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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.
Select...
I have had up to three treatments for my cancer that has returned or spread.
Select...
I am fully active or can carry out light work.
Select...
My kidney function, measured by creatinine clearance, is above 40 mL/min.
Select...
My liver cancer has returned or spread.
Select...
I have at least one tumor that can be measured.
Select...
I have tried at least one treatment for advanced liver cancer that didn't work or I couldn't tolerate.

Timeline

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%
0%
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
~3780
Cytokine-based Biologic Agent IRX-2
2019
Completed Phase 2
~10
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,636 Previous Clinical Trials
40,929,541 Total Patients Enrolled
44 Trials studying Hepatocellular Carcinoma
6,331 Patients Enrolled for Hepatocellular Carcinoma
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,659 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
~1 spots leftby Dec 2024