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NCT03525925 · ClinicalTrials.gov registry record · Phase 1
Ibrutinib and Nivolumab in Treating Participants With Metastatic Solid Tumors
A Phase 1 study, sponsored by Ohio State University Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT03525925: Completed Phase 1 study, sponsored by Ohio State University Comprehensive Cancer Center.
NCT03525925 is a Phase 1 study that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03525925, a Phase 1 study, has completed, sponsored by Ohio State University Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This phase I trial studies how well ibrutinib and nivolumab work in treating participants with solid tumors that have spread to other places in the body. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving ibrutinib and nivolumab may work better in treating participants with solid tumors.
Primary Outcome
Will be summarized using descriptive statistics (N, mean, standard deviation, median, minimum, and maximum) and/or frequency and percentages for medically relevant categories. Changes of the continuous variables will be estimated using mixed model for repeated measures with proper data transformation as needed, and two-way tables and Chi-Square test will be used to summarize the changes of the categorical data.
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Nivolumab
- DRUG Ibrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-07-18 |
| Est. Completion | 2022-07-31 |
| Phase | Phase 1 |
What the finished NCT03525925 record still lists
NCT03525925 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03525925 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03525925 about?
NCT03525925 is a clinical study titled "Ibrutinib and Nivolumab in Treating Participants With Metastatic Solid Tumors". This phase I trial studies how well ibrutinib and nivolumab work in treating participants with solid tumors that have spread to other places in the body. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may...
What is the current status of trial NCT03525925?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2018-07-18. Estimated completion is 2022-07-31.
What interventions are being tested in trial NCT03525925?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Nivolumab (BIOLOGICAL), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT03525925?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03525925's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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