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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 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. The trial reports 1 study location across 1 state.

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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.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • BIOLOGICAL Nivolumab
  • RADIATION Yttrium Y 90 Glass Microspheres

Study Locations (1)

Illinois

  • Northwestern University - Chicago

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2016-07
Est. Completion 2020-11-01
Phase Phase 1

Sponsor

Northwestern University

1,209 total trials

What the Registry Record Tells You About NCT02837029

The ClinicalTrials.gov registry entry for NCT02837029 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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