Rhabdoid TumorPhase 2NCT06622941
Study to ONO-4538 in Patients With Rhabdoid Tumor
A Phase 2 study testing ONO-4538 in people with Rhabdoid Tumor, run by Ono Pharmaceutical Co., Ltd. at 14 sites in Japan.
Trial summary
Investigate the efficacy and safety of ONO-4538 for the treatment of rhabdoid Tumors Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Rhabdoid Tumor
- What is being tested?
- ONO-4538
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 14 sitesJapan
- Study dates
- 25 Nov 2024to 31 Mar 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gender: Not specified
- Age (at the time of consent): 1 year or older
- Patients who are refractory or intolerant to one or more regimens of chemotherapy for rhabdoid Tumors
- Patients with advanced or recurrent rhabdoid Tumors not eligible for curative resection
Who cannot join
- Patients with a history of active concurrent malignancy or complications
- Patients with spinal lesions expected to require radiation therapy or surgical intervention during the trial period
- Patients with concomitant central nervous system disorders other than AT/RT that are inadequately controlled or may lead to discontinuation of the investigational drug
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
North America Clinical Trial Support Desk contact
International Clinical Trial Support Desk contact
14 sites in 1 country
Japan14 sites, 14 recruiting
- Recruiting
Chiba University Hospital
Chiba
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo
- Not yet recruiting
Kyushu University Hospital
Fukuoka
- Recruiting
Fukushima Medical University Hospital
Fukushima
- Recruiting
Hiroshima University Hospital
Hiroshima
- Recruiting
Kanazawa University Hospital
Kanazawa
- Recruiting
Hyogo Prefectural Kobe Children's Hospital
Kobe, Hyōgo
- Recruiting
University Hospital, Kyoto Prefectural University of Medicine
Kyoto
- Recruiting
Tohoku University Hospital
Miyagi
- Recruiting
Nagoya University Hospital
Nagoya, Aichi-ken
- Recruiting
Niigata University Medical & Dental Hospital
Niigata
- Recruiting
Osaka City General Hospital
Osaka, Osaka
- Recruiting
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
- Recruiting
National Center for Child Health and Development
Tokyo
About this study
Official title: A Multicenter, Open-label, Uncontrolled Phase II Study to Investigate Efficacy and Safety of ONO4538 in Patients With Rhabdoid Tumor
Investigate the efficacy and safety of ONO-4538 for the treatment of rhabdoid Tumors
- Conditions
- Rhabdoid Tumor
- Being tested
- ONO-4538
- Medical subject headings
- Rhabdoid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-4538Drug
Also called Nivolumab
every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| ONO-4538 | Experimental | Not described Receives: Drug: ONO-4538 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Measured: up to 4.5 years
Secondary outcomes (9)
Objective response rate (ORR) (site investigator assesment)
Measured: up to 4.5 years
Overall survival (OS)
Measured: up to 4.5 years
Progression free survival (PFS)
Measured: up to 4.5 years
Disease control rate (DCR)
Measured: up to 4.5 years
Time to response (TTR)
Measured: up to 4.5 years
Best overall response (BOR)
Measured: up to 4.5 years
Percent change from baseline in the sum of diameters of target lesions
Measured: up to 4.5 years
Best reduction percent change from baseline in the sum of diameters of target lesions
Measured: up to 4.5 years
Incidence of Adverse Events [Safety]
Measured: Up to 30 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start25 Nov 2024
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhabdoid TumorStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622941
- Sponsor's protocol ID
- ONO-4538-126
- Other IDs
- jRCT2051240150
- Status last verified
- Aug 2026
- First submitted
- 30 Sep 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Uncontrolled Phase II Study to Investigate Efficacy and Safety of ONO4538 in Patients With Rhabdoid Tumor
- ClinicalTrials.gov ID
- NCT06622941
- Acronym / sponsor ID
- ONO-4538-126
- Conditions
- Rhabdoid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate the efficacy and safety of ONO-4538 for the treatment of rhabdoid Tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ONO-4538 | Experimental | Drug: ONO-4538 |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Gender: Not specified
- Age (at the time of consent): 1 year or older
- Patients who are refractory or intolerant to one or more regimens of chemotherapy for rhabdoid Tumors
- Patients with advanced or recurrent rhabdoid Tumors not eligible for curative resection
Key exclusion criteria (3 listed)
- Patients with a history of active concurrent malignancy or complications
- Patients with spinal lesions expected to require radiation therapy or surgical intervention during the trial period
- Patients with concomitant central nervous system disorders other than AT/RT that are inadequately controlled or may lead to discontinuation of the investigational drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-4538Also: Nivolumabevery 2 weeks | Drug | ONO-4538 |
Primary outcome
Objective response rate (ORR)
Time frame: up to 4.5 years
9 secondary outcomes
Objective response rate (ORR) (site investigator assesment)
Time frame: up to 4.5 years
Overall survival (OS)
Time frame: up to 4.5 years
Progression free survival (PFS)
Time frame: up to 4.5 years
Disease control rate (DCR)
Time frame: up to 4.5 years
Time to response (TTR)
Time frame: up to 4.5 years
Best overall response (BOR)
Time frame: up to 4.5 years
Percent change from baseline in the sum of diameters of target lesions
Time frame: up to 4.5 years
Best reduction percent change from baseline in the sum of diameters of target lesions
Time frame: up to 4.5 years
Incidence of Adverse Events [Safety]
Time frame: Up to 30 days after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
North America Clinical Trial Support Desk contact
International Clinical Trial Support Desk contact
Project Leader study director
Ono Pharmaceutical Co., Ltd.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONO-4538 in people with Rhabdoid Tumor, run by Ono Pharmaceutical Co., Ltd. at 14 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact North America Clinical Trial Support Desk (+18665877745(Toll-Free), clinical_trial@ono-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: up to 4.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.