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NCT03025256 · ClinicalTrials.gov registry record · Phase 1
Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease
A Phase 1 study of Metastatic Melanoma and Stage IV Lung Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 71
- Enrollment target
- 1
- Study location
NCT03025256: Active Phase 1 study of Metastatic Melanoma and Stage IV Lung Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT03025256 is a Phase 1 study of Metastatic Melanoma and Stage IV Lung Cancer AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 71 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (14% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03025256, a Phase 1 study of Metastatic Melanoma and Stage IV Lung Cancer AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 71 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/Ib trial studies the side effects and best dose of intrathecal nivolumab, and how well it works in combination with intravenous nivolumab in treating patients with leptomeningeal disease. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
Safety and tolerability of treatment will be assessed by vital signs, laboratory assessments, adverse events, and serious adverse events for the safety population. Adverse events will be graded by the Common Terminology Criteria for Adverse Events version 4.0. Categorical measures will be summarized using frequencies and percentages while continuous variables will be summarized using mean, standard deviation, median, minimum, and maximum.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Lumbar Puncture
- PROCEDURE Magnetic Resonance Imaging
- BIOLOGICAL Nivolumab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2018-05-02 |
| Est. Completion | 2025-12-30 |
| Phase | Phase 1 |
What the registry record for NCT03025256 still lists
NCT03025256 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (14% lower).
The record links to 10 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03025256 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03025256 about?
NCT03025256 is a clinical study titled "Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease". This phase I/Ib trial studies the side effects and best dose of intrathecal nivolumab, and how well it works in combination with intravenous nivolumab in treating patients with leptomeningeal disease. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system atta...
What is the current status of trial NCT03025256?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2018-05-02. Estimated completion is 2025-12-30.
What conditions does trial NCT03025256 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Stage IV Lung Cancer AJCC v8, Metastatic Lung Non-Small Cell Carcinoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Uveal Melanoma.
What interventions are being tested in trial NCT03025256?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Lumbar Puncture (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03025256?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03025256 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03025256's enrollment target sits among peer trials
71 25th of 91 higher than 67 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma 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.
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