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PD-1 Inhibitor
lenvatinib for Melanoma
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 3 years
Awards & highlights
Study 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
- Advanced Melanoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
Secondary outcome measures
Area Under the Concentration Time Curve of Lenvatinib From Time 0 to Infinity (AUC 0-inf)
Duration of Response (DOR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
Overall Survival (OS)
+3 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
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
~5750
lenvatinib
2018
Completed Phase 2
~270
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,725 Total Patients Enrolled
31 Trials studying Melanoma
9,359 Patients Enrolled for Melanoma
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
153,917 Total Patients Enrolled
14 Trials studying Melanoma
1,585 Patients Enrolled for Melanoma
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,450 Total Patients Enrolled
120 Trials studying Melanoma
21,580 Patients Enrolled for Melanoma
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How is lenvatinib indicated for use?
"Lenvatinib can be an effective treatment for various cancers, such as malignant neoplasms and unresectable melanoma. Additionally, it is sometimes used to treat patients with microsatellite instability high."
Answered by AI
Has the FDA given lenvatinib their stamp of approval?
"While there is some data supporting lenvatinib's safety, it is still in Phase 2 clinical trials and has not yet been proven effective."
Answered by AI
Does lenvatinib have a history of being studied in other medical trials?
"There are 1076 ongoing clinical trials researching lenvatinib. Of these, 134 have reached Phase 3. The majority of these studies taking place in Sacramento, California; however, there are 37371 locations running trials for this medication globally."
Answered by AI
Is this study taking place at a high number of locations within the US?
"More than a handful of locations are running this clinical trial; 10 in total. To name a few, there is Sunnybrook Research Institute (Site 0654) in Toronto, Southeast Nebraska Cancer Center (0316) in Lincoln and McGill University Health Centre (0651) in Montreal."
Answered by AI
Are there any patients who have not yet been enrolled in this research?
"No, this particular clinical trial is not currently looking for new patients. The study was initially posted on 1/30/2019, with the most recent edit taking place on 7/21/2022. There are other options available; as of right now, there are 783 trials actively recruiting melanoma patients and 1076 trials involving lenvatinib that have open enrolment."
Answered by AI
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