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Lenvatinib + Pembrolizumab for Skin Cancer

Phase 2

Waitlist Available

Led By Andrew Brohl, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

History of (non-infectious) pneumonitis that required steroids or has current pneumonitis

Known active CNS metastases and/or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment combining two drugs.

Who is the study for?

Adults diagnosed with Merkel cell carcinoma, stages II-IV, who can provide a tumor sample and are able to monitor their blood pressure at home. They must not be pregnant or breastfeeding and agree to use contraception. Excluded are those with active autoimmune diseases, certain infections like HIV or hepatitis, severe allergies to trial drugs, recent other cancer treatments or vaccinations, uncontrolled high blood pressure, or any condition that could affect study results.

What is being tested?

The trial is testing the combination of two drugs: Lenvatinib (oral) and Pembrolizumab (injection), in patients with Merkel cell carcinoma. It's a single-arm study where all participants receive the same treatment regimen before surgery to remove detectable cancer.

What are the potential side effects?

Possible side effects include high blood pressure; fatigue; nausea; kidney problems; liver issues; heart complications such as irregular heartbeat; increased risk of infection due to immune system effects; rash or skin reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have provided a sample of my tumor that has not been treated with radiation.

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

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I am 18 or older with a confirmed diagnosis of Merkel cell carcinoma.

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I am not pregnant, not breastfeeding, and follow the contraceptive guidelines.

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My cancer is at stage II, III, or IV according to the AJCC 8th edition.

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My disease can be completely removed with surgery.

Exclusion Criteria

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

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I have had pneumonitis treated with steroids or currently have it.

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I have active brain metastases or cancer in the lining of my brain.

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I am currently on medication for an infection.

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I have previously received therapy targeting my immune system.

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I have been diagnosed with HIV.

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I have a bleeding or clotting disorder, or I'm at high risk for severe bleeding.

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I have serious heart problems or a history of heart events.

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I have a history of Hepatitis B or an active Hepatitis C infection.

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

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I have been treated with a drug targeting blood vessel growth in cancer.

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My blood pressure is high despite taking medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathological Complete Response

Secondary study objectives

Percentage of patients able to complete both neoadjuvant cycles of trial therapy and able to complete planned surgical resection.

Progression Free Survival

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

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 with Merkel cell carcinoma amenable to complete resection will receive two cycles (6 weeks) of therapy with the combination of lenvatinib plus pembrolizumab and then proceed to planned resection within 2-4 weeks following completion of cycle 2. Following surgical recovery and completion of adjuvant radiation therapy (if indicated), treatment will resume with pembrolizumab monotherapy with intent to complete 17 cycles total of pembrolizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 17Eligibility criteria met