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Tyrosine Kinase Inhibitor

Axitinib + Nivolumab for Kidney Cancer

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 4 years

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 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Incidence of adverse events (AEs)

Overall response rate (ORR)

Overall survival

Other study objectives

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

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

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

Part A Cohort 1d: Arm N3+RT

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

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

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

2015

Completed Phase 3

~4010