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Immunotherapy drug nivolumab takes on rare childhood cancer

NCT ID NCT06622941

Disease control Sponsor: Ono Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This phase 2 trial is testing the immunotherapy drug nivolumab in 23 people aged 1 year and older with advanced or recurrent rhabdoid tumors that have not responded to chemotherapy. The goal is to see if the drug can shrink tumors and improve survival. Participants receive nivolumab every two weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nivolumab (a type of immunotherapy that helps the immune system fight cancer)
What this could lead to
If it works, this could offer a new treatment option for people with rhabdoid tumors that have not responded to chemotherapy.
What could go wrong
This is a small, early-phase trial with only 23 participants, so results may not apply to everyone. Immunotherapy can cause side effects like inflammation in healthy organs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 23 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

rhabdoid tumor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rhabdoid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chiba University Hospital

    RECRUITING

    Chiba, Japan

  • Fukushima Medical University Hospital

    RECRUITING

    Fukushima, Japan

  • Hiroshima University Hospital

    RECRUITING

    Hiroshima, Japan

  • Hokkaido University Hospital

    RECRUITING

    Sapporo, Hokkaido, 060-8648, Japan

  • Hyogo Prefectural Kobe Children's Hospital

    RECRUITING

    Kobe, Hyōgo, Japan

  • Kanazawa University Hospital

    RECRUITING

    Kanazawa, Japan

  • Kyushu University Hospital

    NOT_YET_RECRUITING

    Fukuoka, Japan

  • Nagoya University Hospital

    RECRUITING

    Nagoya, Aichi-ken, Japan

  • National Cancer Center Hospital

    RECRUITING

    Chuo-ku, Tokyo, Japan

  • National Center for Child Health and Development

    RECRUITING

    Tokyo, Japan

  • Niigata University Medical & Dental Hospital

    RECRUITING

    Niigata, Japan

  • Osaka City General Hospital

    RECRUITING

    Osaka, Osaka, Japan

  • Tohoku University Hospital

    RECRUITING

    Miyagi, Japan

  • University Hospital, Kyoto Prefectural University of Medicine

    RECRUITING

    Kyoto, Japan

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