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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04380545
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Stage III Hepatocellular Carcinoma AJCC v8
  • Stage IIIA Hepatocellular Carcinoma AJCC v8
  • Stage IIIB Hepatocellular Carcinoma AJCC v8
  • Stage IV Hepatocellular Carcinoma AJCC v8
  • Stage IVA Hepatocellular Carcinoma AJCC v8
  • Stage IVB Hepatocellular Carcinoma AJCC v8
  • Unresectable Fibrolamellar Carcinoma

Eligibility Criteria

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

Interventions

  • Fluorouracil — DRUG
    Given IV
  • Nivolumab — BIOLOGICAL
    Given IV
  • Recombinant Interferon Alpha 2b-like Protein — BIOLOGICAL
    Given SC

Study Details

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.

Key Dates

Start date
Jan 13, 2021
Status verified
Mar 2026
Primary completion
Feb 28, 2028
Completion
Feb 28, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (fluorouracil, interferon alpha 2b, nivolumab)
    Patients receive fluorouracil IV continuously on days 1-7 and 15-21 and recombinant interferon alpha 2b-like protein SC on days 1, 3, 5, 15, 17, and 19. Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Beginning in cycle 3, patients receive nivolumab IV over 30 minutes on day 1, fluorouracil IV continuously on days 1-7 and 15-21, and recombinant interferon alpha 2b-like protein interferon alpha 2b SC on days 1, 3, 5, 15, 17, and 19. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 30 days after last treatment dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Sunyoung Lee
[email protected]
713-792-2828
Sunyoung Lee (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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