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Tyrosine Kinase Inhibitor
Axitinib + Nivolumab for Melanoma
Phase 2
Recruiting
Led By Alexander Shoushtari, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Summary
This trial will test whether the combination of axitinib and nivolumab is an effective and safe treatment for people with advanced or metastatic mucosal melanoma.
Who is the study for?
Adults with advanced mucosal melanoma that hasn't been treated before can join this trial. They should have a certain type of tumor, be in good enough health to perform daily activities (ECOG 0-2), and not be pregnant or breastfeeding. Participants must agree to use two contraception methods if applicable. People with severe allergies to the drugs, autoimmune diseases needing steroids, recent heart issues, or specific blood disorders cannot join.
What is being tested?
The study is testing whether axitinib combined with nivolumab is effective for treating advanced mucosal melanoma. Axitinib blocks cancer cell growth signals while nivolumab boosts the immune system's response against cancer cells. The hope is that together they work better than alone.
What are the potential side effects?
Possible side effects include allergic reactions, fatigue, high blood pressure from axitinib; and skin rash, liver inflammation, lung problems like pneumonitis from nivolumab. There may also be risks related to combining these medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
best objective response
Trial Design
1Treatment groups
Experimental Treatment
Group I: Axitinib and Nivolumab for the Treatment of Mucosal MelanomaExperimental Treatment3 Interventions
This is a single center trial enrolling up to 20 total evaluable patients with unresectable primary or advanced mucosal melanomas arising from the head and neck, gastrointestinal, or genitourinary tract to receive frontline therapy with nivolumab IV 480mg q4 weeks plus axitinib 5mg PO twice daily. A Simon 2-stage design will be utilized. Upon progression with good tolerance, addition of stereotactive body radiation therapy (SBRT) or CTLA-4 blockade to continued nivolumab plus axitinib will be offered to patients depending on the type of progression. For patients with local or oligometastatic progression, stereotactic body radiotherapy (SBRT) will be added; for patients with progression in a site of prior radiotherapy or with multifocal or distant progression not amenable to SBRT, ipilimumab 1mg/kg IV q3 weeks for up to 4 doses will be added.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
axitinib
2016
Completed Phase 2
~2390
Stereotactic Body Radiation Therapy (SBRT)
2018
Completed Phase 2
~740
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,958 Previous Clinical Trials
595,876 Total Patients Enrolled
76 Trials studying Melanoma
15,924 Patients Enrolled for Melanoma
PfizerIndustry Sponsor
4,627 Previous Clinical Trials
14,282,015 Total Patients Enrolled
53 Trials studying Melanoma
49,565 Patients Enrolled for Melanoma
Alexander Shoushtari, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
29 Total Patients Enrolled
3 Trials studying Melanoma
29 Patients Enrolled for Melanoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had heart issues within a specific timeframe.I am 18 years old or older.My melanoma cannot be removed by surgery and started in specific areas like the mouth, nose, or genitals.I don't have current bleeding issues or recent serious blood clots.I have not had any systemic therapy for my condition before joining this study.I am using two effective birth control methods and will continue for 23 weeks after my last treatment dose.I am currently receiving treatment for another cancer.I have a condition that makes me more sensitive to radiation.I can take care of myself and perform daily activities.I am currently pregnant or breastfeeding.I have brain metastases but no symptoms, or they are treated and stable without increased steroids recently.I haven't taken steroids or immunosuppressants for my autoimmune disease in the last 14 days.I have a history of motor neuropathy, myocarditis, or non-infectious pneumonitis.I have a cancerous growth outside my brain that can't be surgically removed but can be seen on scans.I do not have any serious infections.
Research Study Groups:
This trial has the following groups:- Group 1: Axitinib and Nivolumab for the Treatment of Mucosal Melanoma
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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