Imatinib in combination with Pembrolizumab in patients with advanced KIT-mutant melanoma following progression on standard therapy: a phase I/II trial (IMPAKT trial) - IMPAKT trial

Funakoshi Takeru0 sites22 target enrollmentStarted: February 5, 2020Last updated: October 17, 2023

Conditions

Trial Snapshot

No summary available.

•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 < 14 days before treatment initiation.
•-White blood cell count >= 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.

•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)

Sponsor

Funakoshi Takeru