rhabdoid tumor
Conditions
Interventions
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 infus
Sponsors
Hirashima Yoshinori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Objective response rate(ORR)(Central review) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Contacts
Public ContactSupport Desk JP
Ono Pharmaceutical Co.,LTD
Outcome results
None listed