RecruitingPhase 2NCT04996823

Axitinib + Ipilimumab in Advanced Melanoma

Phase 2 Study of Axitinib + Ipilimumab in Advanced Melanoma


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

25 participants

Start Date

Aug 4, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical research study is to find out if taking axitinib with ipilimumab is effective in treating advanced melanoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the combination of axitinib (a drug that cuts off tumor blood supply) and ipilimumab (an immune checkpoint drug) in patients with advanced melanoma (skin cancer) whose cancer has already progressed on prior anti-PD-1 immunotherapy. **You may be eligible if...** - You are 18 or older with advanced or unresectable melanoma (not uveal/eye melanoma) - Your cancer has progressed on or within 6 months of completing anti-PD-1 immunotherapy - You have at least one measurable tumor - You are in good health (ECOG 0–2) with controlled blood pressure - You have not previously received ipilimumab - You are able to provide tumor biopsy samples (before and during treatment) **You may NOT be eligible if...** - You have active autoimmune disease requiring medication - You have severe heart disease (recent heart attack, severe heart failure, or stroke within 6 months) - You have active brain metastases requiring steroids or that are uncontrolled - You have had significant bleeding (grade 3 or higher) within 4 weeks - You are taking strong medications that affect liver enzyme CYP3A4/5 - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIpilimumab

Participants will receive ipilimumab 3mg/kg IV every 3 weeks for up to 4 doses.

DRUGAxitinib

Participants will take 5 mg Axitinib twice daily by mouth for up to 35 cycles (24 months)


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT04996823


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