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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing whether two immunotherapy drugs can help shrink tumors in patients with liver cancer that has spread.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
Select...
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.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Heart rate
Secondary outcome measures
Disease control
Incidence of adverse events
Overall survival (OS)
+1 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Syncope
1%
Cancer pain
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
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
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,965 Total Patients Enrolled
44 Trials studying Hepatocellular Carcinoma
6,310 Patients Enrolled for Hepatocellular Carcinoma
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,096 Total Patients Enrolled
Mehmet AkcePrincipal InvestigatorAcademic and Community Cancer Research United
2 Previous Clinical Trials
49 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer spread to the lining of my brain and spinal cord.I have not had a heart attack in the last 6 months and don't need ongoing therapy for severe heart rhythm problems.My liver function is mildly affected.I had liver treatment over a month ago and have at least one untreated tumor.My condition cannot be treated with surgery.I am immunocompromised or HIV positive and on antiretroviral therapy.I've had atezolizumab and bevacizumab but need a new treatment due to cancer growth.I had severe side effects from a previous immunotherapy with atezolizumab.I am 18 years old or older.My liver cancer is at an advanced stage and cannot be treated with surgery or localized therapies.I don't have lasting side effects from cancer treatment, except for hair loss or skin changes.I haven't taken strong immune-suppressing drugs in the last 2 weeks, except for minor exceptions like inhalers or low-dose steroids.I do not have active autoimmune or inflammatory disorders, except for allowed conditions.I do not have an active infection like TB, and if I have hepatitis, it is under control.I have not received anti-CTLA-4 antibody treatment for liver cancer in the last 4 weeks.I have not had major surgery in the last 4 weeks.I have received an organ transplant from another person.I haven't taken any experimental drugs for my cancer in the last 4 weeks.I haven't had any cancer except for skin cancer or cervical pre-cancer in the last 2 years.My liver cancer diagnosis was confirmed by a doctor.I have not received a live vaccine in the last 30 days.I have signed the consent form for this trial within the last 28 days.I have not rapidly progressed on atezolizumab and bevacizumab treatment.It has been at least 4 weeks since my last dose of atezolizumab and bevacizumab.I do not have any severe illnesses that could interfere with the study.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nivolumab, ipilimumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Nivolumab for clinical use?
"Our team at Power has assigned nivolumab a score of 2 on the safety scale, due to the data collected during Phase 2 clinical trials that confirm its relative security but lack evidence for efficacy."
Answered by AI
Is enrollment open for this research endeavor?
"Unfortunately, the trial listing on clinicaltrials.gov reveals that this medical study is no longer accepting participants; it was posted on November 30th of 2022 and last updated September 23rd. Nonetheless, there are still 2598 other trials beckoning for recruits at present time."
Answered by AI
What is the geographic scope of this trial's management?
"There are 6 sites across the nation that currently have open slots for this medical trial. Examples include Emory University Hospital/Winship Cancer Institute in Atlanta, University of Miami Miller Schoolof Medicine-Sylvester Cancer Center in Miami, and Rutgers Cancer Institute of New jersey in New Brunswick."
Answered by AI
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