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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3475-D35 (KEYNOTE-D35) | Other Identifier | Merck Sharp & Dohme LLC |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This study is a phase 1B/2 open-label, study to determine safety and preliminary efficacy of Q702 in combination with pembrolizumab in study subjects with advanced esophageal, gastric/GEJ, hepatocellular, and cervical cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation of Q702 in combination with fixed dose of pembrolizumab | Experimental | Give one week on/one week off at selected dose level |
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| Dose expansion of Q702 in combination with fixed dose of pembrolizumab | Experimental | Give intravenously once every three week at 200 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Q702 | Drug | The study drug Q702 will be administered once daily by mouth on Days 1 through 7, Days 15 through 21 and Days 29 through 35 of every treatment cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE | Up to approximately 2 years (Each Cycle is 42 Days) | |
| Tumor response using RECIST version 1.1 throughout study | Up to approximately 2 years (Each Cycle is 42 Days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the area under curve (AUC) of Q702 and its primary metabolites | Cycle 1 Day 1 and Day 22 (Each Cycle is 42 Days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Norton Cancer Institute |
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| Pembrolizumab | Biological | Pembrolizumab will be administered using IV infusion on Day 1 of each 3-week treatment cycle |
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|
| Louisville |
| Kentucky |
| 40202 |
| United States |
| CHA Bundang Medical Center | Seongnam-si | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D008113 | Liver Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D008107 | Liver Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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