JPRN-jRCTs031190202RecruitingPhase 1
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:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 22
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
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 < 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.
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)
Investigators
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