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NCT03439891 · ClinicalTrials.gov registry record · Phase 2

Sorafenib and Nivolumab in Treating Participants With Unresectable, Locally Advanced or Metastatic Liver Cancer

A Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, sponsored by Robin Kate Kelley.

Completed
Registry status
Phase 2
Development phase
16
Enrollment target
2
Study locations

NCT03439891 is a Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8 that has completed, run by Robin Kate Kelley. The registered enrollment target is 16 participants, below the 59-participant average among 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials with a reported enrollment target (73% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT03439891, a Phase 2 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, has completed, sponsored by Robin Kate Kelley.

COMPLETED
Registry status
Phase 2
Development phase
16 participants
Enrollment target
2
Study locations

Study Summary

This phase II trial studies the best dose and side effects of sorafenib tosylate and nivolumab in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to nearby tissues or lymph nodes (locally advanced) or to other places in the body (metastatic). Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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. Giving sorafenib tosylate and nivolumab may work better in treating patients with liver cancer.

Conditions Studied

Stage III Hepatocellular Carcinoma AJCC v8 Stage IV Hepatocellular Carcinoma AJCC v8 Stage IIIA Hepatocellular Carcinoma AJCC V8 Stage IVA Hepatocellular Carcinoma AJCC V8 Stage IVB Hepatocellular Carcinoma AJCC V8 Stage IIIB Hepatocellular Carcinoma AJCC v7 Stage IIIC Hepatocellular Carcinoma AJCC v7

Interventions

  • BIOLOGICAL Nivolumab
  • DRUG Sorafenib

Study Locations (2)

California

  • University of California, Davis - Sacramento
  • University of California, San Francisco - San Francisco

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2018-04-16
Est. Completion 2023-11-30
Phase Phase 2

Sponsor

Robin Kate Kelley

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03439891

The ClinicalTrials.gov registry entry for NCT03439891 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 59-participant average among 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials with a reported enrollment target (73% lower). The listed sponsor is Robin Kate Kelley, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 7 conditions, with Stage III Hepatocellular Carcinoma AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.

NCT03439891 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT03439891 about?

NCT03439891 is a clinical study titled "Sorafenib and Nivolumab in Treating Participants With Unresectable, Locally Advanced or Metastatic Liver Cancer". This phase II trial studies the best dose and side effects of sorafenib tosylate and nivolumab in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to nearby tissues or lymph nodes (locally advanced) or to other places in the body (metastatic). Sorafeni...

What is the current status of trial NCT03439891?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2018-04-16. Estimated completion is 2023-11-30.

What conditions does trial NCT03439891 study?

This clinical trial studies the following conditions: Stage III Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC V8, Stage IVA Hepatocellular Carcinoma AJCC V8, Stage IVB Hepatocellular Carcinoma AJCC V8.

What interventions are being tested in trial NCT03439891?

The interventions under investigation include: Nivolumab (BIOLOGICAL), Sorafenib (DRUG).

Who is sponsoring clinical trial NCT03439891?

This trial is sponsored by Robin Kate Kelley, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03439891 being conducted?

This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.