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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Recommended phase II dose

Secondary outcome measures

Median progression-free survival (PFS)

Overall response rate

Overall survival

+1 more

Other outcome measures

Circulating immune cell profiles circulating tumor deoxyribonucleic acid (DNA)

Circulation T cell profiles

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)

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

Cyclophosphamide

1995

Completed Phase 3

~3770

Cytokine-based Biologic Agent IRX-2

2019

Completed Phase 2

~10

Nivolumab

2014

Completed Phase 3

~4750

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,481 Total Patients Enrolled

44 Trials studying Hepatocellular Carcinoma

6,310 Patients Enrolled for Hepatocellular Carcinoma

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,452 Total Patients Enrolled

2 Trials studying Hepatocellular Carcinoma

411 Patients Enrolled for Hepatocellular Carcinoma

Daneng LiPrincipal InvestigatorCity of Hope Medical Center

2 Previous Clinical Trials

632 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03655002 — Phase 1

Hepatocellular Carcinoma Research Study Groups: Treatment (nivolumab, cyclophosphamide, IRX-2)

Hepatocellular Carcinoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT03655002 — Phase 1

Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03655002 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for participant enrollment in this medical trial?

"This research is not currently seeking enrolment. It was posted on February 21st, 2019 and last updated on October 7th 2022. For those looking for other clinical trials to participate in, there are 2597 studies recruiting patients that have been diagnosed with carcinoma hepatocellular and 1511 accepting participants of the Cytokine-based Biologic Agent IRX-2 trial."

Answered by AI

To what sorts of medical issues is Cytokine-based Biologic Agent IRX-2 usually recommended?

"IRX-2, a cytokine-based biologic agent, has been proven to posses efficacy in the treatment of multiple sclerosis, acute leukemia, myelocytic neoplasms and malignant tumours."

Answered by AI

Has the Food and Drug Administration given its stamp of approval to Cytokine-based Biologic Agent IRX-2?

"Due to the preliminary nature of this clinical trial, our team at Power assigned IRX-2 a safety rating of 1. This is because Phase 1 trials typically provide only limited data concerning efficacy and safety."

Answered by AI

Could you provide further information on the research preceding Cytokine-based Biologic Agent IRX-2?

"Currently, there are 1,511 live research trials assessing the efficacy of Cytokine-based Biologic Agent IRX-2 with 234 studies in Phase 3. Furthermore, 67197 locations worldwide are running investigations into this biologic agent; Philadelphia, Pennsylvania is a major site for these experiments."

Answered by AI

Are there any ongoing openings in this clinical trial?

"This trial is no longer accepting applications. It was first published on February 21st 2019 and last edited on October 7th 2022. Individuals looking for other research opportunities can find 2597 cancer-related studies currently recruiting, as well as 1511 trials involving Cytokine-based Biologic Agent IRX-2 that are actively enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "IRX-2, Cyclophosphamide, and Nivolumab in Treating Patients With Recurrent or Metastatic and Refractory Liver Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03655002.

All > Liver Cancer