Clinical trial · Interventional
A Case Study of Nivolumab for Relapsed/Refractory Primary Central Nervous System Lymphoma
NCT04845139CI-TRIAL-00059536unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Central Nervous System Lymphoma | Primary Central Nervous System Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Refractory Central Nervous System Lymphoma | Central Nervous System Lymphoma | CURATED_BROADER | 0.78 |
| Relapsed Primary Central Nervous System Lymphoma | Primary Central Nervous System Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nivolumab administration
- description
- Nivolumab administration Q2W by intraventricular injection through Ommaya reservoir
- interventionNames
- Drug: Nivolumab
Primary outcomes (1)
- measure
- Adverse events
- timeFrame
- On a continuous basis up to 1 month after the first dose of study drug
- description
- Adverse events Adverse events assessed according to NCI-CTCAE v5.0 criteria
Secondary outcomes (1)
- measure
- Best overall response(BOR)
- timeFrame
- up to 3 months after the first dose of study drug
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.