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| Name | Class |
|---|---|
| Kyowa Kirin Co., Ltd. | INDUSTRY |
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
| Clinical Study Support, Inc. | UNKNOWN |
| Fiverings Co., Ltd. |
To assess the safety of preoperative combination therapy with KW-0761 (anti-CCR4) and ONO-4538 (anti-PD-1).
To assess the behavior of immune cells in peripheral blood and tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | KW-0761 (Mogamulizumab): 0.1 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times |
|
| Cohort 2 | Experimental | KW-0761 (Mogamulizumab): 0.3 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times |
|
| Cohort 3 | Experimental | KW-0761 (Mogamulizumab): 1.0 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mogamulizumab | Biological | Mogamulizumab (0.1, 0.3 or 1.0 mg/kg) is administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events including intraoperative and postoperative complications | Confirm the toxicity profile, which is measured by the degree of grade and seriousness, duration, causality, classification, etc. of the adverse events. | from first administration to 60 days after the final administration or to 30 days after the standard operation |
| Rate of Foxp3-positive patients in tumor by immunohistochemical analysis | from baseline until standard operation, an average of 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective tumor response rate according to RECIST v1.1 | from baseline to 6 weeks after the first administration | |
| Rate of Treg decrease in peripheral blood mononuclear cell (PBMC) | from baseline to 60 days after the final administration or to 30 days after the standard operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hisashi Wada, M.D., Ph.D | Department of Clinical Research in Tumor Immunology, Graduate School of Medicine, Osaka University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka University | Suita | Osaka | 5650871 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40180420 | Derived | Jinushi K, Saito T, Kurose K, Suzuki S, Kojima T, Takahara T, Makino T, Ogawa T, Nishikawa H, Kakimi K, Iida S, Nakajima J, Doki Y, Oka M, Ueda R, Wada H. Phase I study on neoadjuvant combination immunotherapy with mogamulizumab and nivolumab for solid tumors. J Immunother Cancer. 2025 Apr 2;13(4):e010634. doi: 10.1136/jitc-2024-010634. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| D008175 | Lung Neoplasms |
| D007680 | Kidney Neoplasms |
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C549035 | mogamulizumab |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| OTHER |
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| Nivolumab | Biological | Nivolumab (3.0 mg/kg) is administered. |
|
|
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |