IRX-2 + Cyclophosphamide + Nivolumab for Liver Cancer

Palo Alto (17 mi)

Overseen byDaneng Li

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with advanced liver cancer that has returned or spread and isn't responding to treatment. Participants must have certain blood counts, weigh over 30 Kg, have a specific liver function score (Child-Pugh class A), and be able to give informed consent. They should not have had more than three prior treatments for their condition and must not be pregnant or breastfeeding.

Inclusion Criteria

My liver cancer cannot be treated with surgery or radiation aimed at a cure.

I have had up to three treatments for my cancer that has returned or spread.

I am fully active or can carry out light work.

My kidney function, measured by creatinine clearance, is above 40 mL/min.

My liver cancer has returned or spread.

I have at least one tumor that can be measured.

I have tried at least one treatment for advanced liver cancer that didn't work or I couldn't tolerate.

Exclusion Criteria

I have been treated with PD-1/PD-L1 inhibitors before.

I have been treated with the IRX-2 regimen before.

I have had a heart attack in the last 3 months.

I have had cancer spread to the lining of my brain and spinal cord.

I have had cancer before and am not currently free of the disease.

I am showing signs of an infection that affects my whole body.

I have or had an autoimmune or inflammatory disorder.

I have active Hepatitis B that hasn't been treated.

I have received an organ transplant from another person.

I have serious heart or lung conditions.

Treatment Details

The study is testing the combination of IRX-2 (a biological therapy), cyclophosphamide (chemotherapy), and nivolumab (an immunotherapy) to see if this trio is more effective than previous treatments for hepatocellular carcinoma. The trial will determine the best dose of IRX-2 when used with the other drugs.

1Treatment groups

Experimental Treatment

Group I: Treatment (nivolumab, cyclophosphamide, IRX-2)Experimental Treatment3 Interventions

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.

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Cytoxan for: