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Tyrosine Kinase Inhibitor

Pembrolizumab + Lenvatinib for Gastric Cancer

Phase < 1

Recruiting

Led By Mariela Blum

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

Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale within 5 days of starting study treatment

Male and female subjects who are at least 18 years of age with histologically and cytologically documented diagnosis as gastric or gastroesophageal adenocarcinoma

Must not have

Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Diagnosis of immunodeficiency or receiving systemic steroid therapy exceeding 10 mg daily of prednisone equivalent within 7 days prior to the first dose of trial treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing pembrolizumab and lenvatinib to see if they can shrink or slow the growth of gastroesophageal adenocarcinoma.

Who is the study for?

This trial is for adults with advanced or metastatic gastroesophageal adenocarcinoma that's inoperable and hasn't responded to standard treatments. Participants must have acceptable organ function, controlled blood pressure, no major surgery within 3 weeks before the trial, not be pregnant or breastfeeding, and agree to use effective contraception.

What is being tested?

The study tests pembrolizumab (an immunotherapy drug) combined with lenvatinib (a drug blocking enzymes needed by cancer cells). It aims to see if this combination can better attack the cancer and halt its growth compared to current methods.

What are the potential side effects?

Potential side effects include immune system reactions affecting organs, high blood pressure due to lenvatinib, fatigue from both drugs, liver enzyme changes from pembrolizumab, and possibly other common chemotherapy-related issues like nausea.

Eligibility Criteria

Inclusion Criteria

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

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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 stomach or gastroesophageal cancer.

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My kidney function is within the normal range.

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My advanced stomach or esophagus cancer cannot be surgically removed and standard treatments have not worked.

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I agree to follow the required contraception measures.

Exclusion Criteria

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

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I have cancer that has spread to my brain or surrounding membranes.

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I have an immune system disorder or have been taking more than 10 mg of steroids daily.

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I have a history of hepatitis B or C.

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I have another cancer that is getting worse or needs treatment.

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My heart's pumping ability is below the normal range.

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I have a severe fistula.

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I am allergic to pembrolizumab, lenvatinib, or their ingredients.

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I have received treatment with specific drugs before.

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I am currently on medication for an infection.

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I have not had major heart problems in the last year.

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My scans show my tumor is affecting major blood vessels or has holes.

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I have had a transplant of tissue, an organ, or bone marrow from another person.

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I have been diagnosed with HIV.

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

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I have a condition that affects how my body absorbs medication.

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I have fluid buildup in my abdomen or around my lungs causing symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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 and lenvatinib PO QD, Treatment repeats every 42 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity.

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