IRX-2, Cyclophosphamide, and Nivolumab in Treating Patients With Recurrent or Metastatic and Refractory Liver Cancer

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
City of Hope Medical Center
Study ID
NCT03655002
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Recurrent Hepatocellular Carcinoma
  • Refractory Liver Carcinoma
  • 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

  • Cyclophosphamide — DRUG
    Given IV
  • Cytokine-based Biologic Agent IRX-2 — BIOLOGICAL
    Given SC
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

This phase Ib trial studies the side effects and best dose of IRX-2 when given together with cyclophosphamide and nivolumab in treating patients with liver cancer that has come back or spread to other parts of the body and does not response to treatment. Biological therapies, such as IRX-2, may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, 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. 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 IRX-2, cyclophosphamide, and nivolumab may work better than the IRX?2 regimen alone in treating patients with hepatocellular carcinoma.

Key Dates

Start date
Feb 21, 2019
Status verified
Apr 2026
Primary completion
Mar 2, 2027
Completion
Mar 2, 2027

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nivolumab, cyclophosphamide, IRX-2)
    Patients receive nivolumab IV over 30 minutes on day 1, cyclophosphamide IV on day 1, and IRX-2 SC for 10 days between days 4 and 15. Cycles repeat every 28 days for up to 18 months in the absence of disease progression or unacceptable toxicity. Patients receive booster IRX-2 SC at 3, 6, 9, 12, and 15 months.

Primary Outcome Measure

Recommended phase II dose [ Time Frame: Up to 28 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
HonorHealth Research InstituteScottsdaleArizona85258-
City of Hope Medical CenterDuarteCalifornia91010-
Texas Oncology at Baylor Charles A Sammons Cancer CenterDallasTexas75246-

Find similar trials in Scottsdale, AZ

By research site
HonorHealth Research Institute· Scottsdale, AZCity of Hope Medical Center· Duarte, CATexas Oncology at Baylor Charles A Sammons Cancer Center· Dallas, TX

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