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Alkylating agents

IRX-2 + Cyclophosphamide + Nivolumab for Liver Cancer

Phase 1

Waitlist Available

Led By Daneng Li

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with recurrent or metastatic HCC that are not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy)

Up to three prior systemic therapy regimens for recurrent and/or metastatic disease

Must not have

Prior exposure to PD-1/PD-L1 inhibitors

Prior exposure to IRX-2 regimen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trialstudies a combo of drugs to treat liver cancer that has come back or spread. It may help the immune system attack the cancer and stop tumor cells from growing.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include immune system reactions leading to inflammation in various organs, infusion-related reactions from the drug administration process, fatigue, digestive issues like nausea or diarrhea, changes in blood cell counts which can affect infection risk and healing capacity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am fully active or can carry out light work.

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

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My liver cancer has returned or spread.

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I have at least one tumor that can be measured.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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

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

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

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I have or had an autoimmune or inflammatory disorder.

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

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I have received an organ transplant from another person.

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I have serious heart or lung conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Recommended phase II dose

Secondary study objectives

Median progression-free survival (PFS)

Overall response rate

PFS

Other study objectives

Circulating immune cell profiles circulating tumor deoxyribonucleic acid (DNA)

Tumor neoantigen

Side effects data

From 2023 Phase 1 & 2 trial • 9 Patients • NCT03918499

100%

Anemia

78%

Hypoalbuminemia

78%

Nausea

78%

Fatigue

78%

Alkaline phosphatase increased

78%

Peripheral sensory neuropathy

67%

Anorexia

67%

Hypocalcemia

67%

Hyponatremia

56%

Abdominal pain

56%

Constipation

56%

Dysphagia

56%

10020772-Hypertension

44%

Dyspnea

44%

Hypoproteinemia

44%

Diarrhea

44%

Vomiting

44%

Cough

33%

Pain in extremity

33%

Hyperglycemia

33%

Pain

33%

Thyroid stimulating hormone inc

33%

Edema limbs

33%

Hypokalemia

22%

Hyperchloremia

22%

Hypochlorinemia

22%

Hiccups

22%

Nasal congestion

22%

Pleural effusion

22%

Dry skin

22%

Pruritus

22%

Fever

22%

Sinus tachycardia

22%

Ascites

22%

Gastroesophageal reflux disease

22%

Alanine aminotransferase increa

22%

Aspartate aminotransferase incr

22%

Platelet count decreased

11%

Excessive Sweating

11%

Night Sweats

11%

Atrial fibrillation

11%

Pericardial effusion

11%

Pulmonary valve disease

11%

Aortic valve disease

11%

Abnormal QRS-T angle, consider primary T

11%

Non-specific T Wave Abnormality

11%

Ear pain

11%

Flu like symptoms

11%

White blood cell decreased

11%

Hypochloremia

11%

Hypoprotenemia

11%

Platet Count Increased

11%

Hyperphosphatemia

11%

Muscle cramp

11%

Neck pain

11%

Muscle weakness upper limb

11%

Left Arm Weakness

11%

Productive cough

11%

Sore throat

11%

Sinus disorder

11%

Chest Congestion

11%

Chest congestion

11%

Rash acneiform

11%

Rash maculo-papular

11%

Dermatitis

11%

Palpitations

11%

ST and T Wave Abnormality

11%

Glaucoma

11%

Double Vision

11%

Double vision

11%

Retinal Hemorrhage

11%

Swelling around the eye

11%

Dehydration

11%

Sinus bradycardia

11%

10005886-Blurred vision

11%

Endocarditis infective

11%

Wheezing

11%

Tricuspid valve disease

11%

Mitral valve disease

11%

Sinus Bradycardia

11%

T Wave Abnormality

11%

Non-cardiac chest pain

11%

Left Lower Extremity Edema

11%

Sepsis

11%

Platelet Count Increased

11%

Hypoglycemia

11%

Tachycardia

11%

Small intestinal obstruction

11%

Pneumothorax

11%

Abdominal distension

11%

Bloating

11%

Acid Reflux

11%

Early Satiety

11%

Teeth Sensitivity

11%

Chills

11%

Bruising

11%

Activated partial thromboplasti

11%

Blood bilirubin increased

11%

Lymphocyte count decreased

11%

Dysgeusia

11%

Headache

11%

Insomnia

11%

Proteinuria

11%

Urinary retention

11%

Skin Rash-Waist

11%

Skin rash-Waist

11%

Vitiligo

11%

Bleeding at right injection site

11%

Soreness at injection site

11%

10021097-Hypotension

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Pembrolizumab, Cyclophosphamide, and IRX-2)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~5220

Cyclophosphamide

2010

Completed Phase 4

~2310