Actively Recruiting
Axitinib + Ipilimumab in Advanced Melanoma
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2025-12-04
25
Participants Needed
1
Research Sites
294 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical research study is to find out if taking axitinib with ipilimumab is effective in treating advanced melanoma.
CONDITIONS
Official Title
Axitinib + Ipilimumab in Advanced Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of advanced or unresectable melanoma (uveal melanoma excluded)
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Adequate bone marrow, organ function, and laboratory parameters
- Controlled blood pressure below 150 systolic and 100 diastolic
- At least one measurable lesion per irRECIST 1.1 criteria
- Disease refractory or intolerant to anti-PD-1/PD-L1 inhibitor treatment in metastatic or recent adjuvant setting
- Prior BRAF/MEK inhibitor therapy or intolerance allowed for BRAFV600-mutant melanoma
- No previous treatment with ipilimumab
- Prior treatment-related toxicity resolved to Grade 2 or baseline
- Prior or concurrent malignancy allowed if it does not interfere with safety or efficacy
- At least two weeks from any prior major surgery before first study dose
- Able to undergo pre-treatment and on-treatment tumor biopsy
- Female participants of childbearing potential must have negative pregnancy test and agree to highly effective contraception
- Male participants must agree to use highly effective contraception
- Patients with previously treated brain metastases allowed if stable and not requiring corticosteroids
- Controlled autoimmune diseases allowed excluding those requiring disease-modifying therapy
- Participants with HIV on effective therapy with undetectable viral load eligible
- Participants with treated and cured hepatitis C infection eligible
- Participants currently on hepatitis C treatment must have undetectable viral load before study start
You will not qualify if you...
- Severe hepatic impairment (Child Pugh C) in patients with known liver cirrhosis
- Grade 3 or higher hemorrhage within 4 weeks prior to study
- Severe or unstable angina or symptomatic congestive heart failure within last 6 months
- Cerebrovascular accident or transient ischemic attack within last 6 months
- Current use or planned use of strong CYP3A4/5 inhibitors or inducers within 10 days prior to treatment start
- Pregnant or breastfeeding women
- Uncontrolled or symptomatic brain metastases or leptomeningeal carcinomatosis requiring corticosteroids
- Active autoimmune disease requiring disease-modifying therapy at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
A
Arnay Marshall
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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