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Axitinib + Ipilimumab in Advanced Melanoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Axitinib + Ipilimumab in Advanced Melanoma

Phase 2 Study of Axitinib + Ipilimumab in Advanced Melanoma

NCT04996823•H. Lee Moffitt Cancer Center and Research Institute

Summary

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

Detailed Description

The safety and tolerability of the combination of ipilimumab and axitinib will be tested in advanced melanoma patients who are intolerable/refractory to anti-PD-1/PD-L1 therapy and have not previously received treatment with ipilimumab.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
+6 more criteria

Exclusion Criteria

•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.

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States

Key Dates

Start Date

August 4, 2021

Primary Completion Date

August 20, 2026

Completion Date

March 29, 2027

Last Updated

December 4, 2025

Enrollment

ESTIMATED participants

Conditions

Melanoma

Interventions

Ipilimumab

DRUG

Axitinib

DRUG

Contacts

Arnay Marshall

CONTACT

813-745-5938 Arnay.Marshall@moffitt.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Axitinib + Ipilimumab in Advanced Melanoma

Inclusion Criteria

Exclusion Criteria

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