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Tyrosine Kinase Inhibitor

Pembrolizumab +/− Lenvatinib for Head and Neck Cancer (LEAP-10 Trial)

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

Participants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status

Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1

Must not have

Has an active infection requiring systemic therapy. (e.g., tuberculosis, known viral or bacterial infections, etc.)

Has clinically significant cardiovascular impairment within 12 months of the first dose of study intervention, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident/transient ischemic attack (TIA)/stroke, cardiac revascularization, or cardiac arrhythmia associated with hemodynamic instability

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~ 37 months

Awards & highlights

Pivotal Trial

Summary

This trial is studying whether giving pembrolizumab with or without lenvatinib to people with cancer of the head and neck who have PD-L1 selection is better than giving pembrolizumab with placebo.

Who is the study for?

This trial is for adults with recurrent or metastatic head and neck squamous cell carcinoma that can't be cured by surgery or radiation. They must have good organ function, not be pregnant or breastfeeding, agree to use contraception, and have a certain level of physical ability (ECOG score 0-1). People who've had recent major surgery, live vaccines, other cancer treatments like pembrolizumab or similar drugs in the past are excluded.

What is being tested?

The study tests if combining Pembrolizumab with Lenvatinib improves response rates, slows disease progression, and extends survival compared to Pembrolizumab with a placebo. Participants will either receive both drugs or one drug plus a placebo without knowing which group they're in.

What are the potential side effects?

Pembrolizumab may cause immune system-related side effects such as inflammation of organs; skin reactions; liver issues; hormonal gland problems like thyroid disorders; and lung issues like pneumonitis. Lenvatinib might cause high blood pressure, fatigue, nausea, decreased appetite among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My oropharyngeal cancer has been tested for HPV.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My head or neck cancer is newly diagnosed and at stage IV.

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My cancer is in my throat, mouth, or voice box.

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My head or neck cancer cannot be cured with surgery or radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for an active infection.

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I haven't had major heart problems or strokes in the last year.

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I have been treated with specific immune therapy drugs before.

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I have not received a live vaccine within the last 30 days.

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I have cancer that has spread to my brain or spinal cord.

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I have received an organ or tissue transplant from another person.

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I have had or currently have lung inflammation treated with steroids.

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I have a history of hepatitis B or active hepatitis C.

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I am not allergic or severely sensitive to pembrolizumab or lenvatinib.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I have been treated with lenvatinib or pembrolizumab before.

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I have trouble swallowing pills or taking liquid medicine.

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My condition can be treated with the goal of curing it.

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I have a severe fistula.

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I have another cancer that is getting worse or was treated in the last 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~ 37 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~ 37 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~ 37 months for reporting.

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) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

Overall Survival (OS)

Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR).

Secondary study objectives

Duration of Response (DOR)

Percentage of Participants Who Discontinued Study Drug Due to an AE

Percentage of Participants Who Experienced an Adverse Event (AE)

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab with LenvatinibExperimental 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.

Group II: Pembrolizumab with PlaceboActive Control2 Interventions

Participants receive lenvatinib-matching placebo 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenvatinib

2017

Completed Phase 4

~2070

Pembrolizumab

2017

Completed Phase 3

~3150