Your session is about to expire
← 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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 41 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 41 months
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 moreSide effects data
From 2021 Phase 2 trial • 41 Patients • NCT0291578371%
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
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
2017
Completed Phase 3
~5750
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,812 Total Patients Enrolled
6 Trials studying Hepatocellular Carcinoma
2,707 Patients Enrolled for Hepatocellular Carcinoma
Merck Sharp & Dohme LLCLead Sponsor
3,896 Previous Clinical Trials
5,061,924 Total Patients Enrolled
25 Trials studying Hepatocellular Carcinoma
5,743 Patients Enrolled for Hepatocellular Carcinoma
Eisai Inc.Industry Sponsor
516 Previous Clinical Trials
158,242 Total Patients Enrolled
5 Trials studying Hepatocellular Carcinoma
362 Patients Enrolled for Hepatocellular Carcinoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had major heart problems or strokes in the last year.I have had pneumonitis treated with steroids or have it now.I have been treated with specific immune therapy for cancer.I have been treated for an autoimmune disease in the last 2 years.I have a condition that affects how my body absorbs medication.I am 18 years or older.I have had significant coughing up of blood or tumor bleeding in the last 2 weeks.I have a severe fistula.My heart's pumping ability is below normal.I have another cancer besides skin cancer or in situ cancers that hasn't needed treatment in the last 3 years.I have received an organ or tissue transplant from another person.My liver cancer is at a stage where it can't be cured with surgery or local treatments.I had major liver surgery less than 4 weeks ago.I have active tuberculosis.I have an infection that needs treatment, but it's not HBV or HCV.I have had bleeding from varices in my esophagus or stomach in the past 6 months.I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.My liver cancer diagnosis was confirmed through imaging or lab tests.My hepatitis B is under control.My liver is functioning well.I have or had cancer spread to my brain or spinal cord.I have not had chemotherapy for liver cancer or any cancer in the last 3 years.I am fully active or restricted in physically strenuous activity but can do light work.I have a serious wound or broken bone that is not healing.I had a minor surgery less than a week ago.I have a liver cancer lesion that can be measured.
Research Study Groups:
This trial has the following groups:- Group 1: lenvatinib plus pembrolizumab
- Group 2: lenvatinib plus placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger