Study on Axitinib and Ipilimumab for Treating Advanced Melanoma

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04996823

Provider View

This clinical trial is exploring whether a combination of the drugs axitinib and ipilimumab can effectively treat advanced melanoma, especially in patients who have not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to determine if taking axitinib together with ipilimumab can help treat advanced melanoma, a type of skin cancer that has spread or cannot be removed by surgery. The study will also assess the safety and tolerability of this drug combination in patients who have not responded to other treatments like anti-PD-1/PD-L1 therapy and have not previously been treated with ipilimumab.

Description

This clinical trial is testing a new treatment approach for advanced melanoma by combining two drugs, axitinib and ipilimumab. The study aims to find out if this combination is safe and can help control the cancer in patients who have not responded to other treatments. Participants must have advanced melanoma that cannot be surgically removed, and they should not have received ipilimumab before. The trial will monitor how well patients tolerate the treatment and whether it helps reduce the cancer.

Eligibility Criteria

Inclusion Criteria

  • Have advanced melanoma that cannot be surgically removed (excluding uveal melanoma).
  • Be in relatively good health with an ECOG performance status of 2 or less.
  • Have adequate bone marrow and organ function based on specific lab tests.
  • Have controlled blood pressure below 150/100.
  • Have at least one measurable tumor.
  • Have melanoma that did not respond to or was intolerant to anti-PD-1/PD-L1 treatment.
  • If the melanoma has a BRAFV600 mutation, may have had prior BRAF/MEK inhibitor therapy.
  • No limit on previous treatments, but must not have had ipilimumab before.
  • Any previous treatment-related side effects must be resolved to a mild level.
  • Can have other cancers if they do not interfere with this study.
  • Must be at least two weeks from any major surgery before starting the study.
  • Must be able to have a tumor biopsy before and during treatment.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception. Men must also agree to use contraception.
  • Patients with treated brain metastases can participate if they are stable and not requiring steroids.
  • Cannot have active autoimmune disease needing treatment, but replacement therapy is allowed.
  • Patients with HIV can participate if they are on effective treatment with an undetectable viral load. Patients with hepatitis C must be treated and cured, or have an undetectable viral load if still on treatment.

Exclusion Criteria

  • Patients with severe liver impairment (Child Pugh C) are excluded.
  • Patients with significant bleeding (Grade 3 or higher) in the last 4 weeks are excluded.
  • Patients with severe heart conditions or heart failure in the last 6 months are excluded.
  • Patients who had a stroke or mini-stroke in the last 6 months are excluded.
  • Patients using or needing drugs that strongly affect liver enzymes (CYP3A4/5) within 10 days before starting the study are excluded.

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