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Axitinib + Ipilimumab for Advanced Melanoma

This study is looking at whether combining two medications, axitinib and ipilimumab, is an effective treatment for advanced melanoma. You might be able to join if you have advanced melanoma (excluding uveal melanoma), are at least 18 years old, and meet certain health requirements like good organ function and controlled blood pressure. This study is for people who haven't responded well to other treatments for melanoma (anti-PD-1/PD-L1 therapy) and haven't received ipilimumab before. The main goal is to see how many participants respond to the treatment over 24 months. The current status of this study is unclear, meaning it might not be actively recruiting.

Study design
This study plans to enroll 25 participants. It is an interventional study, meaning participants will receive specific treatments.
What's involved
Participants will receive ipilimumab intravenously (IV) every 3 weeks for up to 4 doses. They will also take axitinib by mouth twice daily for up to 35 cycles (24 months).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Overall Response Rate, is measured for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04996823

Axitinib + Ipilimumab in Advanced Melanoma

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~24 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:IpilimumabAxitinib

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate
Measured over Up to 24 months

Conditions

Melanoma

Explore related trials

Melanoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Zeynep Eroglu, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of advanced/unresectable melanoma - uveal melanoma is excluded
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Adequate bone marrow, organ function and laboratory parameters as defined in protocol.
Patients must have adequately controlled blood pressure (\<150 systolic and \<100 diastolic)
At least 1 measurable lesion - per irRECIST 1.1 criteria
Documented disease refractory or intolerant to anti-PD-1/PD-L1 inhibitor treatment: in the metastatic setting or in the adjuvant setting if relapse on or within 6 months from end of anti-PD-1 treatment
If BRAFV600-mutant melanoma, patients may have had prior BRAF/MEK inhibitor therapy, or intolerance to these drugs
No limit to prior lines of treatment but prior ipilimumab not permitted
Prior treatment-related toxicity resolved to ≤ Grade 2 or baseline
Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Prior to first dose of study treatment, patients must be at least 2 weeks from any prior major surgery.
Able to undergo a pre-treatment and on-treatment tumor biopsy
Female participants of childbearing potential must have a negative serum or urine β-HCG test result. Female participants of childbearing potential and male participants must agree to use methods of contraception that are highly effective. Pregnant or breast-feeding patients are not permitted to enroll.
Patients with brain metastases are permitted assuming that the brain metastases have been adequately treated previously. Patients with uncontrolled or symptomatic brain metastases or leptomeningeal carcinomatosis that are not stable or require corticosteroids are not permitted,
Active autoimmune disease requiring disease-modifying therapy at the time of screening is not permitted. Replacement therapy (e.g., physiologic corticosteroid therapy) is allowed
Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 90 days prior to screening. Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load prior to study start.

Exclusion

In patients with known liver cirrhosis, those with severe (Child Pugh C) hepatic impairment are excluded.
Patients with Grade ≥3 hemorrhage within 4 weeks are excluded
Patients with severe/unstable angina or symptomatic congestive heart failure within last 6 months are excluded
Patients with cerebrovascular accident, transient ischemic attack within last 6 months are excluded.
Patients with current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors or strong CYP3A4/5 inducers, including their administration within 10 days prior to treatment start, are excluded.

What this trial measures

  • Overall Response RateUp to 24 months

    Overall Response Rate (ORR) defined as proportion of patients to have achieved a complete or partial response per irRECIST and RECIST v1.1 criteria.