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NCT02837029 · ClinicalTrials.gov registry record · Phase 1
Nivolumab and Yttrium Y 90 Glass Microspheres in Treating Patients With Advanced Liver Cancer
A Phase 1 study of Stage IIIA Hepatocellular Carcinoma and Stage IIIB Hepatocellular Carcinoma, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT02837029: Completed Phase 1 study of Stage IIIA Hepatocellular Carcinoma and Stage IIIB Hepatocellular Carcinoma, sponsored by Northwestern University.
NCT02837029 is a Phase 1 study of Stage IIIA Hepatocellular Carcinoma and Stage IIIB Hepatocellular Carcinoma that has completed, run by Northwestern University. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02837029, a Phase 1 study of Stage IIIA Hepatocellular Carcinoma and Stage IIIB Hepatocellular Carcinoma, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to identify maximum tolerated dose (MTD), that is, the highest dose of the study drug nivolumab that does not cause unacceptable side effects, for combination treatment of nivolumab and yttrium Y 90 glass microspheres (Y-90). Also, to evaluate the efficacy (the effect of drug on your tumor) and the tolerability (the effect of the drug on your body) of nivolumab, when given with standard of care Y-90 (Therasphere). Nivolumab is currently Food and Drug Administration (FDA) approved for other cancers, but has not yet been investigated in advanced or refractory hepatocellular carcinoma. Nivolumab is an antibody (a human protein that sticks to a part of the tumor and/or immune cells) designed to allow the body's immune system to work against tumor cells. Y-90 is currently FDA approved for the treatment of hepatocellular carcinomas, but has not yet been investigated in combination with nivolumab for this disease.
Primary Outcome
To identify maximum tolerated dose (MTD) of nivolumab for combination treatment of nivolumab following Y-90 in patients with advanced hepatocellular carcinoma. The MTD will be defined as the highest dose of nivolumab that causes dose limiting toxicities (DLTs) in \<2 of 6 patients. The Phase I portion of the study follows a 3+3 dose escalation design. Nivolumab has two dose levels: Level 1: 80mg IV every 2 weeks, Level 2: 240mg IV every 2 weeks. Toxicity will be assessed using the National Cance
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Nivolumab
- RADIATION Yttrium Y 90 Glass Microspheres
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2016-07 |
| Est. Completion | 2020-11-01 |
| Phase | Phase 1 |
What the finished NCT02837029 record still lists
NCT02837029 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 5 conditions, with Stage IIIA Hepatocellular Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02837029 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT02837029 about?
NCT02837029 is a clinical study titled "Nivolumab and Yttrium Y 90 Glass Microspheres in Treating Patients With Advanced Liver Cancer". The purpose of this study is to identify maximum tolerated dose (MTD), that is, the highest dose of the study drug nivolumab that does not cause unacceptable side effects, for combination treatment of nivolumab and yttrium Y 90 glass microspheres (Y-90). Also, to evaluate the efficacy (the effect of...
What is the current status of trial NCT02837029?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2016-07. Estimated completion is 2020-11-01.
What conditions does trial NCT02837029 study?
This clinical trial studies the following conditions: Stage IIIA Hepatocellular Carcinoma, Stage IIIB Hepatocellular Carcinoma, Stage IIIC Hepatocellular Carcinoma, Stage IVA Hepatocellular Carcinoma, Stage IVB Hepatocellular Carcinoma.
What interventions are being tested in trial NCT02837029?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Nivolumab (BIOLOGICAL), Yttrium Y 90 Glass Microspheres (RADIATION).
Who is sponsoring clinical trial NCT02837029?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02837029 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02837029's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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