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Nivolumab + Axitinib for Advanced Melanoma
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Nivolumab plus Axitinib
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
What have patients reported as adverse effects of Axitinib?
"Axitinib's safety is rated as a 2 by our team at Power. This reflects that, while Phase 2 trials have not yielded evidence of efficacy, there is some data supporting Axitinib's safety profile."
How many individuals can enroll in this research project?
"That is correct, the clinical trial indicated on clinicaltrials.gov is still recruiting patients. This particular study was posted on December 18th, 2020 and was last edited April 19th, 2022. They are searching for 31 participants from 1 site."
Are there other research papers which feature Axitinib?
"Axitinib is being trialed in 790 studies worldwide, with 86 of those in the crucial third stage. Most trials are based out of Basel, BE, but there are 40953 locations running Axitinib trials."
What conditions does Axitinib commonly target?
"Axitinib is primarily used to fight malignant neoplasms, but it has also been shown to be useful in treating other conditions such as unresectable melanoma and squamous cell carcinoma."
Can anyone sign up for this test currently?
"Yes, this study is looking for volunteers at the moment. According to clinicaltrials.gov, the trial was first advertised on December 18th 2020 and updated as recently as April 19th 2022."
Does this trial pave the way for other similar studies?
"Axitinib has a long clinical history, with the first trial being performed in 2010. After the initial study - which only had 127 participants - Axitinib was approved for Phase 1 drugs. As of now, there are 790 live studies involving Axitinib across 2426 cities and 51 countries."
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