Advanced KIT-mutant melanoma Other disease of skin or skin tissue
Conditions
Interventions
P1: 3+3 design to evaluate safety and tolerability and identify maximum tolerated dose/administered.
Level 1: Imatinib 200 mg/day, QD (day at 1-21), pembrolizumab 200 mg/body, Q3W (day at 1)
Level 2:
Sponsors
Funakoshi Takeru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 20 years or older on day of signing consent. 2) Has histologically or cytologically confirmed as malignant melanoma. 3) Has unresectable or metastatic KIT-mutant melanoma 4) Patients which is not controlled by standard therapy (immune checkpoint inhibitor, molecular target drug etc.) 5) Has been untreated for advanced or metastatic disease by imatinib. 6) Has resolution of toxic effects of the most recent prior therapy. 7) Has the presence of at least one measurable lesion by image per RECIST 1.1. 8) Has an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. 9) Life expectancy of greater than 90 days 10) Has no-central nerve system (CNS) metastasis or asymptomatic CNS metastasis. 11) Agreed to use an adequate method of contraception within the project duration of the study, starting with the visit through 120 days after the last dose of the study treatment. 12) Has laboratory parameters within Protocol-defined range. The screening laboratory tests below must be = 2,000/mm3 , absolute neutrophil count >= 1,500/mm3 -Platelets >= 100,000/mm3 -Hemoglobin >= 9.0g/dl -Aspartate aminotransferase (AST), alanine aminotransferase (ALT) <= 150 IU/L -Bilirubin <= 2.0mg/dl -Serum creatinine <= 1.5mg/dl 13) Provide written informed consent for the study.
Exclusion criteria
Exclusion criteria: 1) Seropositivity to HBsAg or HCVAb. 2) Has known history of HIV. 3) Has active infection, clinically significant cardiac disease, including unstable angina and arrhythmia, interstitial pneumonia, psychiatric disorder. 4) Has grade 3 or worse superior vena cava syndrome, pericardial effusion, pleural effusion, ascites. 5) Has uncontrolled disease that might confound the results of the study, or is not best interest of the subject to participate, in the opinion of the treating investigator. 6) Has double cancer (completely resected basal cell carcinoma, carcinoma in situ, or superficial bladder cancer, or patients with other cancers that do not show recurrence for more than 3 years before obtaining consent)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate after administration of four dosing cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, overall survival, best overall response, adverse event type/ frequency/ severity (CTCAE 5.0). | — |
Contacts
Public ContactTakeru Funakoshi
Department of Dermatology Keio University School of Medicine
Outcome results
None listed