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NCT04022980 · ClinicalTrials.gov registry record · Phase 1
Nivolumab Consolidation in Older (≥ 65) Patients With Primary CNS Lymphoma
A Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT04022980: Completed Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT04022980 is a Phase 1 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04022980, a Phase 1 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study 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
Primary Outcome
The primary endpoint for the Stage 1 phase of the study is dose-limiting toxicity which will be assessed for each Stage 1 subject using the DLT criteria
Interventions
- DRUG Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-03-31 |
| Est. Completion | 2025-12-22 |
| Phase | Phase 1 |
What the finished NCT04022980 record still lists
NCT04022980 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Nivolumab is the first listed.
NCT04022980 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04022980 about?
NCT04022980 is a clinical study titled "Nivolumab Consolidation in Older (≥ 65) Patients With Primary CNS Lymphoma". 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 ...
What is the current status of trial NCT04022980?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2020-03-31. Estimated completion is 2025-12-22.
What interventions are being tested in trial NCT04022980?
The interventions under investigation include: Nivolumab (DRUG).
Who is sponsoring clinical trial NCT04022980?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04022980's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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