Clinical trial · Interventional
Study to ONO-4538 in Patients With Rhabdoid Tumor
A Multicenter, Open-label, Uncontrolled Phase II Study to Investigate Efficacy and Safety of ONO4538 in Patients With Rhabdoid Tumor
NCT06622941CI-TRIAL-00120499recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Investigate the efficacy and safety of ONO-4538 for the treatment of rhabdoid Tumors
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rhabdoid Tumor | Rhabdoid Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ONO-4538 | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ONO-4538
- interventionNames
- Drug: ONO-4538
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- up to 4.5 years
Secondary outcomes (9)
- measure
- Objective response rate (ORR) (site investigator assesment)
- timeFrame
- up to 4.5 years
- measure
- Overall survival (OS)
- timeFrame
- up to 4.5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.