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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Saitama Cancer Center
Incidence and severity of AEs and SAEs
Time frame: up to 3years
Incidence and severity of clinical laboratory abnormalities
Time frame: up to 3years
12-lead electrocardiography (Heart rate)
Time frame: up to 3years
12-lead electrocardiography (PR interval)
Time frame: up to 3years
12-lead electrocardiography (RR interval)
Time frame: up to 3years
12-lead electrocardiography (QRS width)
Time frame: up to 3years
12-lead electrocardiography (QT interval)
Time frame: up to 3years
Chest X-ray test
Time frame: up to 3years
ECOG performance status
Time frame: up to 3years
Objective response rate (ORR)
Time frame: up to 3years
Disease control rate (DCR)
Time frame: up to 3years
Overall survival (OS)
Time frame: up to 3years
Progression-free survival (PFS)
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Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
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
Time frame: up to 3years
Duration of response (DOR)
Time frame: up to 3years
Time to response (TTR)
Time frame: up to 3years
Best oveall response (BOR)
Time frame: up to 3years
Percentage of change in the sum of tumor diameters of target lesions
Time frame: up to 3years
Maximum percent change in the sum diameters of the target lesions
Time frame: up to 3years
Time course of tumor markers
Time frame: up to 3years
Plasma ONO-4578 concentration
Time frame: up to 3years
Serum ONO-4538 concentration
Time frame: up to 3years
Anti-ONO-4538 antibody
Time frame: up to 3years