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Checkpoint Inhibitor
Immunotherapy for Pediatric Liver Cancer
Phase 2
Recruiting
Research Sponsored by Allison O'Neill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmation of Insurance Pre-authorization approval for Pembrolizumab.
2 to <6 years 0.8 0.8
Must not have
Participants who are receiving anti-inflammatory or immunosuppressive medications are not eligible.
Patients with a history of a positive test for human immunodeficiency virus or acquired immunodeficiency syndrome are not eligible.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Summary
This trial is testing an immunotherapy drug to see if it can treat pediatric liver cancer.
Who is the study for?
This trial is for children and young adults under 30 with pediatric hepatocellular carcinoma or HCN NOS that's come back or didn't respond to treatment. They must have normal organ function, no recent radiation therapy, and not be on steroids or immunosuppressants. Participants need a negative pregnancy test if applicable and agree to use contraception.
What is being tested?
The study tests Pembrolizumab (KEYTRUDA), an immunotherapy drug, as a potential treatment for liver cancer in the pediatric population. It aims to see how effective it is in treating relapsed/refractory cases of hepatocellular carcinoma in this age group.
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation of organs, infusion reactions similar to allergic responses, fatigue, skin rash, digestive issues like diarrhea or colitis, hormone gland problems (like thyroid dysfunction), and can increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My insurance has approved the use of Pembrolizumab for my treatment.
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My child is between 2 and less than 6 years old.
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I haven't had radiotherapy in the last week and have recovered from any side effects.
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I have a tumor that can be measured by scans or physical exam.
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I am younger than 30 years old.
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My kidney function is good, with a creatinine clearance rate of 60 mL/min or higher.
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I am between 6 and 9 years old.
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I am mostly able to care for myself and carry out daily activities.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking any anti-inflammatory or immunosuppressive medications.
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I have never tested positive for HIV/AIDS.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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I am not on long-term steroids exceeding the specified doses.
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I have not taken any PD-1, PD-L1, or CTLA-4 inhibitors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Immune-related best overall response (irBOR)
Secondary study objectives
DNA sequencing of specimens
Expression levels of infiltrating immune cells and markers of checkpoint inhibition on pre-treatment specimens
Number of Participants with DLT
+2 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: PembrolizumabExperimental Treatment1 Intervention
Pembrolizumab will be administered every 3 weeks at a dose of 2mg/kg/dose (max: 200mg) with 21 consecutive days defined as a treatment cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
Allison O'NeillLead Sponsor
Allison O'Neill, MDLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 16 years.I haven't had any cancer treatment in the last 14 days.My organ and bone marrow functions are normal.My thyroid function is normal.My insurance has approved the use of Pembrolizumab for my treatment.My kidney function, measured by creatinine levels, is within the normal range for my age and gender.I have recovered from side effects of my previous cancer treatments.I am not taking any anti-inflammatory or immunosuppressive medications.My liver cancer has returned or didn't respond to treatment.My kidney function, based on my age and gender, is within the required range.My kidney function is normal.My child is between 2 and less than 6 years old.I haven't had radiotherapy in the last week and have recovered from any side effects.My bone marrow is working well.I have a tumor that can be measured by scans or physical exam.I have never tested positive for HIV/AIDS.My thyroid function is normal or controlled with medication.I can provide a tumor sample for testing.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am between 10 and less than 13 years old.This criterion does not apply to me.I am younger than 30 years old.I haven't had antibody therapy recently.I am not on long-term steroids exceeding the specified doses.I have not taken any PD-1, PD-L1, or CTLA-4 inhibitors.My kidney function is good, with a creatinine clearance rate of 60 mL/min or higher.My liver is working well.I am between 6 and 9 years old.I am mostly able to care for myself and carry out daily activities.I am between 13 and less than 16 years old.You have had severe allergic reactions to drugs similar to pembrolizumab, or you have had a serious allergic reaction to other monoclonal antibody treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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