Clinical Trials /

Axitinib + Ipilimumab in Advanced Melanoma



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

Related Conditions:
  • Melanoma
Recruiting Status:



Phase 2

Trial Eligibility



  • Brief Title: Axitinib + Ipilimumab in Advanced Melanoma
  • Official Title: Phase 2 Study of Axitinib + Ipilimumab in Advanced Melanoma

Clinical Trial IDs

  • ORG STUDY ID: MCC-21112
  • SECONDARY ID: 63403991
  • NCT ID: NCT04996823


  • Melanoma


IpilimumabYervoyIpilimumab + Axtinib
AxitinibInlytaIpilimumab + Axtinib


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.

Trial Arms

Ipilimumab + AxtinibExperimentalParticipants will receive treatment with ipilimumab 3 mg/kg IV q3 weeks x 4 doses and axitinib at 5 mg by mouth twice daily. Each cycle is 3 weeks/21 days
  • Ipilimumab
  • Axitinib

Eligibility Criteria

        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

          -  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

          -  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 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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response Rate
Time Frame:Up to 24 months
Safety Issue:
Description:Overall Response Rate (ORR) defined as proportion of patients to have achieved a complete or partial response per irRECIST and RECIST v1.1 criteria.

Secondary Outcome Measures

Measure:Progression Free Survival
Time Frame:Up to 5 years
Safety Issue:
Description:Progression Free Survival (PFS) is defined as the length of time from start of study treatment to the earlier of the first documentation of disease progression or death from any cause.
Measure:Overall Survival
Time Frame:Up to 5 years
Safety Issue:
Description:Overall Survival (OS) is defined as the length of time from start of treatment to date of death from any cause.
Measure:Duration of Response
Time Frame:Up to 5 years
Safety Issue:
Description:Duration of Response is defined as the interval from the first documentation of Complete Response (CR) or Partial Response (PR) to documentation of progressive disease or death from any cause.
Measure:Clinical Benefit Rate
Time Frame:Up to 12 months
Safety Issue:
Description:Clinical Benefit Rate is defined as the proportion of patients who achieve a Complete Response (CR), Partial Response (PR) or durable Stable Disease (SD) of at least 6 months from start of study treatment.


Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute

Trial Keywords

  • skin cancer

Last Updated

August 12, 2021