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This is a Phase II single center, open-label, single arm study in patients with advanced thymic epithelial tumors after failure of cisplatin-based combination chemotherapy. Patients will be treated with Pembrolizumab 200 mg every 3 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Pembrolizumab 200mg IV every 3 weeks until tumor progression or unacceptable toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | treated with Pembrolizumab 200 mg every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate by RECIST 1.1 | complete response plus partial response as determined by RECIST 1.1 | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | include safety profiles | 24 months |
| Progression free survival | time from the on-study date to date of disease progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myung-Ju Ahn, Prof. | Samsung Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30647082 | Derived | Kim KH, Cho J, Ku BM, Koh J, Sun JM, Lee SH, Ahn JS, Cheon J, Min YJ, Park SH, Park K, Ahn MJ, Shin EC. The First-week Proliferative Response of Peripheral Blood PD-1+CD8+ T Cells Predicts the Response to Anti-PD-1 Therapy in Solid Tumors. Clin Cancer Res. 2019 Apr 1;25(7):2144-2154. doi: 10.1158/1078-0432.CCR-18-1449. Epub 2019 Jan 15. |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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| 24 months |
| Overall survival | time from the on-study date to death as a result of any cause | 24 months |