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Recruiting

NCT Number: NCT06622941

Study to ONO-4538 in Patients With Rhabdoid Tumor

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

Recruiting

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Key information

Conditions

Rhabdoid Tumor Neoplasms Neoplasms by Histologic Type Neoplasms, Complex and Mixed

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nagoya University Hospital, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-4538

Drug

every 2 weeks

Other names: Nivolumab

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: up to 4.5 years

Secondary outcomes

  1. Objective response rate (ORR) (site investigator assesment)

    Time frame: up to 4.5 years

  2. Overall survival (OS)

    Time frame: up to 4.5 years

  3. Progression free survival (PFS)

    Time frame: up to 4.5 years

  4. Disease control rate (DCR)

    Time frame: up to 4.5 years

  5. Time to response (TTR)

    Time frame: up to 4.5 years

  6. Best overall response (BOR)

    Time frame: up to 4.5 years

  7. Percent change from baseline in the sum of diameters of target lesions

    Time frame: up to 4.5 years

  8. Best reduction percent change from baseline in the sum of diameters of target lesions

    Time frame: up to 4.5 years

  9. Incidence of Adverse Events [Safety]

    Time frame: Up to 30 days after the last dose

Study contacts

Contact information is provided by the study sponsor or research team.

International Clinical Trial Support Desk

CONTACT

[email protected]

+17162141777(Standard)

North America Clinical Trial Support Desk

CONTACT

[email protected]

+18665877745(Toll-Free)

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Open-label, Uncontrolled Phase II Study to Investigate Efficacy and Safety of ONO4538 in Patients With Rhabdoid Tumor

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Oct 2, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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