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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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Investigators have conducted K-BASKET trial (Korea-Biomarker-driven multi-arm drug-screening, knowledge and evidence-generating targeted trial), which was based on the specific genetic aberration, not the cancer type, which could accelerate matching the right drug to the right target so that every cancer patient could get the right specific drug based on the specific genetic biomarker, like NCI-MATCH trial. Next generation sequencing (NGS) focusing panel has the mutation and copy number variation of MET, PIK3CA and AKT. Investigators will open new treatment arms during the progress of K-BASKET trial. Patient with PD-L1 positive or EBV positive or MSI-H or POLE/POLD1 mutation tumor will be assigned to Avelumab monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| avelumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avelumab | Drug | avelumab 10mg/kg, IV, q 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| safety assessed by CTCAE v4.0 | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 2 weeks |
| disease control rate | 6 weeks |
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Inclusion Criteria:
A. Adequate hematological function defined by absolute neutrophil count (ANC) ≥ 1500/mm3, platelet count ≥ 100,000/mm3 , hemoglobin ≥ 9.0 g/dL B. Adequate hepatic function defined by AST and ALT levels ≤ 2.5 × upper limit of normal (ULN) and total bilirubin level ≤ 1.5 × ULN C. Adequate renal function defined by and estimated creatinine clearance (CrCl) ≥ 30 mL/min (MDRD)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Medical Oncology, Severance Breast Cancer Clinic, Yonsei Cancer Center, Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
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| ID | Term |
|---|---|
| C000609138 | avelumab |
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| progression free survival | 4 weeks |