← Back to Search

Tyrosine Kinase Inhibitor

Lenvatinib + 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
Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach
Has a diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 41 months
Awards & highlights

Study Summary

This trial will study if adding pembrolizumab to lenvatinib will help people with advanced hepatocellular carcinoma live longer without the cancer growing, and if it is safe.

Who is the study for?
Adults over 18 with advanced hepatocellular carcinoma (a type of liver cancer) who haven't had certain treatments like anti-PD-1 or systemic chemotherapy for HCC in the past 3 years. They should be physically capable (ECOG status 0-1), have a life expectancy over 3 months, and not have conditions that could affect study participation or drug absorption.Check my eligibility
What is being tested?
The trial is testing if combining lenvatinib, a cancer medication, with pembrolizumab, an immunotherapy drug, is more effective than lenvatinib alone for first-line treatment of liver cancer. The main goal is to see if this combination improves survival without the disease getting worse.See study design
What are the potential side effects?
Possible side effects include high blood pressure, fatigue, diarrhea, decreased appetite and weight loss from lenvatinib; pembrolizumab may cause immune system-related side effects such as inflammation in organs like lungs or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My liver cancer is at a stage where it can't be cured with surgery or local treatments.
Select...
My liver cancer diagnosis was confirmed through imaging or lab tests.
Select...
My liver is functioning well.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have a liver cancer lesion that can be measured.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 41 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 41 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
Overall Survival (OS)
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Secondary outcome measures
Disease Control Rate (DCR) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Duration of Response (DOR) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
+11 more

Side effects data

From 2021 Phase 2 trial • 41 Patients • NCT02915783
71%
Fatigue
58%
Diarrhoea
58%
Nausea
55%
Decreased appetite
52%
Vomiting
39%
Stomatitis
39%
Weight decreased
32%
Hypertension
29%
Abdominal pain
29%
Proteinuria
29%
Dyspnoea
26%
Insomnia
26%
Arthralgia
26%
Headache
26%
Epistaxis
23%
Anxiety
23%
Dysphonia
19%
Hypothyroidism
19%
Constipation
19%
Dyspepsia
19%
Blood creatinine increased
19%
Back pain
19%
Cough
19%
Nasal congestion
16%
Oedema peripheral
16%
Pain in extremity
16%
Muscular weakness
16%
Musculoskeletal chest pain
16%
Pruritus
13%
Hypertriglyceridaemia
13%
Anaemia
13%
Hypomagnesaemia
13%
Toothache
13%
Oral pain
13%
Abdominal pain upper
13%
Dry mouth
13%
Gastrooesophageal reflux disease
13%
Asthenia
13%
Sinusitis
13%
Dizziness
13%
Dysgeusia
13%
Oropharyngeal pain
13%
Palmar-plantar erythrodysaesthesia syndrome
13%
Hypotension
13%
Platelet count decreased
13%
Dehydration
13%
Hyperglycaemia
10%
Thrombocytopenia
10%
Rash
10%
Influenza like illness
10%
Pain
10%
Peripheral swelling
10%
Depression
10%
Haematuria
10%
Eye swelling
10%
Urinary tract infection
10%
Fall
10%
Alanine aminotransferase increased
10%
Blood cholesterol increased
10%
Malignant neoplasm progression
10%
Peripheral sensory neuropathy
10%
Pneumonitis
10%
Productive cough
10%
Sinus congestion
10%
Alopecia
10%
Dermatitis acneiform
10%
Blood triglycerides increased
10%
Lipase increased
6%
Skin exfoliation
6%
Rash maculo-papular
6%
Hyponatraemia
6%
Cancer pain
6%
Non-cardiac chest pain
6%
Bronchitis
6%
Folliculitis
6%
Gastroenteritis viral
6%
Nasopharyngitis
6%
Pneumonia
6%
Tremor
6%
Bone pain
6%
Acute kidney injury
6%
Dysuria
6%
Palpitations
6%
Flatulence
6%
Chills
6%
Upper respiratory tract infection
6%
Contusion
6%
Rib fracture
6%
Aspartate aminotransferase increased
6%
Blood alkaline phosphatase increased
6%
Hypophosphataemia
6%
Musculoskeletal pain
6%
Myalgia
6%
Taste disorder
6%
Nocturia
6%
Pollakiuria
6%
Urinary retention
6%
Hiccups
6%
Upper-airway cough syndrome
6%
Dry skin
6%
Swelling face
6%
Abdominal discomfort
6%
Hyperkalaemia
3%
Pruritus generalised
3%
Sensitive skin
3%
Atrial fibrillation
3%
Malignant ascites
3%
Hypokalaemia
3%
International normalised ratio increased
3%
Cerebrovascular accident
3%
Skin toxicity
3%
Rash macular
3%
Lipids increased
3%
Tinnitus
3%
Abdominal pain lower
3%
Haemoptysis
3%
Hypoacusis
3%
Abdominal tenderness
3%
Angina pectoris
3%
Oral dysaesthesia
3%
Retching
3%
Pyrexia
3%
Portal vein thrombosis
3%
Ear infection
3%
Furuncle
3%
Infection
3%
Ulnar nerve palsy
3%
Confusional state
3%
Vena cava thrombosis
3%
Cardiac failure congestive
3%
Hyperthyroidism
3%
Joint stiffness
3%
Joint swelling
3%
Limb discomfort
3%
Neck pain
3%
Tumour pain
3%
Balance disorder
3%
Hallucination
3%
Hepatic encephalopathy
3%
Pleuritic pain
3%
Sepsis
3%
Atrial tachycardia
3%
Cardiac failure
3%
Cyanosis
3%
Stress cardiomyopathy
3%
External ear pain
3%
Dry eye
3%
Vision blurred
3%
Abdominal distension
3%
Anal fissure
3%
Glossodynia
3%
Haematochezia
3%
Lip pain
3%
Odynophagia
3%
Chest discomfort
3%
Crepitations
3%
Facial pain
3%
Eye infection
3%
Respiratory syncytial virus infection
3%
Tooth abscess
3%
Accidental overdose
3%
Skin abrasion
3%
Amylase increased
3%
Aspartate aminotransferase abnormal
3%
Blood lactate dehydrogenase increased
3%
Blood potassium decreased
3%
Muscle spasms
3%
Malignant pleural effusion
3%
Melanocytic naevus
3%
Carpal tunnel syndrome
3%
Cerebral haematoma
3%
Dizziness postural
3%
Hypoaesthesia
3%
Irregular sleep wake rhythm disorder
3%
Memory impairment
3%
Radicular pain
3%
Sciatica
3%
Renal pain
3%
Benign prostatic hyperplasia
3%
Vaginal discharge
3%
Bronchiectasis
3%
Pulmonary pain
3%
Respiration abnormal
3%
Respiratory tract congestion
3%
Rhinorrhoea
3%
Throat irritation
3%
Blister
3%
Hyperkeratosis
3%
Nail disorder
3%
Skin ulcer
3%
Flushing
3%
Hot flush
3%
Jugular vein thrombosis
3%
Cold sweat
3%
Gastrointestinal toxicity
3%
Asymptomatic bacteriuria
3%
Impetigo
3%
Injection site abscess
3%
Tooth infection
3%
Cardiac arrest
3%
Faecaloma
3%
Gastric ulcer
3%
Intestinal obstruction
3%
Lower gastrointestinal haemorrhage
3%
Upper gastrointestinal haemorrhage
3%
Blood thyroid stimulating hormone decreased
3%
Blood thyroid stimulating hormone increased
3%
Blood urea increased
3%
Heart sounds abnormal
3%
Neutrophil count decreased
3%
Platelet count increased
3%
Specific gravity urine increased
3%
Vitamin D decreased
3%
Fluid retention
3%
Hypercalcaemia
3%
Hypercholesterolaemia
3%
Hypernatraemia
3%
White blood cell count decreased
3%
Hypoglycaemia
3%
Deep vein thrombosis
3%
Pleural effusion
3%
Paraesthesia
3%
Groin pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lenvatinib 18 mg/Day + Everolimus 5 mg/Day

