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Pembrolizumab for Liver Cancer

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If undergoing surgical resection, has submitted a tumor tissue sample during Screening
Has an eligibility scan confirming complete radiological response ≥4 weeks after complete surgical resection or local ablation. Randomization needs to occur within 12 weeks of the date of surgical resection or local ablation
Must not have
Has known active tuberculosis (TB; Bacillus tuberculosis)
Has a known additional malignancy that is progressing or has required active antineoplastic treatment (including hormonal) or surgery within the past 3 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~8 years
Awards & highlights
Pivotal Trial

Summary

This trial will compare pembrolizumab to placebo to see if it can help prevent cancer from recurring in people who have had surgery or local ablation for HCC.

Who is the study for?
This trial is for people who've had liver cancer (HCC) treated with surgery or local ablation and show no signs of the disease on scans. They must be in good physical condition, not pregnant or breastfeeding, using effective contraception if applicable, have a stable liver function score (Child-Pugh class A), controlled hepatitis B, and no other recent cancers or certain infections like HIV.
What is being tested?
The study tests whether pembrolizumab, an immunotherapy drug, is better than a placebo at preventing cancer from coming back after treatment (recurrence-free survival) and improving overall survival rates in patients whose liver cancer was removed or destroyed.
What are the potential side effects?
Pembrolizumab can cause immune system-related side effects such as inflammation in various organs including lungs (pneumonitis), skin reactions, hormone gland problems (like thyroid disorders), infusion reactions during administration of the drug, fatigue, and may worsen pre-existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have provided a tumor tissue sample during my screening.
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My scans show no cancer signs 4 weeks after surgery or local treatment.
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I have been diagnosed with liver cancer through imaging tests or biopsy.
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My hepatitis B is under control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have active tuberculosis.
Select...
I have another cancer that is growing or was treated in the last 3 years.
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I have received treatment for liver cancer before, including experimental drugs.
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I have been treated with specific immune therapy drugs before.
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I've had a liver treatment that wasn't radiofrequency or microwave ablation.
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I have been diagnosed with brain function issues due to liver disease in the last 6 months.
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I have had bleeding from varices in my esophagus or stomach in the last 6 months.
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I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.
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I have or had lung inflammation that needed steroids.
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I am currently being treated for an infection.
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I have both Hepatitis B and C.
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I have been treated for an autoimmune disease in the last 2 years.
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I have noticeable fluid buildup in my abdomen.
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I am not on any cancer treatments or strong steroids not approved in this study.
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I have received an organ or tissue transplant from another person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~8 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
Overall Survival (OS)
Recurrence-Free Survival (RFS)
Secondary study objectives
Change from Baseline in EORTC QLQ-Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status (GHS) / Quality of Life (QoL) Scale Score
Change from Baseline in European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Health Utility Score
+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%
Systemic infection
1%
Clostridium difficile colitis
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
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PembrolizumabExperimental Treatment1 Intervention
Participants receive intravenous (IV) pembrolizumab at 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.
Group II: PlaceboPlacebo Group1 Intervention
Participants receive IV placebo on Day 1 of each 21-day cycle for up to 17 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3150

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,538 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,027 Previous Clinical Trials
5,187,853 Total Patients Enrolled
2 Trials studying Liver Cancer
134 Patients Enrolled for Liver Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,900 Previous Clinical Trials
8,089,484 Total Patients Enrolled

Media Library

Pembrolizumab Clinical Trial Eligibility Overview. Trial Name: NCT03867084 — Phase 3
Liver Cancer Research Study Groups: Pembrolizumab, Placebo
Liver Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03867084 — Phase 3
Pembrolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03867084 — Phase 3
~320 spots leftby Oct 2027
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