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Tyrosine Kinase Inhibitor

Axitinib + Ipilimumab for Advanced Melanoma

Phase 2

Recruiting

Led By Zeynep Eroglu, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Prior treatment-related toxicity resolved to ≤ Grade 2 or baseline

No limit to prior lines of treatment but prior ipilimumab not permitted

Must not have

Patients with severe/unstable angina or symptomatic congestive heart failure within last 6 months are excluded

Patients with cerebrovascular accident, transient ischemic attack within last 6 months are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether combining two drugs can better treat advanced melanoma than either drug alone.

Who is the study for?

This trial is for adults with advanced melanoma, excluding uveal melanoma. Participants can have had any number of prior treatments but not ipilimumab. They must be at least 2 weeks out from major surgery and recovered from previous treatment side effects to Grade 2 or baseline. Those with treated brain metastases are eligible unless they're unstable or need steroids. No active autoimmune diseases requiring therapy, except replacement therapy like corticosteroids, are allowed.

What is being tested?

The study is testing the effectiveness of combining axitinib with ipilimumab in treating advanced melanoma. It's looking for people who haven't responded well to anti-PD-1/PD-L1 inhibitors or relapsed soon after treatment. Patients will receive both drugs and their response will be measured using specific criteria for tumor size changes over time.

What are the potential side effects?

Possible side effects include high blood pressure (which needs to be controlled before joining), bleeding issues, heart problems like severe angina or congestive heart failure within the past six months, stroke risks, and interactions with certain other medications that affect liver enzymes.

Eligibility Criteria

Inclusion Criteria

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

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My side effects from previous treatments are mild or gone.

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I have had treatments before, but never ipilimumab.

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I have HIV with undetectable viral load or cured hepatitis C.

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I am not on strong medication for an autoimmune disease, but I may be taking basic replacement therapy.

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My blood pressure is below 150/100.

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I have advanced melanoma that cannot be surgically removed, but it's not uveal melanoma.

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I can take care of myself and am up and about more than half of my waking hours.

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I can have a biopsy before and during treatment.

Exclusion Criteria

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

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I have not had severe heart problems or heart failure in the last 6 months.

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I have not had a stroke or mini-stroke in the last 6 months.

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I am not using, nor do I plan to use, strong CYP3A4/5 inhibitors or inducers.

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I do not have severe liver cirrhosis.

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I have not had severe bleeding in the last month.

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

Study Objectives

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

Primary study objectives

Overall Response Rate

Secondary study objectives

Clinical Benefit Rate

Duration of Response

Overall Survival

+1 more

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

1Treatment groups

Experimental Treatment

Group I: Ipilimumab + AxtinibExperimental Treatment2 Interventions

Participants will receive treatment with ipilimumab 3 mg/kg IV q3 weeks x 4 doses and axitinib at 5 mg by mouth twice daily. Each cycle is 3 weeks/21 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2014

Completed Phase 3

~3140

Axitinib

2020

Completed Phase 2

~3050