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Tyrosine Kinase Inhibitor

lenvatinib for Liver Cancer

Phase 1
Waitlist Available
Research Sponsored by Eisai Co., Ltd.
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 from the date of first dose of study drug until date of death from any cause (up to 48.1 months)
Awards & highlights

Study Summary

This trial will study if a combination of lenvatinib and pembrolizumab is safe and tolerable for people with hepatocellular carcinoma. Objective response rate and duration of response will be measured.

Eligible Conditions
  • Liver Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of first dose of study drug until date of death from any cause (up to 48.1 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first dose of study drug until date of death from any cause (up to 48.1 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
DLT Part: Number of Participants With Dose Limiting Toxicities (DLTs)
DLT Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
DLT+Expansion Part: Duration of Response (DOR) Based on RECIST v1.1 Assessed by IIR
+3 more
Secondary outcome measures
DLT+Expansion Part, %PTF: Percent (%) Peak-trough Fluctuation for Lenvatinib
DLT+Expansion Part, AUC(0-Inf): Area Under the Plasma Concentration-time Curve From Zero to Infinity for Lenvatinib
DLT+Expansion Part, AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero Time to the Last Measurable Point for Lenvatinib
+25 more

Side effects data

From 2021 Phase 2 trial • 41 Patients • NCT02915783
71%
Fatigue
58%
Nausea
58%
Diarrhoea
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%
Dysphonia
23%
Anxiety
19%
Dyspepsia
19%
Cough
19%
Nasal congestion
19%
Hypothyroidism
19%
Constipation
19%
Blood creatinine increased
19%
Back pain
16%
Oedema peripheral
16%
Pain in extremity
16%
Pruritus
16%
Muscular weakness
16%
Musculoskeletal chest pain
13%
Gastrooesophageal reflux disease
13%
Dry mouth
13%
Oropharyngeal pain
13%
Anaemia
13%
Sinusitis
13%
Hypertriglyceridaemia
13%
Hypotension
13%
Hypomagnesaemia
13%
Palmar-plantar erythrodysaesthesia syndrome
13%
Toothache
13%
Oral pain
13%
Abdominal pain upper
13%
Asthenia
13%
Dizziness
13%
Dysgeusia
13%
Platelet count decreased
13%
Dehydration
13%
Hyperglycaemia
10%
Thrombocytopenia
10%
Eye swelling
10%
Pain
10%
Urinary tract infection
10%
Influenza like illness
10%
Fall
10%
Alanine aminotransferase increased
10%
Peripheral sensory neuropathy
10%
Pneumonitis
10%
Rash
10%
Productive cough
10%
Haematuria
10%
Dermatitis acneiform
10%
Peripheral swelling
10%
Depression
10%
Blood cholesterol increased
10%
Malignant neoplasm progression
10%
Sinus congestion
10%
Alopecia
10%
Blood triglycerides increased
10%
Lipase increased
6%
Non-cardiac chest pain
6%
Pneumonia
6%
Cancer pain
6%
Bone pain
6%
Abdominal discomfort
6%
Flatulence
6%
Hiccups
6%
Nasopharyngitis
6%
Upper respiratory tract infection
6%
Folliculitis
6%
Gastroenteritis viral
6%
Rib fracture
6%
Taste disorder
6%
Contusion
6%
Hyponatraemia
6%
Dry skin
6%
Acute kidney injury
6%
Skin exfoliation
6%
Swelling face
6%
Nocturia
6%
Rash maculo-papular
6%
Dysuria
6%
Pollakiuria
6%
Bronchitis
6%
Tremor
6%
Palpitations
6%
Chills
6%
Aspartate aminotransferase increased
6%
Blood alkaline phosphatase increased
6%
Hypophosphataemia
6%
Musculoskeletal pain
6%
Myalgia
6%
Urinary retention
6%
Upper-airway cough syndrome
6%
Hyperkalaemia
3%
Upper gastrointestinal haemorrhage
3%
Angina pectoris
3%
Atrial tachycardia
3%
Haematochezia
3%
Cerebrovascular accident
3%
Dry eye
3%
Lower gastrointestinal haemorrhage
3%
Pyrexia
3%
International normalised ratio increased
3%
Hepatic encephalopathy
3%
Tinnitus
3%
Pleuritic pain
3%
Abdominal distension
3%
Intestinal obstruction
3%
Hyperthyroidism
3%
Malignant ascites
3%
Sepsis
3%
Lip pain
3%
Tooth abscess
3%
Memory impairment
3%
Vision blurred
3%
Atrial fibrillation
3%
Abdominal pain lower
3%
Accidental overdose
3%
Odynophagia
3%
Skin abrasion
3%
Eye infection
3%
Respiratory syncytial virus infection
3%
Hypokalaemia
3%
Joint stiffness
3%
Nail disorder
3%
Infection
3%
Furuncle
3%
Amylase increased
3%
Aspartate aminotransferase abnormal
3%
Blood potassium decreased
3%
Blister
3%
Haemoptysis
3%
Neck pain
3%
Radicular pain
3%
Hot flush
3%
Flushing
3%
Rash macular
3%
Sciatica
3%
Hallucination
3%
Pruritus generalised
3%
Sensitive skin
3%
Vaginal discharge
3%
Bronchiectasis
3%
Pulmonary pain
3%
Hyperkeratosis
3%
Lipids increased
3%
Skin toxicity
3%
Skin ulcer
3%
Vena cava thrombosis
3%
Abdominal tenderness
3%
Cardiac failure congestive
3%
Hypoacusis
3%
Oral dysaesthesia
3%
Retching
3%
Portal vein thrombosis
3%
Ear infection
3%
Ulnar nerve palsy
3%
Confusional state
3%
Joint swelling
3%
Limb discomfort
3%
Tumour pain
3%
Balance disorder
3%
Cardiac failure
3%
Cyanosis
3%
Stress cardiomyopathy
3%
External ear pain
3%
Anal fissure
3%
Glossodynia
3%
Chest discomfort
3%
Crepitations
3%
Facial pain
3%
Blood lactate dehydrogenase increased
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%
Renal pain
3%
Benign prostatic hyperplasia
3%
Respiration abnormal
3%
Respiratory tract congestion
3%
Rhinorrhoea
3%
Throat irritation
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%
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

