Imatinib Mesylate in Combination With Pembrolizumab in Patients With Melanoma

Inclusion Criteria

• •1\. Be male or female subjects, age 20 years or older on day of signing consent.
• •2\. Have histologically confirmed melanoma.
• •3\. Have unresectable or metastatic melanoma with KIT mutations detected by next-generation sequencing which was performed at clinical laboratories accredited by international standards such as CLIA and CAP certification.
• •4\. Have progressed on treatment with an anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria:
• •1. Received at least 2 doses of an approved anti-PD-1/L1 mAb.
• •2. Has demonstrated disease progression after PD-1/L1 as defined by RECIST 1.1. The initial evidence of disease progression is to be confirmed by second assessment no less than 4 weeks from the date of the first documented progressive disease, in the absence of rapid clinical progression. This determination is made by the investigator. Once progressive disease is confirmed, the initial date of progressive disease documentation will be considered the date of disease progression.
• •3. Progressive disease has been documented within 12 weeks from the last dose of anti-PD-1/L1 mAb or during the treatment. In adjuvant therapy, progressive disease has been documented within 6 months from the last dose of anti-PD-1/L1 mAb or during the treatment.
• •5\. Have no prior treatment with KIT inhibitors.
• •6\. Have completed previous therapies 21 days prior to enrollment on study.
• •7\. Have the presence of at least one measurable lesion by CT or MRI per RECIST 1.1 criteria as determined by the local site investigator/radiology assessment within 14-days prior to enrollment on study.
• •8\. Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
• •9\. Have life expectancy of greater than 90 days.
• •10\. Have known no active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 28 days before enrollment on study and any neurologic symptoms).
• •11\. If female of childbearing potential, must be willing to use an adequate method of contraception and agree not to breastfeed for the course of the study through 120 days after the last dose of study medication. If male of childbearing potential, must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication.
• •12\. Have laboratory parameters within Protocol-defined range. The screening laboratory tests below must be ≤14 days before enrollment on study.
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• •1. White blood cell count ≥ 2,000/mm\^3 and absolute neutrophil count ≥1,500/mm\^3.
• •2. Platelets ≥ 100,000/mm\^3.
• •3. Hemoglobin ≥ 9 g/dL.
• •4. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 150 IU/L.
• •5. Bilirubin ≤ 2.0 mg/dl.
• •6. Serum creatinine ≤ 1.5 mg/dl. 13. Be willing and able to review, understand and provide written consent before starting therapy.