NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedrhabdoid tumor
Date of first enrollment25/11/2024
Target sample size23
Countries of recruitment
Study typeInterventional
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 OutcomeEfficacy Objective response rate(ORR)(Central review)
Secondary OutcomeObjective 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 maximumNot applicable
GenderBoth
Include criteria1. 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 criteria1. 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

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
E-mail 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
E-mail clinical_trial@ono-pharma.com
Affiliation Ono Pharmaceutical Co.,LTD