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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~8 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have provided a tumor tissue sample during my screening.
Select...
My scans show no cancer signs 4 weeks after surgery or local treatment.
Select...
I have been diagnosed with liver cancer through imaging tests or biopsy.
Select...
My hepatitis B is under control.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Recurrence-Free Survival (RFS)
Secondary outcome measures
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 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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 2
~2010

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,872 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,053,621 Total Patients Enrolled
2 Trials studying Liver Cancer
133 Patients Enrolled for Liver Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,530 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Where are patients able to receive this experimental treatment?

"This study is enrolling at 16 different sites, including James Graham Brown Cancer Center (Site 0088) in Louisville, University of Cincinnati Medical Center (Site 0084) in Cincinnati, and Miami Valley Hospital South (Site 0093) in Centerville."

Answered by AI

What is the total number of people who have signed up for this clinical trial?

"enrolment for this study is currently closed. The posting dates were from May 28th, 2019 to August 10th, 2022. If you're looking for other opportunities, 2689 trials are actively recruiting patients with carcinoma and 1000 trials require Pembrolizumab volunteers."

Answered by AI

For what purpose is Pembrolizumab most commonly prescribed?

"Pembrolizumab is a common treatment for malignant neoplasms, and can also be used to treat unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."

Answered by AI

Has Pembrolizumab received FDA authorization?

"Pembrolizumab has received a Phase 3 safety rating from our team at Power, meaning that while there is some efficacy data supporting its use, multiple rounds of testing have confirmed its safety."

Answered by AI

Why was this clinical trial started in the first place?

"The primary outcome of this long-term study is Recurrence-Free Survival (RFS), which will be monitored over a period of six years. Additionally, the research team will assess Time to Deterioration (TTD) in the EORTC QLQ-HCC18 Scale Score, Change from Baseline in European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Health Utility Score, and Percentage of Participants who Experience an Adverse Event (AE)."

Answered by AI

Pembrolizumab has been trialed before, correct? Could you tell us a bit about those other trials?

"Pembrolizumab is being researched in 1000 ongoing trials, with 122 of those in Phase 3. Pembrolizumab's clinical trials are hosted at 36021 locations worldwide, including Houston, Texas."

Answered by AI

Are new participants currently being welcomed into this experiment?

"According to the latest information on clinicaltrials.gov, this study is not currently recruiting patients for participation. The trial was first posted on May 28th, 2019 and was edited most recently on August 10th, 2020. Despite this particular study not being open for recruitment, there are 3689 other studies that are actively looking for candidates right now."

Answered by AI
~395 spots leftby Oct 2027