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Checkpoint Inhibitor

Immunotherapy for Liver Cancer

Phase 2

Recruiting

Led By Mehmet Akce

Research Sponsored by Academic and Community Cancer Research United

Eligibility Criteria Checklist

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

Must have

Child Pugh class A

Locally advanced, metastatic, or unresectable disease

Must not have

History of leptomeningeal carcinomatosis

History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if two drugs, nivolumab and ipilimumab, can shrink tumors in patients with advanced liver cancer who haven't responded to other treatments. These drugs help the immune system attack and kill cancer cells.

Who is the study for?

Adults with advanced liver cancer that has spread or can't be surgically removed, who have previously been treated with Atezolizumab + Bevacizumab and need a new treatment. They must meet specific health criteria like certain blood cell counts and liver function tests, not be pregnant or breastfeeding, use contraception if of childbearing potential, and cannot have had major surgery or other treatments recently.

What is being tested?

The trial is testing the combination of two immunotherapy drugs called Nivolumab and Ipilimumab to see if they can shrink tumors in patients with advanced liver cancer. These drugs may help the immune system fight the cancer more effectively.

What are the potential side effects?

Possible side effects include immune-related reactions that could affect various organs, fatigue, skin issues like rash or itching, digestive problems such as diarrhea or colitis, hormone gland problems (like thyroid dysfunction), and potentially severe allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My liver function is mildly affected.

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My condition cannot be treated with surgery.

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I've had atezolizumab and bevacizumab but need a new treatment due to cancer growth.

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I am 18 years old or older.

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My liver cancer is at an advanced stage and cannot be treated with surgery or localized therapies.

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My liver cancer diagnosis was confirmed by a doctor.

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It has been at least 4 weeks since my last dose of atezolizumab and bevacizumab.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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

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I have not had a heart attack in the last 6 months and don't need ongoing therapy for severe heart rhythm problems.

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I am immunocompromised or HIV positive and on antiretroviral therapy.

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I had severe side effects from a previous immunotherapy with atezolizumab.

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I have not received anti-CTLA-4 antibody treatment for liver cancer in the last 4 weeks.

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I have received an organ transplant from another person.

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I have not rapidly progressed on atezolizumab and bevacizumab treatment.

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I do not have any severe illnesses that could interfere with the study.

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

Heart rate

Secondary study objectives

Disease control

Incidence of adverse events

Overall survival (OS)

+1 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

Part A Cohort 1c: Arm N3+RT+TMZ

Part A Cohort 1d: Arm N3+RT

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

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, ipilimumab)Experimental Treatment2 Interventions

Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2015

Completed Phase 3

~3070

Nivolumab

2015

Completed Phase 3

~4010