JRCT ID: jRCT2051240150
Registered date:07/10/2024
ONO-4538-126:phase II study to ONO-4538 in patients with rhabdoid tumor
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | rhabdoid tumor |
Date of first enrollment | 25/11/2024 |
Target sample size | 23 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | For adults, Nivolumab (recombinant) is administered as a 240mg intravenous infusion at two-week intervals. For pediatric patients, Nivolumab (recombinant) is administered as a 3mg/kg intravenous infusion at two-week intervals. Additionally, for pediatric patients weighing 40kg or more, Nivolumab (recombinant) can also be administered as a 240mg intravenous infusion at two-week intervals. |
Outcome(s)
Primary Outcome | Efficacy Objective response rate(ORR)(Central review) |
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Secondary Outcome | Objective response rate (ORR) (site investigator assesment) Overall survival (OS) Progression free survival (PFS) Disease control rate (DCR) Duration of response (DOR) Time to response (TTR) Best overall response (BOR) Percent change from baseline in the sum of diameters of target lesions Best reduction percent change from baseline in the sum of diameters of target lesions Safety (Adverse event) |
Key inclusion & exclusion criteria
Age minimum | >= 1age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1. Gender: Not specified 2. Age (at the time of consent): 1 year or older 3. Patients who are refractory or intolerant to one or more regimens of chemotherapy for rhabdoid Tumors 4. Patients with advanced or recurrent rhabdoid Tumors not eligible for curative resection |
Exclude criteria | 1. Patients with a history of active concurrent malignancy or complications 2. Patients with spinal lesions expected to require radiation therapy or surgical intervention during the trial period 3. Patients with concomitant central nervous system disorders other than AT/RT that are inadequately controlled or may lead to discontinuation of the investigational drug |
Related Information
Primary Sponsor | Hirashima Yoshinori |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT06622941 |
Contact
Public contact | |
Name | Center Information Medical |
Address | 3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka Osaka Japan 618-8585 |
Telephone | +81-120-626-190 |
clinical_trial@ono-pharma.com | |
Affiliation | Ono Pharmaceutical Co.,LTD |
Scientific contact | |
Name | Yoshinori Hirashima |
Address | 3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka Osaka Japan 618-8585 |
Telephone | +81-120-626-190 |
clinical_trial@ono-pharma.com | |
Affiliation | Ono Pharmaceutical Co.,LTD |