Study to ONO-4538 in Patients With Rhabdoid Tumor | NCT06622941

Studies
Study to ONO-4538 in Patients With Rhabdoid Tumor

NCT06622941

Sponsor

Ono Pharmaceutical Co., Ltd.

Status

Recruiting

Last Update Posted

Mar 12, 2026Actual

Enrollment

23Estimated

Phase

Phase 2

Conditions

Rhabdoid Tumor

Interventions

ONO-4538

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
jRCT2051240150	Registry Identifier	Japan Registry of Clinical Trials

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 25, 2024Actual

Primary Completion Date

Jan 31, 2029Estimated

Completion Date

Mar 31, 2030Estimated

First Submitted Date

Sep 30, 2024

First Submission Date that Met QC Criteria

Sep 30, 2024

First Posted Date

Oct 2, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2026

Last Update Posted Date

Mar 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Estimated

Label	Type	Description	Intervention Names
ONO-4538	Experimental		Drug: ONO-4538

Name	Type	Description	Arm Group Labels	Other Names
ONO-4538	Drug	every 2 weeks	ONO-4538	Nivolumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate (ORR)		up to 4.5 years

Secondary Outcomes

Measure	Description	Time Frame
Objective response rate (ORR) (site investigator assesment)		up to 4.5 years
Overall survival (OS)		up to 4.5 years
Progression free survival (PFS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
North America Clinical Trial Support Desk	Contact	+18665877745(Toll-Free)		clinical_trial@ono-pharma.com
International Clinical Trial Support Desk	Contact	+17162141777(Standard)		clinical_trial@ono-pharma.com

Overall Officials

Name	Affiliation	Role
Project Leader	Ono Pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nagoya University Hospital	Recruiting	Nagoya	Aichi-ken		Japan
Hokkaido University Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018335	Rhabdoid Tumor

Ancestor Terms

ID	Term
D018193	Neoplasms, Complex and Mixed
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077594	Nivolumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided