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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
All Individual Drugs Already Approved
No Placebo-Only Group

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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
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 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

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.

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

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04134559 — Phase 2
Liver Cancer Research Study Groups: Pembrolizumab
Liver Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04134559 — Phase 2
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04134559 — Phase 2
~0 spots leftby Jan 2025
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