A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ONO-4538HSC.
- Who it may be relevant to
- Registry conditions: Pediatric Malignant Solid Tumor and Epithelioid Sarcoma. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
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.
Interventions
- Drug ONO-4538HSC
ONO-4538HSC will be administered subcutaneously once every 4 weeks.
Primary outcome measures
- Adverse events meeting protocol-defined criteria for a DLT [Time frame: 28 days]
- Serious adverse events [Time frame: UP to 100 days after the last dose]
- Adverse events [Time frame: UP to 100 days after the last dose]
- Response rate (central assessment) [Time frame: Through study completion, an average of 6 months]
Secondary outcome measures (11)
- Serum concentration of nivolumab [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) [Time frame: Through study completion, an average of 6 months]
- Progression-free survival (central assessment and investigator assessment) [Time frame: Through study completion, an average of 6 months]
- Disease control rate (central assessment and investigator assessment) [Time frame: Through study completion, an average of 6 months]
- Duration of response (central assessment and investigator assessment) [Time frame: Through study completion, an average of 6 months]
- Time to response (central assessment and investigator assessment) [Time frame: Through study completion, an average of 6 months]
- Best overall response (central assessment and investigator assessment) [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) [Time frame: Through study completion, an average of 6 months]
- Changes in tumor markers over time [Time frame: Through study completion, an average of 6 months]
- Adverse events [Time frame: UP to 100 days after the last dose]
- Serum concentration of nivolumab [Time frame: Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)]
Eligibility criteria
Inclusion criteria
\[Cohort of pediatric malignant solid tumor Tolerability evaluation part\]
- Patients aged ≥ 12 to < 18 years at the time of signing the informed consent form (ICF)
- Patients with radically/curatively unresectable advanced or metastatic solid tumor who are refractory to or intolerant to standard treatment or for which no standard treatment is available.
- Patients with ECOG PS of 0 to 1
\[Cohort of pediatric malignant solid tumor Expansion part\]
- Patients aged ≥ 12 to < 18 years at the time of signing the informed consent form (ICF)
- Patients with unresectable tumors for whom nivolumab intravenous monotherapy is indicated in adults according to the package insert
- Patients who have at least 1 measurable lesion per RECIST guideline
- Patients with ECOG PS of 0 to 2
\[Cohort of Epithelioid Sarcoma\]
- Patients aged ≥ 12 years of age at the time of signing the informed consent form (ICF). However, patients aged ≥ 12 to < 18 years may be enrolled after tolerability is confirmed in the tolerability evaluation part in the cohort of pediatric malignant solid tumor.
- Patients who are refractory to or ineligible to at least 1 regimen of chemotherapy including doxorubicin for unresectable advanced or recurrent epithelioid sarcoma
- Patients who have at least 1 measurable lesion per RECIST guideline
- Patients with ECOG PS of 0 to 2
\[Common\]
- Life expectancy ≥ 3 months at the time of enrollment
Exclusion criteria
- Patients with current or previous severe hypersensitivity reactions to antibody products
- Patients with primary central nervous system tumor
- Patients with brain or meningeal metastases. However, patients who are asymptomatic and do not require treatment can be enrolled.
- Patients with multiple cancers
- Patients who have previously received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody, or other therapeutic antibodies or pharmacotherapies for regulation of T cells
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 3 centers
- Yokohama City University Hospital — Yokohama
- Osaka International Cancer Institute — Osaka
- National Cancer Center Hospital — Chuo-ku
Identifiers
NCT: NCT07734116 · ONO-4538HSC-04