← Back to Search

PD-1 Inhibitor

Pembrolizumab for Hepatocellular Carcinoma

Phase 1
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after approximately 36 months
Awards & highlights

Study Summary

This trial will see if a new combo of drugs is safe and works against advanced liver cancer. They'll also look for biomarkers in blood and tissue.

Eligible Conditions
  • Hepatocellular Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after approximately 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and after approximately 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicities(DLTs)
Incidence of treatment-emergent adverse event(TEAEs)
Severity of TEAEs
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DOR)
Disease
+5 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
Group I: Dose expansionExperimental Treatment2 Interventions
Dose expansion cohorts will continue to be expanded until the sample size of 30-35 patients per cohort is reached.
Group II: Dose escalationExperimental Treatment2 Interventions
The regorafenib starting dose will be 120 mg q.d.(once daily) 3 weeks on / 1 week off in combination with the recommended dose of pembrolizumab (200 mg Q3W). Pembrolizumab dose will not be escalated or de-escalated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regorafenib(Stivarga, BAY73-4506)
2018
Completed Phase 1
~60
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,059,877 Total Patients Enrolled
25 Trials studying Hepatocellular Carcinoma
5,743 Patients Enrolled for Hepatocellular Carcinoma
BayerLead Sponsor
2,240 Previous Clinical Trials
25,332,719 Total Patients Enrolled
17 Trials studying Hepatocellular Carcinoma
2,769 Patients Enrolled for Hepatocellular Carcinoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Regorafenib Plus Pembrolizumab in First Line Systemic Treatment of HCC
2018. "Regorafenib Plus Pembrolizumab in First Line Systemic Treatment of HCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03347292.
~8 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top