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To confirm the tolerability and safety of combined administration of ONO-7913, ONO-4538 and the standard of care FOLFOX in combination with bevacizumab or cetuximab as first-line treatment in patients with unresectable advanced or recurrent colorectal cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-7913＋ONO-4538＋FOLFOX＋Bev | Experimental |
| |
| ONO-7913＋ONO-4538＋FOLFOX＋Cet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-7913 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities（DLT） | 28 days | |
| Adverse event (AE) | Up to 30 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics（Plasma concentration of ONO-7913） | Through study completion, an average of 1 year. | |
| Pharmacokinetics（Plasma concentration of ONO-4538） | Through study completion, an average of 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujita Health University Hospital | Toyoake | Aichi-ken | Japan | |||
| National Cancer Center Hospital East |
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| ONO-4538 | Drug | Specified dose on specified days |
|
|
| Fluorouracil | Drug | Specified dose on specified days |
|
| Oxaliplatin | Drug | Specified dose on specified days |
|
| Levofolinate | Drug | Specified dose on specified days |
|
| Bevacizumab | Drug | Specified dose on specified days |
|
| Cetuximab | Drug | Specified dose on specified days |
|
| Objective Response Rate (ORR) | Through study completion, an average of 1 year. |
| Disease Control Rate (DCR) | Through study completion, an average of 1 year. |
| Overall Survival (OS) | Through study completion, an average of 3 years. |
| Progression-Free Survival (PFS) | Through study completion, an average of 1 years. |
| Duration of Response (DOR) | Through study completion, an average of 1 years. |
| Time to Response (TTR) | Through study completion, an average of 1 years. |
| Best Overall Response (BOR) | Through study completion, an average of 1 years. |
| Percent change in the sum diameters of the target lesions | Through study completion, an average of 1 years. |
| Maximum percent change in the sum diameters of the target lesions | Through study completion, an average of 1 years. |
| Early Tumor shrinkage（ETS） | Up to 8 weeks |
| Change From Baseline in Tumour Biomarkers (CEA and CA19-9) | Through study completion, an average of 1 year. |
| Kashiwa |
| Chiba |
| Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | Japan |
| Kobe City Medical Center General Hospital | Kobe | Hyōgo | Japan |
| St. Marianna University Hospital | Kawasaki | Kanagawa | Japan |
| Kanagawa Cancer Center | Yokohama | Kanagawa | Japan |
| Kurashiki Central Hospital | Kurashiki | Okayama-ken | Japan |
| Kansai Medical University Hospital | Hirakata | Osaka | Japan |
| Osaka Medical and Pharmaceutical University Hospital | Takatsuki | Osaka | Japan |
| Saitama Medical University International Medical Center | Hidaka | Saitama | Japan |
| Saitama Cancer Center | Shinden | Saitama | Japan |
| Cancer Institute Hospital of JFCR | Koto-Ku | Tokyo | Japan |
| National Cancer Center Hospital | Chūōku | Toyko | Japan |
| Chiba Cancer Center | Chiba | Japan |
| National Hospital Organization Osaka National Hospital | Osaka | Japan |
| Osaka General Medical Center | Osaka | Japan |
| Osaka International Cancer Institute | Osaka | Japan |
| ID | Term |
|---|---|
| C000629291 | magrolimab |
| D000077594 | Nivolumab |
| D005472 | Fluorouracil |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D000068258 | Bevacizumab |
| D000068818 | Cetuximab |
| 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 |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
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