RecruitingPhase 2

Study to ONO-4538 in Patients With Rhabdoid Tumor

Japan23 participantsStarted 2024-11-25

Plain-language summary

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

Who can participate

Age range

1 Year

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Objective response rate (ORR)

Timeframe: up to 4.5 years

Trial details

NCT IDNCT06622941

SponsorOno Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-01-31

Contact for this trial

North America Clinical Trial Support Desk

+18665877745(Toll-Free) clinical_trial@ono-pharma.com

View on ClinicalTrials.gov More Rhabdoid Tumor trials