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

Investigate the efficacy and safety of ONO-4538 for the treatment of rhabdoid Tumors

Study Overview

• Status: Recruiting
• Conditions: Rhabdoid Tumor
• Intervention / Treatment: Drug: ONO-4538

• Study Type: Interventional
• Enrollment (Estimated): 23
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: North America Clinical Trial Support Desk; Phone Number: +18665877745(Toll-Free); Email: clinical_trial@ono-pharma.com
• Study Contact Backup: Name: International Clinical Trial Support Desk; Phone Number: +17162141777(Standard); Email: clinical_trial@ono-pharma.com

Study Locations

• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan
      • Recruiting
      • Nagoya University Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Recruiting
      • Hokkaido University Hospital
  • Hyōgo
    • Kobe, Hyōgo, Japan
      • Recruiting
      • Hyogo Prefectural Kobe Children's Hospital
  • Osaka
    • Osaka, Osaka, Japan
      • Recruiting
      • Osaka City General Hospital
  • Tokyo
    • Chuo-ku, Tokyo, Japan
      • Recruiting
      • National Cancer Center Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ONO-4538	Drug: ONO-4538; every 2 weeks; Other Names: Nivolumab

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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)	up to 4.5 years
Disease control rate (DCR)	up to 4.5 years
Time to response (TTR)	up to 4.5 years
Best overall response (BOR)	up to 4.5 years
Percent change from baseline in the sum of diameters of target lesions	up to 4.5 years
Best reduction percent change from baseline in the sum of diameters of target lesions	up to 4.5 years
Incidence of Adverse Events [Safety]	Up to 30 days after the last dose

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2024
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): March 31, 2030

Study Registration Dates

• First Submitted: September 30, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Complex and Mixed; Rhabdoid Tumor; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nivolumab
• Other Study ID Numbers: ONO-4538-126; jRCT2051240150 (Registry Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes