Study to ONO-4538 in Patients With Rhabdoid Tumor

NCT06622941 | Recruiting Phase 2

• 2 other identifiers: ONO-4538-126jRCT2051240150
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Rhabdoid Tumor

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  up to 4.5 years

Secondary Outcomes (9)

• 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

Study Arms (1)

ONO-4538

EXPERIMENTAL

Drug: ONO-4538

Interventions

ONO-4538 DRUG

every 2 weeks

Also known as: Nivolumab

ONO-4538

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (5)

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

RECRUITING

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

RECRUITING

Hyogo Prefectural Kobe Children's Hospital

Kobe, Hyōgo, Japan

RECRUITING

Osaka City General Hospital

Osaka, Osaka, Japan

RECRUITING

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

RECRUITING

MeSH Terms

Conditions

Rhabdoid Tumor

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Project Leader

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): March 31, 2030
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (5)