RecruitingPhase 1Phase 2NCT04380545

Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer

A Phase I/II Study of Nivolumab Plus 5-Fluorouracil Plus Interferon-α2b for Unresectable Fibrolamellar Hepatocellular Carcinoma


Sponsor

M.D. Anderson Cancer Center

Enrollment

15 participants

Start Date

Jan 13, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I/II trial studies the side effects and how well nivolumab, fluorouracil, and interferon alpha 2b work for the treatment of fibrolamellar cancer (liver cell cancer) that cannot be removed by surgery (unresectable). 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. Chemotherapy drugs, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Interferon alpha 2b may help stimulate the immune system to fight cancer. Giving nivolumab, fluorouracil, and interferon alpha 2b may work better in treating unresectable fibrolamellar cancer compared to fluorouracil and interferon alpha 2b alone.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of three drugs — nivolumab (immunotherapy), fluorouracil (chemotherapy), and interferon alpha 2B — for people with fibrolamellar hepatocellular carcinoma (FLHCC), a rare liver cancer that mainly affects young people without cirrhosis and for which few treatments exist. **You may be eligible if...** - You have a confirmed diagnosis of FLHCC (either by biopsy or prior documentation) - Your cancer cannot be surgically removed - You have measurable disease on imaging - Your overall health is good (ECOG 0-1, or Karnofsky 70+ for those under 18) - Your liver function, blood counts, and kidney function are within acceptable ranges - You have not previously received anti-PD-1 immunotherapy for FLHCC **You may NOT be eligible if...** - You have HIV, active hepatitis B, or active hepatitis C - You have had a liver transplant - You have a history of autoimmune disease (e.g., lupus, rheumatoid arthritis, Crohn's disease) - You have brain metastases or seizure disorders - You have had a heart attack, unstable chest pain, or significant heart disease in the last year - You are pregnant or breastfeeding - You are on anticoagulation therapy (blood thinners), high-dose steroids, or immune-suppressing drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFluorouracil

Given IV

BIOLOGICALNivolumab

Given IV

BIOLOGICALRecombinant Interferon Alpha 2b-like Protein

Given SC


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04380545


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