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Tyrosine Kinase Inhibitor
Lenvatinib + Pembrolizumab for Head and Neck Cancer
Phase 2
Recruiting
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
Male participants must refrain from sperm donation, be abstinent from heterosexual intercourse, or use contraception
Hepatitis B surface antigen positive participants must have received antiviral therapy and have undetectable viral load
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4 years
Awards & highlights
Study Summary
This trial is designed to see if adding lenvatinib to pembrolizumab or using lenvatinib alone is better than standard chemotherapy at treating head and neck squamous cell carcinoma that has progressed after platinum therapy and a PD-1 or anti-PD-L1 inhibitor.
Who is the study for?
This trial is for adults with recurrent/metastatic head and neck squamous cell carcinoma that worsened after platinum therapy and anti-PD-1/PD-L1 treatment. Participants must have measurable disease, be in good physical condition (ECOG 0 or 1), agree to use contraception, and not have other active cancers or severe health conditions.Check my eligibility
What is being tested?
The study tests lenvatinib combined with pembrolizumab against standard chemotherapy, and also lenvatinib alone. It aims to see if the combination is more effective based on tumor response rates. Patients are randomly assigned to these treatments.See study design
What are the potential side effects?
Possible side effects include high blood pressure from lenvatinib; immune-related reactions, fatigue, skin issues from pembrolizumab; plus typical chemo side effects like nausea, hair loss, low blood counts leading to infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a male and will not donate sperm or will use birth control.
Select...
I have Hepatitis B but am on antiviral therapy with an undetectable viral load.
Select...
My cancer has worsened despite treatments with platinum drugs and PD-1/PD-L1 inhibitors.
Select...
My head or neck cancer has returned or spread and cannot be cured with surgery or radiation.
Select...
I am fully active or can carry out light work.
Select...
My blood pressure is under control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4 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)
Secondary outcome measures
Duration of Response (DOR)
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
Number of Participants Who Experienced One or More Adverse Events (AEs)
+2 moreSide effects data
From 2019 Phase 3 trial • 392 Patients • NCT0132155470%
Hypertension
70%
Diarrhoea
60%
Weight decreased
43%
Fatigue
43%
Stomatitis
40%
Arthralgia
40%
Proteinuria
40%
Nausea
37%
Decreased appetite
33%
Headache
33%
Asthenia
33%
Dysphonia
30%
Myalgia
30%
Palmar-plantar erythrodysaesthesia syndrome
30%
Abdominal pain upper
30%
Vomiting
27%
Cough
27%
Abdominal pain
27%
Dizziness
23%
Pain in extremity
20%
Alopecia
20%
Back pain
20%
Rash
20%
Dysgeusia
20%
Nasopharyngitis
17%
Constipation
17%
Muscle spasms
17%
Dyspnoea
17%
Epistaxis
17%
Platelet count decreased
17%
Pyrexia
13%
Hypotension
13%
Oropharyngeal pain
13%
Musculoskeletal pain
10%
Anaemia
10%
Paraesthesia
10%
Flank pain
10%
Dyspepsia
10%
Dysphagia
10%
Sinusitis
10%
Oedema peripheral
10%
Pelvic pain
10%
Urinary tract infection
10%
Hypocalcaemia
10%
Musculoskeletal chest pain
10%
Haemoptysis
10%
Depression
10%
Upper respiratory tract infection
10%
Insomnia
7%
Skin fissures
7%
Vitamin D deficiency
7%
Ejection fraction decreased
7%
Pneumonia
7%
Hypomagnesaemia
7%
Joint swelling
7%
Bronchitis
7%
Blood cholesterol increased
7%
Dyspnoea exertional
7%
Hyperhidrosis
7%
Toothache
7%
Hyperaesthesia
7%
Sciatica
7%
Gastrooesophageal reflux disease
7%
Lung infection
7%
Dermatitis acneiform
7%
Hypothyroidism
7%
Alanine aminotransferase increased
7%
Dry skin
7%
Flatulence
7%
Productive cough
7%
Non-cardiac chest pain
7%
Abdominal distension
7%
Gingival pain
7%
Gastrointestinal infection
7%
Pain
7%
Lipase increased
3%
Blood calcium increased
3%
Electrocardiogram T wave inversion
3%
Hypoalbuminaemia
3%
Dementia
3%
Varicose vein
3%
Thermal burn
3%
Blood creatinine increased
3%
Electrocardiogram QT prolonged
3%
Post procedural haemorrhage
3%
Pathological fracture
3%
Syncope
3%
Cerebrovascular accident
3%
Phlebitis infective
3%
Haemorrhoids
3%
Cholecystitis acute
3%
Gastroenteritis
3%
Delirium
3%
General physical health deterioration
3%
Dry mouth
3%
Hyponatraemia
3%
Dehydration
3%
Coronary artery occlusion
3%
Lymph gland infection
3%
Metastatic pain
3%
Transient ischaemic attack
3%
Hydrocholecystis
3%
Vasculitis
3%
Hyperglycaemia
3%
Neck pain
3%
Thrombocytopenia
3%
Malaise
100%
80%
60%
40%
20%
0%
Study treatment Arm
OOL, Treatment Period: Lenvatinib 20 mg
Randomization Phase: Lenvatinib 24 mg
Randomization Phase: Placebo
OOL, Treatment Period: Lenvatinib 24 mg
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Lenvatinib + PembrolizumabExperimental Treatment2 Interventions
Participants will be treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met. Participants may receive up to an additional 17 cycles of pembrolizumab as Second Course treatment, with or without lenvatinib.
