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Trial Title:
Phase II Study to ONO-4538 in Patients With Rhabdoid Tumor
NCT ID:
NCT06622941
Condition:
Rhabdoid Tumor
Conditions: Official terms:
Rhabdoid Tumor
Nivolumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ONO-4538
Description:
every 2 weeks
Arm group label:
ONO-4538
Other name:
Nivolumab
Summary:
Investigate the efficacy and safety of ONO-4538 for the treatment of rhabdoid Tumors
Criteria for eligibility:
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:
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
Gender:
All
Minimum age:
1 Year
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo-ku
Country:
Japan
Facility:
Name:
Osaka City General Hospital
Address:
City:
Osaka
Country:
Japan
Start date:
September 30, 2024
Completion date:
March 31, 2030
Lead sponsor:
Agency:
Ono Pharmaceutical Co. Ltd
Agency class:
Industry
Source:
Ono Pharmaceutical Co. Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06622941
