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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
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The purpose of this study is to characterize the safety and tolerability and determine the maximum tolerated dose (MTD) or the recommended fixed dose of the combinations of Mogamulizumab and Nivolumab in subjects with locally advanced or metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mogamulizumab+Nivolumab | Experimental | During parts 1 and 2, Mogamulizumab and Nivolumab are administered at appropriate intervals. Part 1 (Dose Escalation Part) During Cohort 1 to 2, Mogamulizumab and Nivolumab are administered in combination. Part 2 (Expansion Part) Patients will be treated with maximum tolerated dose established in the dose escalation part for each combination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mogamulizumab: KW-0761, Nivolumab: (ONO-4538/BMS-936558) | Biological | i.v. administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects reporting adverse events | From the first dose of study medications until 90 days after the last dose of study medication | |
| Number of subjects reporting serious adverse events | From the first dose of study medications until 90 days after the last dose of study medication | |
| Percentage of subjects reporting serious adverse events | From the first dose of study medications until 90 days after the last dose of study medication | |
| Percentage of subjects reporting adverse events | From the first dose of study medications until 90 days after the last dose of study medication | |
| Number of subjects experiencing dose-limiting toxicity | For 28 days from the first dose of study medications |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiba | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31455681 | Derived | Doi T, Muro K, Ishii H, Kato T, Tsushima T, Takenoyama M, Oizumi S, Gemmoto K, Suna H, Enokitani K, Kawakami T, Nishikawa H, Yamamoto N. A Phase I Study of the Anti-CC Chemokine Receptor 4 Antibody, Mogamulizumab, in Combination with Nivolumab in Patients with Advanced or Metastatic Solid Tumors. Clin Cancer Res. 2019 Nov 15;25(22):6614-6622. doi: 10.1158/1078-0432.CCR-19-1090. Epub 2019 Aug 27. |
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| Tokyo |
| Japan |
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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