Group II: Lenvatinib MonotherapyActive Control1 Intervention
Participants will be treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met.
Group III: SOC ChemotherapyActive Control4 Interventions
Participants will be treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Lenvatinib
2005
Completed Phase 4
~2690
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,206 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,060,742 Total Patients Enrolled
Eisai Inc.Industry Sponsor
516 Previous Clinical Trials
158,636 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have undergone 4 or more treatments for my recurring or spreading cancer.I am a male and will not donate sperm or will use birth control.I have received an organ or tissue transplant from another person.My condition can be treated with the aim of curing it.I am currently on medication for an infection.I have an immune system disorder or recently received treatment that weakens my immune system.I have active brain metastases or carcinomatous meningitis.I have active tuberculosis.I have recently undergone chemotherapy, targeted therapy, or radiation.I have a severe abnormal connection between my organs.I have had serious heart problems in the last year.I have Hepatitis B but am on antiviral therapy with an undetectable viral load.I have been diagnosed with HIV.My cancer has worsened despite treatments with platinum drugs and PD-1/PD-L1 inhibitors.I have not had major surgery in the last 3 weeks.My organs are functioning well.My head or neck cancer has returned or spread and cannot be cured with surgery or radiation.I have not had any other cancer progress in the last 3 years.I have been treated with lenvatinib before.My doctor expects I have less than 3 months to live or my disease is getting worse quickly.I have trouble swallowing pills.I have not received a live vaccine in the last 30 days.I am fully active or can carry out light work.I have or had lung inflammation that needed steroids.I have a condition that affects how my body absorbs medication taken by mouth.My blood pressure is under control.
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.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Lenvatinib + Pembrolizumab
- Group 2: Lenvatinib Monotherapy
- Group 3: SOC Chemotherapy
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open vacancies for participants in this research endeavor?
"Yes, reliable information from clinicaltrials.gov shows that the trial is currently recruiting participants who meet specific criteria. It was first published on August 6th 2020 and recently modified on November 10th 2022."
Answered by AI
At what facilities is this medical research taking place?
"Currently, 37 medical sites are conducting patient recruitment for this trial. Those within Weston, Mineola and Boston can access the treatment more easily than other locations across the country. Therefore, it is advisable to select a clinic closeby in order to reduce travel requirements when participating in the study."
Answered by AI
How many patients are invited to take part in this clinical research?
"This trial necessitates the enrolment of 400 compliant individuals. Potential participants may range to different locations, including Cleveland Clinic Florida in Weston, FL and The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C in Mineola, NY."
Answered by AI
In what ways is Lenvatinib generally employed medicinally?
"Patients suffering from cancer, Hodgkin's Disease and other ailments may be prescribed Lenvatinib to assist in their pharmacotherapy."
Answered by AI
What are the safety risks associated with Lenvatinib utilization?
"According to our assessment, Lenvatinib's safety is rated a 2 as it has only been through Phase 2 of clinical trials and while there is data supporting its security profile, none exists which verifies efficacy."
Answered by AI
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