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Tyrosine Kinase Inhibitor

Lenvatinib + Pembrolizumab for Advanced Thyroid Cancer

Phase 2

Recruiting

Led By Maria E Cabanillas

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients who are unwilling to undergo surgery or external beam radiation

Pathologic findings supporting the clinical impression of anaplastic thyroid carcinoma, including diagnoses consistent with anaplastic thyroid carcinoma, undifferentiated carcinoma, squamous carcinoma, carcinoma with spindled, giant cell, or epithelial features, poorly differentiated carcinoma with pleomorphism, extensive necrosis with tumor cells present

Must not have

Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment

Females who are breastfeeding or pregnant at Screening or Baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well lenvatinib and pembrolizumab work together to treat patients with anaplastic thyroid cancer that cannot be removed by surgery or has spread to other parts of the body.

Who is the study for?

This trial is for adults with advanced anaplastic thyroid cancer that's either spread to nearby areas and can't be surgically removed, or has metastasized. Participants need functioning major organs, no recent surgeries, controlled blood pressure without intense medication, and no severe heart issues. They must not have had chemotherapy within the last week or suffer from unmanaged autoimmune diseases. Pregnant or breastfeeding women are excluded.

What is being tested?

The study tests a combination of lenvatinib (which may halt tumor growth by blocking enzymes needed for cell growth) and pembrolizumab (an immunotherapy drug that might help the immune system fight cancer). The goal is to see if this combo works better than each drug alone in treating stage IVB/C anaplastic thyroid cancer.

What are the potential side effects?

Possible side effects include high blood pressure, fatigue, liver problems like increased enzymes, kidney issues reflected by changes in urine protein levels, bleeding risks especially if there's tumor invasion into major vessels, as well as potential allergic reactions to the drugs' components.

Eligibility Criteria

Inclusion Criteria

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

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I am not willing to have surgery or radiation treatment.

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My thyroid cancer diagnosis includes specific aggressive features.

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My cancer cannot be removed by surgery and has spread.

Exclusion Criteria

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

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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

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I am not pregnant or breastfeeding.

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I haven't had chemotherapy in the last week or still have side effects from it.

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My blood pressure is high despite taking medication.

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I have not received any anti-angiogenic treatments.

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

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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 brain metastases that have not been treated.

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I have not had major surgery within the last week.

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I do not have any open wounds or fistulas.

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I do not have serious heart problems like recent heart attacks or severe heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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

Tumor response

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: Treatment (pembrolizumab, lenvatinib)Experimental Treatment2 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenvatinib PO daily on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

Lenvatinib

2017

Completed Phase 4

~2070