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| ID | Type | Description | Link |
|---|---|---|---|
| KEYNOTE-899 | Other Identifier | Merck Sharp & Dohme LLC | |
| MK-3475-899 | Other Identifier | Merck Sharp & Dohme LLC |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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To evaluate the safety and tolerability of escalating doses GX-I7 in combination with standard dose pembrolizumab, and to evaluate objective response rate (ORR) in subjects with refractory or relapsed TNBC
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combination with CPA, GX-I7, and pembrolizumab | Experimental | Experimental: combination Assigned interventions: CPA, GX-I7 and pembrolizumab |
|
| combination with GX-I7, and pembrolizumab | Experimental | Experimental: combination Assigned interventions: GX-I7 and pembrolizumab (without CPA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GX-I7 | Drug | i.m. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and nature of DLTs | To evaluate the safety and tolerability of GX-I7 in combination with standard dose pembrolizumab | during the first 5 weeks |
| Incidence, nature and severity of adverse events | graded according to NCI CTCAE v5.0 | up to 24month |
| Objective response rate (ORR) | defined as percentage of subjects with a complete response (CR) or partial response (PR) per RECIST v.1.1 | up to 24month |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | South Korea | |||
| Ajou Medical Center |
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| Pembrolizumab(KEYTRUDA®) | Drug | i.v. |
|
|
| Cyclophosphamide | Drug | i.v. |
|
| Suwon |
| Gyeonggi-do |
| South Korea |
| National Cancer Center | Goyang-si | South Korea |
| Gachon University Gil Medical Center | Incheon | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul ST.Mary's Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000712767 | efineptakin alfa |
| C582435 | pembrolizumab |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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