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Tyrosine Kinase Inhibitor

Cabozantinib for Kidney Cancer

Phase 2
Recruiting
Led By Matthew Zibelman, MD
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years
ECOG performance status 0 - 2
Must not have
Active, symptomatic brain metastases or leptomeningeal metastases
Current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4 inhibitors and inducers
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial is testing a new drug for kidney cancer patients who have not previously been treated with it.

Who is the study for?
Adults over 18 with advanced kidney cancer, either untreated or not previously treated with Cabozantinib. They must be in fairly good health, understand the study and consent to it, agree to use contraception, and have at least one measurable tumor. Excluded are those with uncontrolled illnesses, certain heart conditions, other active cancers needing treatment, significant bleeding history or major surgery recently.
What is being tested?
The trial is testing a different dosing schedule of Cabozantinib for patients with metastatic renal cell carcinoma (mRCC). It's open to all-risk frontline mRCC patients or any line mRCC patients who haven't tried Cabozantinib before.
What are the potential side effects?
Cabozantinib may cause high blood pressure, tiredness, loss of appetite, nausea/vomiting/diarrhea; hand-foot skin reactions; weight loss; changes in hair color; taste changes; new/worsening high blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have active brain or spinal cord cancer symptoms.
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I am not using, nor do I need, drugs or foods that strongly affect drug metabolism.
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I have not had major or minor surgery recently.
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I haven't had significant bleeding in the last 3 months.
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I am currently taking blood thinners.
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I have severe liver problems.
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I am HIV-positive and on antiretroviral therapy.
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I do not have any severe illnesses or mental health issues that would stop me from following the study's requirements.
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I have lung lesions or disease in my airways.
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My cancer is growing into or around major blood vessels.
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I have been treated with cabozantinib before.

Timeline

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
Cohort A: To show that alternative cabozantinib dosing can improve average daily dose compared to historical controls
Cohort B: To show that alternative cabozantinib dosing + nivolumab (standard dose) can improve 12-month rate of progression-free survival over standard dose cabozantinib + nivolumab
Secondary study objectives
Cohort A: Decreased grade ≥ 3 adverse events compared to historical controls (METEOR trial)
Cohort A: Improved median duration of time on drug compared to historical controls
Cohort A: Objective response rate per RECIST 1.1 criteria of all patients treated
+5 more

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%
NAUSEA
41%
ANOREXIA
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PROTEINURIA
32%
PAIN
27%
White Blood Cell Count Decreased
27%
ABDOMINAL PAIN
23%
Skin Hypopigmentation
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
Platelet Count Decreased
23%
Decreased Platelet Count
23%
HAIR COLOR CHANGE
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
18%
HYPOKALEMIA
18%
HYPOPHOSPHATEMIA
18%
Alopecia
18%
Hyperkalemia
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
14%
Pruritis
14%
HYPERGLYCEMIA
14%
BILIRUBIN INCREASED
14%
DIZZINESS
14%
ACNEIFORM RASH
14%
Cough
14%
Blood Bilirubin Increased
14%
CONSTIPATION
14%
HYPOGLYCEMIA
14%
Rash Acneiform
14%
Rash Maculopapular
14%
Fever
9%
Papulopustular Rash
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ALKALINE PHOSPHATASE INCREASED
9%
Back Pain
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
LIPASE INCREASED
9%
Creatinine Increased
9%
Paresthesia
9%
ORAL PAIN
9%
LYMPHOCYTE COUNT DECREASED
9%
TUMOR PAIN
9%
NASAL CONGESTION
9%
WEIGHT GAIN
9%
HYPOCALCEMIA
9%
DRY SKIN
5%
Muscle Weakness Lower Limb
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
Sore Throat
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Hypertension
5%
SERUM AMYLASE INCREASED
5%
Behaviour Disturbance
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Investigations - Other, Eosinophilia
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Rash Ezcematoid
5%
HYPOMAGNESEMIA
5%
Activated Partial Thromboplastin Time Prolonged
5%
Investigations - Other, International Normalized Ration Increased
5%
Myalgia
5%
Scalp Pain
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
Hypermagnesemia
5%
Hypotension
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Psychiatric Disorders - Other, Mood Swings
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
TENDONITIS
5%
INSOMNIA
5%
URINARY URGENCY
5%
Allergic Rhinitis
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Sinus Tachycardia
5%
Periodontal Disease
5%
Peripheral Sensory Neuropathy
5%
Scalp Lesion
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Tachycardia
5%
Infections And Infestations - Other, Covid-19
5%
Peripheral Motor Neuropathy
5%
Tooth Infection
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
ANXIETY
5%
JOINT RANGE OF MOTION DECREASED
5%
URINARY FREQUENCY
5%
Conjunctivitis
5%
Muscle Weakness Upper Limb
5%
Neuropathy
5%
Sinusitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Stomach Pain
5%
Syncope
5%
RASH
5%
HEMATURIA
5%
Breast Pain
5%
Joint Range Of Motion Decreased
5%
SINUS BRADYCARDIA
5%
HYPERTHYROIDISM
5%
Creatine Phosphokinase Increased
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
SKIN INFECTION
5%
Urine Discoloration
5%
SPINAL CORD COMPRESSION
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
HYPOALBUMINEMIA
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Facial Pain
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Hoarseness
5%
Laryngitis
5%
Leg Pain
5%
Localized Edema
5%
Lung Infection
5%
Metabolism And Nutrition Disorders - Other, Decreased Oral Intake
5%
Metabolism Other - Decreased Vitamin D
5%
Metbolism And Nutrition Disorders - Other, Hyperchloremia
5%
Mucositis Oral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cabozantinib and nivolumabExperimental Treatment2 Interventions
Cabozantinib treatment will receive monthly fix-dosed nivolumab infusions, and start at 40 mg of cabozantinib daily and dose escalate or de-escalate based on pre-specified criteria and at set dosing schedules to allow for smaller median dose changes between adjustments. The de-escalation would be fine-tuned and adjustments would be made in 10 mg average daily dosing increments by utilizing alternate day dosing schedules (e.g 60 mg/40 mg every other day) rather than decreasing by 20 mg. The maximum dose of cabozantinib is 60 mg daily. Cycles would be 28 days, with weekly follow-up for cycle 1 and bi-weekly follow-up for cycle 2 to allow for prompt dose adjustments, and then monthly. At each check-in, patients that have met established protocol criteria and were not yet at the maximum dose of 60 mg daily would be eligible for dose-escalation. Patients would also be dose de-escalated as determined by the investigator. Patients who de-escalate may be allowed to re-escalate in the future.
Group II: CabozantinibExperimental Treatment1 Intervention
Cabozantinib treatment will start at 40 mg of cabozantinib daily and dose escalate or de-escalate based on pre-specified criteria and at set dosing schedules to allow for smaller median dose changes between adjustments. The de-escalation would be fine-tuned and adjustments would be made in 10 mg average daily dosing increments by utilizing alternate day dosing schedules (e.g 60 mg/40 mg every other day) rather than decreasing by 20 mg. The maximum dose of cabozantinib is 60 mg daily. Cycles would be 28 days, with weekly follow-up for cycle 1 and bi-weekly follow-up for cycle 2 to allow for prompt dose adjustments, and then monthly. At each check-in, patients that have met the established protocol criteria and were not yet at the maximum dose of 60 mg daily would be eligible for dose-escalation. Patients would also be dose de-escalated as determined by the investigator. Patients who de-escalate may be allowed to re-escalate in the future.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved
Nivolumab
2014
Completed Phase 3
~5220

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
233 Previous Clinical Trials
38,825 Total Patients Enrolled
ExelixisIndustry Sponsor
119 Previous Clinical Trials
19,833 Total Patients Enrolled
Matthew Zibelman, MDPrincipal InvestigatorFox Chase Cancer Center
1 Previous Clinical Trials
26 Total Patients Enrolled

Media Library

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05263050 — Phase 2
Renal Cell Carcinoma Research Study Groups: Cabozantinib, Cabozantinib and nivolumab
Renal Cell Carcinoma Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT05263050 — Phase 2
Cabozantinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05263050 — Phase 2
~29 spots leftby Feb 2026
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