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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
No Placebo-Only Group
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 belowSelect...
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:Select...
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
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
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: 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
2015
Completed Phase 3
~4010
Find a Location
Who is running the clinical trial?
Yana NajjarLead Sponsor
5 Previous Clinical Trials
115 Total Patients Enrolled
PfizerIndustry Sponsor
4,658 Previous Clinical Trials
17,877,394 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,682 Previous Clinical Trials
4,129,538 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to nivolumab or axitinib, or any of the ingredients in these medications.I am not pregnant, using birth control, sterile, or abstaining from sex for the study duration and 5 months after.I have severe heart failure.I have HIV with specific CD4 count and viral load levels.I have had a severe hypertension crisis or brain issues due to high blood pressure.I had side effects from previous cancer immunotherapy that haven't fully improved.I haven't had a heart attack, severe heart rhythm problems, stroke, or very high blood pressure needing ICU care in the last 6 months.I haven't had chemotherapy or targeted therapy in the last week and have recovered from previous treatments.My melanoma cannot be removed by surgery and is not uveal melanoma.I have never had myocarditis, Guillain-Barre syndrome, encephalitis, meningitis, transverse myelitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis.I have received radiation therapy within the last 2 weeks.I do not have active brain cancer or symptoms from past brain cancer.My cancer worsened after treatment with anti-PD1, possibly with anti-CTLA4, confirmed by scans.I agree to use or continue using contraception or practice abstinence for 7 months after my last treatment dose.I have not needed systemic treatment for an autoimmune disease in the last 2 years.You have a disease that can be measured using a specific set of guidelines.I have had severe side effects from previous immune treatments that made me stop the treatment.I am not using or planning to use strong CYP3A4/5 inhibitors or eat grapefruit.I am currently on IV antibiotics for an infection.You have a history of or test positive for hepatitis B or C. If there are signs of these infections, you will be tested.I have mild to moderate nerve pain or damage but can still qualify for the study.My brain cancer has been stable for 2 weeks, either without symptoms or after treatment.I have recovered from any major surgery before starting treatment.I am not on high-dose steroids or immunosuppressants.My organs are functioning well.I have a condition that affects my ability to absorb oral medications.My blood pressure is high even with medication.I am not using or planning to use strong CYP3A4/5 inducers like carbamazepine or St. John's wort.I have an active tuberculosis infection.I have not had major surgery in the last 4 weeks.I have not received a live vaccine in the last 30 days.I am fully active or restricted in physically strenuous activity but can do light work.I have had pneumonitis treated with steroids or have it now.I have not had a major clotting or bleeding event in the last 6 months.I have another cancer, but it's either not spreading or not being treated, except for certain skin, cervical, colon cancers, or non-spreading prostate cancer.I don't need a biopsy to join, but if I can have one, I must do it now and at week 12.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab plus Axitinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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