An Open-Label, 2-Cohort, Multicenter, Study of Lenvatinib in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma
Condition: Unresectable Stage III; Stage IV Melanoma
MeSH terms: Melanoma
Intervention: Lenvatinib
Intervention description: Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent.
Intervention MeSH terms: Lenvatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the objective response rate of lenvatinib in
      previously treated participants with American Joint Committee on Cancer (AJCC) unresectable
      Stage III or Stage IV melanoma and disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically confirmed diagnosis of melanoma.

          2. Unresectable Stage III or Stage IV melanoma.

          3. Evidence of disease progression according to RECIST 1.1 on prior regimen.

          4. Participants with brain metastases will be eligible if they have undergone complete
             surgical excision and are more then 1 month post surgery with no radiographic evidence
             of disease recurrence in the brain or have undergone stereotactic radio surgery (gamma
             knife procedure) and are more then 1 month post procedure and with no radiographic
             evidence of disease progression in the brain; and are asymptomatic, and discontinued
             corticosteroid treatment at least 30 days prior starting treatment.

          5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          6. Adequately controlled blood pressure.

          7. Adequate renal function, bone marrow function, blood coagulation function, and liver
             function, as defined in the study protocol.

        Exclusion Criteria:

          1. Melanoma of intraocular origin.

          2. Leptomeningeal metastases or brain metastases except as for participants with brain
             metastases will be eligible if they have undergone complete surgical excision and are
             more then 1 month post surgery with no radiographic evidence of disease recurrence in
             the brain or have undergone stereotactic radio surgery (gamma knife procedure) and are
             more then 1 month post procedure and with no radiographic evidence of disease
             progression in the brain; and are asymptomatic, and discontinued corticosteroid
             treatment at least 30 days prior starting treatment.

          3. More than 2 prior systemic anticancer regimen treatments including immunotherapies for
             unresectable Stage III or Stage IV disease (if BRAF V600E mutation negative) or not
             previously treated with BRAF V600E-targeted therapy or received in the past more than
             2 prior systemic anticancer regimen treatments, including immunotherapies, in addition
             to a BRAF-V600E-targeted therapy (if BRAF V600E mutation positive).

          4. Significant cardiovascular impairment.

          5. Bleeding disorder or a thrombotic disorder requiring anticoagulant therapy.

          6. Females who are pregnant or breastfeeding.

          7. Prolongation of QTc interval to greater than 480 msec.

          8. 24 hour urine protein greater than or equal to 1 gm.

          9. Active hemoptysis within 3 wks prior to the first dose of study drug.