drugset / Trial / NCT04022980
Nivolumab Consolidation in Older (≥ 65) Patients With Primary CNS Lymphoma
Phase 1
Completed
14 enrolled
Wake Forest University Health Sciences
Atrium Health Levine Cancer Institute · collabBristol-Myers Squibb · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
The primary objective of Stage 1 is to evaluate the safety of nivolumab consolidation after completion of HD-MTX containing induction chemotherapy in older subjects with PCNSL in terms of a tolerated dose (based on dose-limiting toxicities) for the expansion phase of the study (Stage 2).The primary objective of Stage 2 is to evaluate the efficacy of nivolumab consolidation after completion of HD-MTX containing induction chemotherapy in terms of the 2-year progression-free survival rate and compare to relevant historical controls
Timeline
- Start
- 2020-03-31
- Primary completion
- 2025-01-21
- Completion
- 2025-12-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |