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Tyrosine Kinase Inhibitor

Axitinib + Nivolumab for Kidney Cancer

Louisville, KY

Phase 2

Waitlist Available

Led By James I Geller

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 3 x ULN for age (performed within 7 days prior to enrollment)

Patients must have a body surface area (BSA) >= 0.53 m^2

Must not have

Patients who have received prior therapy with more than one anti VEGF based agent (antibody or tyrosine kinase inhibitor)

Patients who previously received an allogeneic stem cell transplant (SCT) or solid organ transplant are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years from study entry

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a combination of two drugs, axitinib and nivolumab, to see how well they work in treating patients with a certain type of kidney cancer.

Who is the study for?

This trial is for patients with a specific kidney cancer called TFE/translocation renal cell carcinoma that can't be surgically removed or has spread. Participants must meet various health criteria, including proper organ function and blood counts, and not have received certain treatments recently. It's open to individuals as young as one year old who are expected to live at least 8 weeks.

What is being tested?

The study tests axitinib and nivolumab in treating unresectable or metastatic tRCC. Axitinib blocks enzymes needed for tumor growth, while nivolumab, an immunotherapy drug, helps the immune system attack cancer cells. The goal is to see if this combination works better than standard treatments.

What are the potential side effects?

Possible side effects include high blood pressure from axitinib and immune-related reactions from nivolumab such as inflammation of organs or skin problems. Both drugs may also cause fatigue, liver issues, digestive disturbances, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My liver function tests are within normal limits.

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My body surface area is at least 0.53 square meters.

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It has been over a week since my last biologic treatment.

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My recent blood tests show normal bilirubin levels.

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I have never had a heart attack or severe heart-related issues.

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My cancer can be measured by scans or tests.

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My tumor has specific characteristics and has been tested for TFE3 protein or gene changes.

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My kidney function is within the normal range for my age.

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My platelet count is at least 75,000 and I haven't needed a transfusion.

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My kidney function is within the required range for the study.

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My heart's QT interval is less than 480 msec, and if it's between 450-480 msec, causes have been addressed.

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My blood pressure is within the normal range for my age, height, and gender.

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I have waited the required time after my radiation therapy before joining this trial.

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I am at least 12 months old.

Exclusion Criteria

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

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I have been treated with more than one anti-VEGF medication.

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I have not had a stem cell or solid organ transplant.

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I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks.

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I haven't had major surgery or serious injuries in the last 7 days and don't plan major surgery within 12 weeks.

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I cannot swallow whole tablets.

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I have previously been treated with axitinib, nivolumab, or other PD1/PD-L1 inhibitors.

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I am not allergic to axitinib, nivolumab, or their ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years from study entry

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years from study entry

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from study entry for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression free survival (PFS)

Secondary study objectives

Overall response rate (ORR)

Overall survival (OS)

Percentage of patients experiencing adverse events (AEs)

Other study objectives

Pharmacokinetics (PK) parameters of axitinib

Translocation morphology renal cell carcinoma clinical behavior

Type of antitumor immune response and stability of T cell activation

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

70%

Fatigue

50%

Headache

45%

Confusional state

45%

Cough

40%

Malignant neoplasm progression

35%

Hemiparesis

35%

Diarrhoea

30%

Gait disturbance

30%

Nausea

30%

Pruritus

25%

Urinary tract infection

25%

Fall

25%

Hyperglycaemia

25%

Muscular weakness

25%

Rash

20%

Constipation

20%

Vomiting

20%

Lethargy

20%

Memory impairment

20%

Urinary incontinence

20%

Dizziness

20%

Nasal congestion

15%

Abdominal pain

15%

Alanine aminotransferase increased

15%

Lymphocyte count decreased

15%

Platelet count decreased

15%

Decreased appetite

15%

Arthralgia

15%

Cognitive disorder

10%

Aspartate aminotransferase increased

10%

Oedema peripheral

10%

Facial paresis

10%

Pyrexia

10%

Candida infection

10%

Depressed level of consciousness

10%

Syncope

10%

Pulmonary embolism

10%

Anaemia

10%

Sinus tachycardia

10%

Anal incontinence

10%

Asthenia

10%

Tooth infection

10%

Upper respiratory tract infection

10%

Lipase increased

10%

Paraesthesia

10%

Psychomotor skills impaired

10%

Seizure

10%

Agitation

10%

Anxiety

10%

Disorientation

10%

Dehydration

10%

Hypoalbuminaemia

10%

Hypokalaemia

10%

Hyponatraemia

10%

Aphasia

10%

Dysarthria

10%

Dyspnoea

10%

Rash maculo-papular

Dysphagia

Dermatitis acneiform

Oedema

Pain

Cardio-respiratory arrest

Autoimmune thyroiditis

Pneumonia

Hip fracture

White blood cell count decreased

Enterocolitis infectious

Tumour flare

Brain oedema

Cerebrovascular accident

Ischaemic stroke

Mental status changes

Aspiration

Herpes zoster

Haemorrhage intracranial

Hypoxia

Pneumonitis

Respiratory distress

Atrial fibrillation

Cushingoid

Hyperthyroidism

Hypothyroidism

Dry eye

Eyelid ptosis

Visual field defect

Visual impairment

Dyspepsia

Oral candidiasis

Stomatitis

Chills

Amylase increased

Blood alkaline phosphatase increased

Blood bilirubin increased

Weight decreased

Weight increased

Tremor

Vasogenic cerebral oedema

Depression

Insomnia

Pollakiuria

Hypocalcaemia

Proteinuria

Back pain

Myalgia

Amnesia

Ataxia

Balance disorder

Dysphonia

Dry skin

Deep vein thrombosis

Hypertension

Hypotension

Colitis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1b: Arm N3+I1

Cohort 1: Arm N3

Cohort 1: Arm N1+I3

Cohort 2: Arm N3

Part A Cohort 1c: Arm N3+RT+TMZ

Cohort 2: Arm B

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Part A Cohort 1d: Arm N3+RT

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C (nivolumab)Experimental Treatment1 Intervention

Patients receive nivolumab IV over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (axitinib)Experimental Treatment1 Intervention

Patients receive axitinib PO BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AS OF 1/23/2020 - PROSPECTIVE PATIENTS ARE RANDOMLY ASSIGNED TO ARMS A OR C)

Group III: Arm A (axitinib, nivolumab)Experimental Treatment2 Interventions

Patients receive axitinib PO BID on days 1-28 and nivolumab intravenously (IV) over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axitinib

2020

Completed Phase 2

~3050

Nivolumab

2014

Completed Phase 3

~3880