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PD-1 Inhibitor
Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) for Advanced Melanoma in Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/L1)-Exposed Participants (MK-7902-004/E7080-G000-225/LEAP-004)
Lismore, Australia
Phase 2
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 55 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the safety and effectiveness of two drugs, lenvatinib and pembrolizumab, given after exposure to other anti-melanoma agents. There is no specific hypothesis being tested.
Eligible Conditions
- Skin Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 55 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 55 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate (ORR)
Secondary study objectives
Area Under the Concentration Time Curve of Lenvatinib From Time 0 to Infinity (AUC 0-inf)
Duration of Response (DOR)
Number of Participants Who Discontinue Study Treatment Due to an AE
+3 moreSide effects data
From 2024 Phase 3 trial • 794 Patients • NCT0371359347%
Diarrhoea
45%
Hypertension
42%
Hypothyroidism
37%
Decreased appetite
34%
Palmar-plantar erythrodysaesthesia syndrome
33%
Proteinuria
32%
Fatigue
30%
Weight decreased
29%
Aspartate aminotransferase increased
26%
Blood bilirubin increased
25%
Platelet count decreased
23%
Alanine aminotransferase increased
23%
Nausea
22%
Arthralgia
21%
Dysphonia
18%
Abdominal pain
18%
Asthenia
17%
Pruritus
17%
Constipation
16%
Gamma-glutamyltransferase increased
16%
Rash
16%
Oedema peripheral
15%
Hypoalbuminaemia
14%
Lipase increased
14%
Back pain
13%
Cough
13%
Vomiting
12%
Blood alkaline phosphatase increased
12%
Headache
12%
Anaemia
11%
Abdominal pain upper
11%
Pyrexia
11%
Hyponatraemia
11%
Dyspnoea
10%
Amylase increased
10%
Blood creatinine increased
10%
Stomatitis
9%
Hypokalaemia
9%
Insomnia
9%
Neutrophil count decreased
9%
Urinary tract infection
8%
Hyperthyroidism
8%
Dyspepsia
7%
Abdominal distension
7%
White blood cell count decreased
7%
Haematuria
7%
Ascites
6%
Hypertriglyceridaemia
6%
Myalgia
6%
Dizziness
6%
Toothache
6%
Mucosal inflammation
6%
Hyperglycaemia
6%
Hypomagnesaemia
6%
Epistaxis
5%
Hypophosphataemia
5%
Pain in extremity
5%
Dysgeusia
5%
Oropharyngeal pain
5%
Hepatic encephalopathy
5%
Neutropenia
5%
Dry mouth
5%
Malaise
3%
Hyperkalaemia
2%
Pneumonia
2%
General physical health deterioration
1%
Pancreatitis
1%
Pneumonia klebsiella
1%
Hepatic pain
1%
Septic shock
1%
Tumour haemorrhage
1%
Hepatic failure
1%
Angina pectoris
1%
Myocardial infarction
1%
Gastric ulcer haemorrhage
1%
Gastrointestinal haemorrhage
1%
Hepatorenal syndrome
1%
COVID-19
1%
COVID-19 pneumonia
1%
Atrial fibrillation
1%
Immune thrombocytopenia
1%
Acute myocardial infarction
1%
Adrenal insufficiency
1%
Hypophysitis
1%
Colitis
1%
Gastric haemorrhage
1%
Haemorrhoidal haemorrhage
1%
Death
1%
Multiple organ dysfunction syndrome
1%
Immune-mediated hepatitis
1%
Sepsis
1%
Dehydration
1%
Diabetic ketoacidosis
1%
Hypoglycaemia
1%
Tumour lysis syndrome
1%
Cerebrovascular accident
1%
Depressed level of consciousness
1%
Ischaemic stroke
1%
Seizure
1%
Acute kidney injury
1%
Pemphigoid
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lenvatinib + Placebo
Lenvatinib + Pembrolizumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: lenvatinib plus pembrolizumabExperimental Treatment2 Interventions
Participants receive lenvatinib 20 mg 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5890
lenvatinib
2018
Completed Phase 3
~1950
Find a Location
Closest Location:Princess Margaret Cancer Centre ( Site 0655)· Toronto, Canada
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,502 Total Patients Enrolled
Eisai Inc.Industry Sponsor
522 Previous Clinical Trials
160,532 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,032 Previous Clinical Trials
5,189,613 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,905 Previous Clinical Trials
8,091,386 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tried a specific type of medicine called anti-PD-1/L1 monoclonal antibody, either alone or with other similar treatments, but your condition has not improved.Your organs are working properly.You have spreading cancer in your brain or spinal fluid.You have melanoma in your eye.You have a gastrointestinal condition that can affect how your body absorbs lenvatinib.You have a severe fistula in your digestive system or other parts of your body.You have had a serious allergic reaction to a medication similar to the one being tested.You have a history of lung disease that required steroid treatment or currently have lung disease.You have received a transplant of someone else's tissue or organ.You have another type of cancer that is getting worse or needs ongoing treatment.You have experienced significant coughing up blood or bleeding from your tumor within the past 2 weeks before starting the study drug.
Research Study Groups:
This trial has the following groups:- Group 1: lenvatinib plus pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.