
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|
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|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
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|
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.
Experimental: Nivolumab administration
Nivolumab administration Q2W intrathecally by lumbar punctuation
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.