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Tyrosine Kinase Inhibitor

Cabozantinib + Cetuximab for Head and Neck Cancer

Phase 1

Waitlist Available

Led By Loren Michel, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Capability of understanding and complying with the protocol requirements and signed the informed consent document

Age ≥ 18 years old

Must not have

Received >70 Gy of XRT to the neck in the same radiation field or head and neck radiation within 2 months prior to initiation

Concomitant anticoagulation with specified agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety of cabozantinib combined with cetuximab to treat HNSCC.

Who is the study for?

Adults with incurable head and neck squamous cell carcinoma, who have measurable disease and are in good physical condition (ECOG 0 or 1). They must not be pregnant, have had certain treatments recently, or have serious health issues that could interfere with the trial. Participants should agree to use contraception during the study.

What is being tested?

The trial is testing different doses of cabozantinib combined with cetuximab to see how safe they are for treating recurrent or metastatic head and neck cancer. The effects on patients at these varying doses will be closely monitored.

What are the potential side effects?

Potential side effects may include allergic reactions to medication components, bleeding issues including GI bleeding or coughing up blood, problems swallowing tablets, significant fatigue due to anemia or other blood disorders.

Eligibility Criteria

Inclusion Criteria

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

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I understand the study requirements and have signed the consent form.

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I am 18 years old or older.

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My blood tests and organ functions are within normal ranges.

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I am not pregnant and can become pregnant.

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I am fully active or can carry out light work.

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My cancer has spread or returned and cannot be removed by surgery.

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My cancer is a type of squamous cell carcinoma located in the head or neck.

Exclusion Criteria

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

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I have received more than 70 Gy of radiation to my neck or head in the last 2 months.

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I am currently taking blood thinners.

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My tumor is growing into or around major blood vessels.

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I have symptoms of an underactive thyroid.

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I need ongoing treatment with strong CYP3A4 inducers.

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My liver function is significantly impaired.

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I do not have any severe, uncontrolled illnesses.

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I have a serious wound, ulcer, or bone fracture that isn't healing.

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I have not had radiation therapy recently.

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I have been treated with cabozantinib before.

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I cannot swallow whole pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

maximum tolerated dose (MTD)

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT02101736

95%

HYPOTHYROIDISM

73%

DIARRHEA

55%

WEIGHT LOSS

50%

FATIGUE

41%

ALANINE AMINOTRANSFERASE INCREASED

41%

Neutrophil Count Decreased

41%

ASPARTATE AMINOTRANSFERASE INCREASED

41%

VOMITING

41%

ANOREXIA

41%

NAUSEA

36%

HYPERTENSION

36%

HEADACHE

36%

PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME

36%

PAIN IN EXTREMITY

32%

PROTEINURIA

32%

PAIN

27%

White Blood Cell Count Decreased

27%

ABDOMINAL PAIN

23%

PLATELET COUNT DECREASE

23%

HYPONATREMIA

23%

Decreased Platelet Count

23%

Platelet Count Decreased

23%

Renal & Urinary Disorders - Other, Ketonuria

23%

Skin Hypopigmentation

23%

HAIR COLOR CHANGE

18%

Upper Respiratory Infection

18%

HEMOGLOBIN INCREASED

18%

HYPOKALEMIA

18%

HYPOPHOSPHATEMIA

18%

Alopecia

18%

Hyperkalemia

14%

HYPERGLYCEMIA

14%

Pruritis

14%

HYPOGLYCEMIA

14%

Rash Acneiform

14%

Rash Maculopapular

14%

BILIRUBIN INCREASED

14%

ACNEIFORM RASH

14%

Cough

14%

Blood Bilirubin Increased

14%

DIZZINESS

14%

Skin And Subcutaneous Disorders - Other, Achromotricia

14%

CONSTIPATION

14%

Fever

NASAL CONGESTION

TUMOR PAIN

Papulopustular Rash

ALKALINE PHOSPHATASE INCREASED

Creatinine Increased

Back Pain

ABSOLUTE NEUTROPHIL COUNT DECREASED

LIPASE INCREASED

Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified

Paresthesia

ORAL PAIN

LYMPHOCYTE COUNT DECREASED

WEIGHT GAIN

HYPOCALCEMIA

DRY SKIN

Hypotension

Joint Range Of Motion Decreased

Hypertension

SERUM AMYLASE INCREASED

Investigations - Other, Eosinophilia

ANXIETY

Hypermagnesemia

Rash Ezcematoid

Behaviour Disturbance

Scalp Pain

Psychiatric Disorders - Other, Mood Swings

Sinus Tachycardia

Periodontal Disease

Myalgia

Tooth Infection

URINARY FREQUENCY

Conjunctivitis

Sinusitis

Syncope

Activated Partial Thromboplastin Time Prolonged

Breast Pain

Peripheral Motor Neuropathy

Scalp Lesion

Sore Throat

Tachycardia

JOINT RANGE OF MOTION DECREASED

INSOMNIA

Skin And Subcutaneous Disorders - Other, Dry Skin Patches

URINARY URGENCY

Allergic Rhinitis

Injury, Poisoning And Procedural Complications - Other, Ankle Injury

Peripheral Sensory Neuropathy

Injury, Poisoning And Procedural Complications- Other, Scalp Laceration

Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis

Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change

Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)

HEMATURIA

RASH

Gastrointestinal Disorders - Other, Buccal Cyst

Investigations - Other, International Normalized Ration Increased

Infections And Infestations - Other, Gi Viral Infection

Gastrointestinal Disorders - Other, Dental Pain

Stomach Pain

SKIN INFECTION

HYPOMAGNESEMIA

Muscle Weakness Upper Limb

Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger

Skin And Subcutaneous Tissue Disorders- Other, Erythema

Neuropathy

Infections And Infestations - Other, Covid-19

Investigations - Other, Increased Mean Corpuscular Volume

DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS

Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles

Surgical & Medical Procedures - Other, Dental Extractions

TENDONITIS

SINUS BRADYCARDIA

HYPERTHYROIDISM

Creatine Phosphokinase Increased

SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE

Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips

Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema

Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps

Muscle Weakness Lower Limb

Urine Discoloration

SPINAL CORD COMPRESSION

ANEMIA

PARONYCHIA

BRUISING

HYPOALBUMINEMIA

Ear And Labyrinth Disorders - Other, Impacted Cerumen

Ear Pain

Elevated Amylase

Facial Pain

Gastrointestinal Disorders - Other, Stomatitis

Hoarseness

Laryngitis

Leg Pain

Localized Edema

Lung Infection

Metabolism And Nutrition Disorders - Other, Decreased Oral Intake

Metabolism Other - Decreased Vitamin D

Metbolism And Nutrition Disorders - Other, Hyperchloremia

Mucositis Oral

100%

80%

60%

40%

20%

Study treatment Arm

Cohort B

Cohort A

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: Cabozantinib in Combination With CetuximabExperimental Treatment2 Interventions

Cetuximab will be administered at 500 mg/m\^2 intravenously every other week. Cabozantinib will be initiated at 40 mg PO daily, with subsequent 20 mg or 40 mg doses as tolerated per the study design.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

Cabozantinib

2020

Completed Phase 2

~2360