ONO-4538-126:phase II study to ONO-4538 in patients with rhabdoid tumor

JRCT ID: jRCT2051240150

Registered date:07/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: rhabdoid tumor
• Date of first enrollment: 25/11/2024
• Target sample size: 23
• 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)

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
• 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
• Secondary ID(s): NCT06622941