1Treatment groups
Experimental Treatment
Group I: lenvatinib 8 or 12 mg plus pembrolizumab 200 mgExperimental Treatment2 Interventions
Participants will receive oral lenvatinib at a starting dose of 8 or 12 milligrams (mg) once a day (QD) in combination with intravenous pembrolizumab 200 mg every 3 weeks (Q3W) on a 21-day treatment cycle. The starting dose of lenvatinib will be based on Baseline body weight. Participants weighing greater than or equal to 60 kilograms (kg) will receive 12 mg QD; participants weighing less than 60 kg will receive 8 mg QD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
lenvatinib
2018
Completed Phase 2
~270
pembrolizumab (200 mg)
2017
Completed Phase 1
~110

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,449 Total Patients Enrolled
2 Trials studying Liver Cancer
133 Patients Enrolled for Liver Cancer
Eisai Co., Ltd.Lead Sponsor
178 Previous Clinical Trials
660,221 Total Patients Enrolled

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
Journal of Clinical OncologyJournal
Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients with Unresectable Hepatocellular Carcinoma
Finn, Richard S., Masafumi Ikeda, Andrew X. Zhu, Max W. Sung, Ari D. Baron, Masatoshi Kudo, Takuji Okusaka, et al.. 2020. “Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients with Unresectable Hepatocellular Carcinoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.00808.
clinicaltrials.govStudy
A Trial of Lenvatinib Plus Pembrolizumab in Participants With Hepatocellular Carcinoma
2017. "A Trial of Lenvatinib Plus Pembrolizumab in Participants With Hepatocellular Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03006926.
~13 spots leftby Apr 2025
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