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NCT04401774 · ClinicalTrials.gov registry record · Phase 2
Nivolumab Maintenance in Newly Diagnosed PCNSL With Persistent CSF Circulating Tumor DNA After Completion of First-Line Chemotherapy
A Phase 2 study of Primary Central Nervous System Lymphoma (PCNSL), sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 7
- Study locations
NCT04401774: Completed Phase 2 study of Primary Central Nervous System Lymphoma (PCNSL), sponsored by Memorial Sloan Kettering Cancer Center.
NCT04401774 is a Phase 2 study of Primary Central Nervous System Lymphoma (PCNSL) that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 14 participants, below the 181-participant average among 5 other Primary Central Nervous System Lymphoma (PCNSL) trials with a reported enrollment target (92% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04401774, a Phase 2 study of Primary Central Nervous System Lymphoma (PCNSL), has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this additional part of the study is to test whether the study drug, nivolumab, is a safe treatment that will prevent participants' primary central nervous system lymphoma (PCNSL) from growing again (recurrence). Participants will be people with PCNSL who continue to have cell free tumor DNA (cfDNA) in their CSF despite completion of their first treatment (first-line treatment).
Primary Outcome
Frequencies of toxicities will be summarized based on the Common Toxicity Criteria (CTCAE) version 5.0. Adverse events.
Conditions Studied
Interventions
- DRUG Nivolumab
Study Locations (7)
New York
- Memorial Sloan Kettering Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
- Memorial Sloan Kettering Nassau (Limited protocol activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-05-22 |
| Est. Completion | 2026-01-22 |
| Phase | Phase 2 |
What the finished NCT04401774 record still lists
NCT04401774 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 181-participant average among 5 other Primary Central Nervous System Lymphoma (PCNSL) trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Primary Central Nervous System Lymphoma (PCNSL) appearing as the primary indexed condition, and to 1 intervention - of which Nivolumab is the first listed.
NCT04401774 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT04401774 about?
NCT04401774 is a clinical study titled "Nivolumab Maintenance in Newly Diagnosed PCNSL With Persistent CSF Circulating Tumor DNA After Completion of First-Line Chemotherapy". The purpose of this additional part of the study is to test whether the study drug, nivolumab, is a safe treatment that will prevent participants' primary central nervous system lymphoma (PCNSL) from growing again (recurrence). Participants will be people with PCNSL who continue to have cell free tu...
What is the current status of trial NCT04401774?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2020-05-22. Estimated completion is 2026-01-22.
What conditions does trial NCT04401774 study?
This clinical trial studies the following conditions: Primary Central Nervous System Lymphoma (PCNSL).
What interventions are being tested in trial NCT04401774?
The interventions under investigation include: Nivolumab (DRUG).
Who is sponsoring clinical trial NCT04401774?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04401774 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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