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: lenvatinib plus pembrolizumabExperimental Treatment2 Interventions
Participants receive lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight <60 kg) orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity.
Group II: lenvatinib plus placeboActive Control2 Interventions
Participants receive lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight <60 kg) orally QD plus saline placebo by IV infusion on Day 1 Q3W. Saline placebo will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
lenvatinib
2018
Completed Phase 2
~270
pembrolizumab
2018
Completed Phase 3
~6240

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,117 Total Patients Enrolled
6 Trials studying Hepatocellular Carcinoma
2,707 Patients Enrolled for Hepatocellular Carcinoma
Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,048,906 Total Patients Enrolled
24 Trials studying Hepatocellular Carcinoma
5,639 Patients Enrolled for Hepatocellular Carcinoma
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
153,305 Total Patients Enrolled
5 Trials studying Hepatocellular Carcinoma
380 Patients Enrolled for Hepatocellular Carcinoma

Media Library

Lenvatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03713593 — Phase 3
Hepatocellular Carcinoma Research Study Groups: lenvatinib plus pembrolizumab, lenvatinib plus placebo
Hepatocellular Carcinoma Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT03713593 — Phase 3
Lenvatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03713593 — Phase 3

Frequently Asked Questions

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

What are some of the approved medical conditions that lenvatinib is used to manage?

"Lenvatinib has been shown to be effective in treating malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

Is this experiment still looking for test subjects?

"This particular trial is not currently recruiting patients. However, there are 2668 other trials involving carcinoma, hepatocellular patients and 1076 trials involving lenvatinib that are actively looking for participants."

Answered by AI

What does the current research say about lenvatinib's efficacy?

"Currently, there are 1076 ongoing studies researching lenvatinib with 134 trials in Phase 3. The majority of the clinical trials for lenvatinib are running in Zaragoza, California, however, there are 37193 locations worldwide operating trials for lenvatinib."

Answered by AI

What are the most common lenvatinib side effects that patients experience?

"Lenvatinib safety was rated a 3 by our Power team. This is due to the fact that it is a Phase 3 trial, which implies that there is both efficacy and safety data from multiple rounds of testing."

Answered by AI

What is the patient limit for this research project?

"Unfortunately, this particular clinical trial is not currently taking on any more participants. However, there are 2668 other trials for patients with carcinoma, hepatocellular and 1076 trials for lenvatinib that are currently looking for patients."

Answered by AI
~129 spots leftby Mar 2025