This is a multicenter, open-label, uncontrolled Phase I/II study to evaluate the efficacy, safety, and pharmacokinetics of ONO-4538HSC in pediatric patients with malignant solid tumors and in patients with epithelioid sarcoma, and to evaluate the tolerability in pediatric patients. The objective of this study is to explore the tolerability, safety, efficacy, and pharmacokinetics of ONO-4538HSC in patients with pediatric malignant solid tumors. The other objective is to exploratively investigate the efficacy and safety of ONO-4538HSC in patients with epithelioid sarcoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
ONO-4538HSC will be administered subcutaneously once every 4 weeks.
Chiba University Hospital
Chiba, Chiba, Japan
NOT_YET_RECRUITINGKyushu University Hospital
Fukuoka, Fukuoka, Japan
NOT_YET_RECRUITINGHiroshima University Hospital
Hiroshima, Hiroshima, Japan
NOT_YET_RECRUITINGHokkaido University Hospital
Sapporo, Hokkaido, Japan
RECRUITINGYokohama City University Hospital
Yokohama, Kanagawa, Japan
NOT_YET_RECRUITINGKyoto University Hospital
Kyoto, Kyoto, Japan
NOT_YET_RECRUITINGOsaka International Cancer Institute
Osaka, Osaka, Japan
NOT_YET_RECRUITINGShizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
NOT_YET_RECRUITINGNational Cancer Center Hospital
Chuo-ku, Tokyo, Japan
RECRUITINGAdverse events meeting protocol-defined criteria for a DLT
Cohort of Patients with Pediatric Malignant Solid Tumor
Time frame: 28 days
Serious adverse events
Cohort of Patients with Pediatric Malignant Solid Tumor
Time frame: UP to 100 days after the last dose
Adverse events
Cohort of Patients with Pediatric Malignant Solid Tumor
Time frame: UP to 100 days after the last dose
Response rate (central assessment)
Cohort of Epithelioid Sarcoma
Time frame: Through study completion, an average of 6 months
Serum concentration of nivolumab
Cohort of Patients with Pediatric Malignant Solid Tumor
Time frame: Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)
Response rate (investigator assessment)
Cohort of epithelioid sarcoma
Time frame: Through study completion, an average of 6 months
Progression-free survival (central assessment and investigator assessment)
Cohort of epithelioid sarcoma
Time frame: Through study completion, an average of 6 months
Disease control rate (central assessment and investigator assessment)
Cohort of epithelioid sarcoma
Time frame: Through study completion, an average of 6 months
Duration of response (central assessment and investigator assessment)
Cohort of epithelioid sarcoma
Time frame: Through study completion, an average of 6 months
Time to response (central assessment and investigator assessment)
Cohort of epithelioid sarcoma
Time frame: Through study completion, an average of 6 months
Best overall response (central assessment and investigator assessment)
Cohort of epithelioid sarcoma
Time frame: Through study completion, an average of 6 months
Maximum percent change from baseline in the sum of diameters of target lesions (central assessment and investigator assessment)
Cohort of epithelioid sarcoma
Time frame: Through study completion, an average of 6 months
Changes in tumor markers over time
Cohort of epithelioid sarcoma
Time frame: Through study completion, an average of 6 months
Adverse events
Cohort of epithelioid sarcoma
Time frame: UP to 100 days after the last dose
Serum concentration of nivolumab
Cohort of epithelioid sarcoma
Time frame: Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)
North America Clinical Trial Support Desk
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