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

Part of paid clinical trials in Sacramento, California.

Sponsor
Robin Kate Kelley
Study ID
NCT03439891
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — BIOLOGICAL
    Given IV
  • Sorafenib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Apr 16, 2018
Status verified
Jan 2025
Primary completion
Nov 30, 2023
Completion
Nov 30, 2023

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Starting Dose Schedule (DL -1) Once a day
    Participants with Child-Pugh A or B7 receive a daily dose of 400mg sorafenib on days 1-28, and 240mg of nivolumab IV over 30 minutes beginning on day 15 of course 1, then on days 1 and 15 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Course will continue until 1 dose-limiting toxicity occurs to establish maximum tolerated dosing schedule.
  • Experimental: Part 1: Escalated Dose Schedule (DL 1) Twice a day
    Participants with Child-Pugh A or B7 receive a daily dose of 400mg sorafenib twice a day on days 1-28, and 240mg of nivolumab IV over 30 minutes beginning on day 15 of course 1, then on days 1 and 15 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Course will continue until 1 dose-limiting toxicity occurs to establish maximum tolerated dosing schedule.
  • Experimental: Part 2: Child-Pugh B (CPB) Expansion Cohort (sorafenib, nivolumab)
    Participants with Child-Pugh B7-9 receive sorafenib at the maximum tolerated dose (MTD) established in Part 1 on days 1-28, and nivolumab IV over 30 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) (Part 1 Only) [ Time Frame: 28 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, DavisSacramentoCalifornia95817-
University of California, San FranciscoSan FranciscoCalifornia94143-

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