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Tyrosine Kinase Inhibitor

Lenvatinib + Pembrolizumab for Head and Neck Cancer

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
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
Must not have
Treated with 4 or more systemic regimens for recurrent/metastatic disease
History of allogeneic tissue/solid organ transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 7 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if lenvatinib combined with pembrolizumab or lenvatinib alone is better for patients with head and neck cancer that hasn't responded to other treatments. Lenvatinib stops cancer growth, and pembrolizumab boosts the immune system to fight cancer. Lenvatinib has shown better curative effects when combined with other treatments compared to its use as a single agent.

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.
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.
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 below
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I am a male and will not donate sperm or will use birth control.
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I have Hepatitis B but am on antiviral therapy with an undetectable viral load.
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My cancer has worsened despite treatments with platinum drugs and PD-1/PD-L1 inhibitors.
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My head or neck cancer has returned or spread and cannot be cured with surgery or radiation.
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I am fully active or can carry out light work.
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My blood pressure is under control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have undergone 4 or more treatments for my recurring or spreading cancer.
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I have received an organ or tissue transplant from another person.
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My condition can be treated with the aim of curing it.
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I am currently on medication for an infection.
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I have an immune system disorder or recently received treatment that weakens my immune system.
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I have active brain metastases or carcinomatous meningitis.
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I have active tuberculosis.
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I have a severe abnormal connection between my organs.
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I have been diagnosed with HIV.
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I have not had major surgery in the last 3 weeks.
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I have been treated with lenvatinib before.
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My doctor expects I have less than 3 months to live or my disease is getting worse quickly.
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I have trouble swallowing pills.
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I have or had lung inflammation that needed steroids.
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I have a condition that affects how my body absorbs medication taken by mouth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival (OS)
Secondary study objectives
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 more

Side effects data

From 2019 Phase 3 trial • 392 Patients • NCT01321554
70%
Diarrhoea
69%
Hypertension
57%
Decreased appetite
54%
Weight decreased
49%
Nausea
44%
Fatigue
40%
Headache
38%
Proteinuria
38%
Vomiting
38%
Stomatitis
33%
Palmar-plantar erythrodysaesthesia syndrome
33%
Arthralgia
33%
Dysphonia
32%
Constipation
30%
Cough
26%
Asthenia
25%
Oedema peripheral
21%
Rash
20%
Back pain
20%
Myalgia
19%
Abdominal pain
18%
Dysgeusia
18%
Pain in extremity
18%
Abdominal pain upper
18%
Musculoskeletal pain
18%
Dry mouth
18%
Dyspnoea
17%
Dizziness
16%
Pyrexia
16%
Oropharyngeal pain
16%
Hypokalaemia
15%
Dyspepsia
15%
Hypocalcaemia
14%
Epistaxis
13%
Dysphagia
13%
Alopecia
12%
Anaemia
12%
Musculoskeletal chest pain
12%
Dry skin
11%
Urinary tract infection
11%
Nasopharyngitis
10%
Oral pain
10%
Thrombocytopenia
10%
Hypoalbuminaemia
10%
Blood creatinine increased
10%
Electrocardiogram QT prolonged
10%
Upper respiratory tract infection
9%
Dehydration
9%
Neck pain
8%
Depression
8%
Hypomagnesaemia
8%
Influenza like illness
8%
Muscle spasms
8%
Lymphopenia
8%
Alanine aminotransferase increased
8%
Muscular weakness
7%
Malaise
7%
Haematuria
7%
Ejection fraction decreased
7%
Pruritus
7%
Hyponatraemia
7%
Blood thyroid stimulating hormone increased
7%
Platelet count decreased
7%
Aspartate aminotransferase increased
7%
Toothache
7%
Glossodynia
7%
Blood alkaline phosphatase increased
7%
Hyperkeratosis
7%
Bronchitis
6%
Influenza
6%
Flatulence
6%
Dysuria
6%
Anxiety
6%
Hyperglycaemia
6%
Leukopenia
5%
Non-cardiac chest pain
5%
Productive cough
5%
Paraesthesia
5%
Hypothyroidism
5%
Haemoptysis
5%
White blood cell count decreased
5%
Pneumonia
3%
General physical health deterioration
2%
Sepsis
2%
Cholecystitis
2%
Pulmonary embolism
2%
Malignant pleural effusion
2%
seizure
2%
Acute myocardial infarction
2%
Atrial fibrillation
2%
Lower respiratory tract infection
2%
Hypotension
2%
Lung infection
2%
Spinal cord compression
2%
Acute kidney injury
1%
Blood uric acid increased
1%
Respiratory failure
1%
Monoparesis
1%
Hypercalcaemia
1%
Hepatic failure
1%
Appendicitis
1%
Death
1%
Acute respiratory failure
1%
Osteoarthritis
1%
Intestinal obstruction
1%
Small intestinal obstruction
1%
Intracranial tumour haemorrhage
1%
Acute coronary syndrome
1%
Colitis
1%
Transient ischaemic attack
1%
Pancreatitis
1%
Atrial flutter
1%
Cardio-respiratory arrest
1%
Uterine prolapse
1%
Coronary artery stenosis
1%
Pneumatosis intestinalis
1%
Cerebrovascular accident
1%
Confusional state
1%
Liver injury
1%
Diverticulitis
1%
Bacteraemia
1%
Gastroenteritis
1%
Perineal abscess
1%
Wound infection
1%
Malignant neoplasm progression
1%
Bone pain
1%
Cancer pain
1%
Syncope
1%
Vocal cord paralysis
1%
Nephrotic syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomization Phase: Lenvatinib 24 mg
Randomization Phase: Placebo
OOL, Treatment Period: Lenvatinib 24 mg
OOL, Treatment Period: Lenvatinib 20 mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~2810
Lenvatinib
2017
Completed Phase 4
~2040

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Oral Squamous Cell Carcinoma (OSCC) include targeted therapies and immunotherapies. Lenvatinib, a multi-kinase inhibitor, targets receptors such as VEGFR, FGFR, PDGFR, RET, and KIT, which are involved in tumor growth and angiogenesis. Pembrolizumab, an anti-PD-1 monoclonal antibody, enhances the immune system's ability to detect and fight tumor cells by blocking the PD-1 pathway, which tumors use to evade immune detection. These mechanisms are important for OSCC patients as they can inhibit tumor growth and improve immune response, potentially leading to better clinical outcomes.
Combination of pembrolizumab and lenvatinib is a potential treatment option for heavily pretreated recurrent and metastatic head and neck cancer.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,088 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,000 Previous Clinical Trials
5,181,424 Total Patients Enrolled
Eisai Inc.Industry Sponsor
521 Previous Clinical Trials
159,457 Total Patients Enrolled

Media Library

Lenvatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04428151 — Phase 2
Lenvatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04428151 — Phase 2
Squamous Cell Carcinoma Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT04428151 — Phase 2
Squamous Cell Carcinoma Research Study Groups: Lenvatinib + Pembrolizumab, Lenvatinib Monotherapy, SOC Chemotherapy
~79 spots leftby Nov 2025