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Tyrosine Kinase Inhibitor

Nivolumab + Axitinib for Advanced Melanoma

Phase 2

Waitlist Available

Led By Yana Najjar, MD

Research Sponsored by Yana Najjar

Eligibility Criteria Checklist

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

Must have

Have unresectable (stage III) or advanced (stage IV) cutaneous or mucosal melanoma. Patients with uveal melanoma are not eligible.

Have a performance status of 0 or 1 on the ECOG Performance Scale.

Must not have

Has Class III or IV heart failure based on the New York Heart Association.

Has a known history of HIV (HIV 1/2 antibodies) if the CD4 count is less than 350 mm3 or serum HIV viral load is < 25,000 IU/mL.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing a new combination therapy for melanoma that has progressed despite prior treatment. The new therapy consists of two drugs given intravenously and by mouth, respectively. Patients may continue on the therapy for up to two years if it is well tolerated and effective.

Who is the study for?

This trial is for adults with stage III or IV melanoma that worsened after anti-PD1 therapy, possibly with anti-CTLA4. They must have measurable disease, be able to perform daily activities (ECOG 0 or 1), and use birth control. Excluded are those with active TB, recent major surgery or radiation, certain heart conditions, uncontrolled hypertension, known allergies to the drugs tested, some prior severe side effects from similar treatments, and pregnant or breastfeeding individuals.

What is being tested?

The study tests a combination of nivolumab (an immunotherapy drug) given intravenously every four weeks and axitinib (a cancer growth blocker) taken orally twice daily. Participants can receive these medications for up to two years unless they experience significant disease progression or intolerable side effects.

What are the potential side effects?

Possible side effects include high blood pressure due to axitinib; fatigue; liver issues; immune system reactions like inflammation in organs; skin reactions; digestive problems such as diarrhea; increased risk of infections due to nivolumab.

Eligibility Criteria

Inclusion Criteria

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

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My melanoma cannot be removed by surgery and is not uveal melanoma.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I have severe heart failure.

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I have HIV with specific CD4 count and viral load levels.

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I have had a severe hypertension crisis or brain issues due to high blood pressure.

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I had side effects from previous cancer immunotherapy that haven't fully improved.

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I haven't had chemotherapy or targeted therapy in the last week and have recovered from previous treatments.

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I have never had myocarditis, Guillain-Barre syndrome, encephalitis, meningitis, transverse myelitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis.

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I have received radiation therapy within the last 2 weeks.

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I have had severe side effects from previous immune treatments that made me stop the treatment.

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I am not using or planning to use strong CYP3A4/5 inhibitors or eat grapefruit.

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I am currently on IV antibiotics for an infection.

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I am not using or planning to use strong CYP3A4/5 inducers like carbamazepine or St. John's wort.

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I have an active tuberculosis infection.

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I have not had major surgery in the last 4 weeks.

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I have not received a live vaccine in the last 30 days.

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I have had pneumonitis treated with steroids or have it now.

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I have not had a major clotting or bleeding event in the last 6 months.

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 (ORR)

Secondary study objectives

Overall Survival (OS)

Progression-free Survival (PFS)

Serious Adverse Events Possibly, Probably or Definitely Related to Study Treatment

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nivolumab plus AxitinibExperimental Treatment2 Interventions

Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axitinib

2020

Completed Phase 2

~3050

Nivolumab

2014

Completed Phase 3

~5220

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yana NajjarLead Sponsor

5 Previous Clinical Trials

115 Total Patients Enrolled

5 Trials studying Melanoma

115 Patients Enrolled for Melanoma

PfizerIndustry Sponsor

4,625 Previous Clinical Trials

14,284,163 Total Patients Enrolled

53 Trials studying Melanoma

49,666 Patients Enrolled for Melanoma

Bristol-Myers SquibbIndustry Sponsor

2,678 Previous Clinical Trials

4,125,614 Total Patients Enrolled

179 Trials studying Melanoma

57,684 Patients Enrolled for Melanoma

Media Library

Axitinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04493203 — Phase 2

Melanoma Research Study Groups: Nivolumab plus Axitinib

Melanoma Clinical Trial 2023: Axitinib Highlights & Side Effects. Trial Name: NCT04493203 — Phase 2

Axitinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04493203 — Phase 2

~7 spots leftby Sep 2025

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