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To evaluate the tolerability and safety of combination of ONO-4578 and ONO-4538 and the standard of care XELOX + bevacizumab or the safety of combination of ONO-4578 and ONO-4538 and the standard of care FOLFOX + bevacizumab as first-line therapy in patients with unresectable, advanced, or recurrent colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-4578+ONO-4538+XELOX plus bevacizumab | Experimental |
| |
| ONO-4578+ONO-4538+FOLFOX plus bevacizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-4578 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of AEs and SAEs | up to 3years | |
| Incidence and severity of clinical laboratory abnormalities | up to 3years | |
| 12-lead electrocardiography (Heart rate) | up to 3years | |
| 12-lead electrocardiography (PR interval) | up to 3years | |
| 12-lead electrocardiography (RR interval) | up to 3years | |
| 12-lead electrocardiography (QRS width) | up to 3years | |
| 12-lead electrocardiography (QT interval) | up to 3years | |
| Chest X-ray test | up to 3years | |
| ECOG performance status | up to 3years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | up to 3years | |
| Disease control rate (DCR) | up to 3years | |
| Overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Project Leader | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Hospital East | Kashiwa-shi | Chiba | Japan | |||
| Kobe City Hospital Organization Kobe City Medical Center General Hospital |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| ONO-4538 | Drug | Specified dose on specified days |
|
|
| Capecitabine | Drug | Specified dose on specified days |
|
|
| Oxaliplatin | Drug | Specified dose on specified days |
|
|
| Fluorouracil | Drug | Specified dose on specified days |
|
|
| Calcium Levofolinate Hydrateb | Drug | Specified dose on specified days |
|
|
| Bevacizumab | Drug | Specified dose on specified days |
|
|
| up to 3years |
| Progression-free survival (PFS) | up to 3years |
| Duration of response (DOR) | up to 3years |
| Time to response (TTR) | up to 3years |
| Best oveall response (BOR) | up to 3years |
| Percentage of change in the sum of tumor diameters of target lesions | up to 3years |
| Maximum percent change in the sum diameters of the target lesions | up to 3years |
| Time course of tumor markers | up to 3years |
| Plasma ONO-4578 concentration | up to 3years |
| Serum ONO-4538 concentration | up to 3years |
| Anti-ONO-4538 antibody | up to 3years |
| Kobe |
| Hyōgo |
| Japan |
| Kanagawa Cancer Center | Yokohama | Kanagawa | Japan |
| Saitama Cancer Center | Ina | Kitaadati-gun, Saitama | Japan |
| NHO Osaka National Hospital | Osaka | Osaka | Japan |
| Osaka General Medical Center | Osaka | Osaka | Japan |
| Osaka Medical and Pharmaceutical University Hospital | Takatsuki-shi | Osaka | Japan |
| Saitama Medical University International Medical Center | Hidaka-shi | Saitama | Japan |
| Cancer Institute Hospital of JFCR | Koto-Ku | Tokyo | Japan |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |