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Can a new drug shrink Hard-to-Treat childhood cancers?

NCT ID NCT07734116

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This trial is testing an experimental drug called ONO-4538HSC (nivolumab) in children with advanced solid tumors that have not responded to standard treatments, and in patients with epithelioid sarcoma. The goal is to see if the drug is safe, tolerable, and effective at shrinking tumors. Participants receive the drug as an injection under the skin every four weeks.

What this could mean

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

Active substance
an experimental drug called ONO-4538HSC (nivolumab)
What this could lead to
If effective, this could offer a new treatment option for children with hard-to-treat solid tumors and for epithelioid sarcoma.
What could go wrong
This is an early-phase trial with a small number of participants, so the drug may not prove effective or may cause significant side effects.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 50 people

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

Started

Aug 2026

Expected to finish

Feb 2032

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

12 years 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: \[Cohort of pediatric malignant solid tumor Tolerability evaluation part\] 1. Patients aged ≥ 12 to \< 18 years at the time of signing the informed consent form (ICF) 2. Patients with radically/curatively unresectable advanced or metastatic solid tumor who are refractory to or intolerant to standard treatment or for which no standard treatment is available. 3. Patients with ECOG PS of 0 to 1 \[Cohort of pediatric malignant solid tumor Expansion part\] 4. Patients aged ≥ 12 to \< 18 years at the time of signing the informed consent form (ICF) 5. Patients with unresectable tumors for whom nivolumab intravenous monotherapy is indicated in adults according to the package insert 6. Patients who have at least 1 measurable lesion per RECIST guideline 7. Patients with ECOG PS of 0 to 2 \[Cohort of Epithelioid Sarcoma\] 8. Patients aged ≥ 12 years of age at the time of signing the informed consent form (ICF). However, patients aged ≥ 12 to \< 18 years may be enrolled after tolerability is confirmed in the tolerability evaluation part in the cohort of pediatric malignant solid tumor. 9. Patients who are refractory to or ineligible to at least 1 regimen of chemotherapy including doxorubicin for unresectable advanced or recurrent epithelioid sarcoma 10. Patients who have at least 1 measurable lesion per RECIST guideline 11. Patients with ECOG PS of 0 to 2 \[Common\] 12. Life expectancy ≥ 3 months at the time of enrollment Exclusion Criteria: 1. Patients with current or previous severe hypersensitivity reactions to antibody products 2. Patients with primary central nervous system tumor 3. Patients with brain or meningeal metastases. However, patients who are asymptomatic and do not require treatment can be enrolled. 4. Patients with multiple cancers 5. Patients who have previously received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody, or other therapeutic antibodies or pharmacotherapies for regulation of T cells

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Conditions

The condition(s) this trial relates to.

childhood malignant neoplasm epithelioid sarcoma sarcoma

As listed by the trial registrant

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

Pediatric malignant solid tumor and epithelioid sarcoma

How to take part

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

  1. The places running it

    9 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

    NOT_YET_RECRUITING

    Chiba, Chiba, Japan

  • Hiroshima University Hospital

    NOT_YET_RECRUITING

    Hiroshima, Hiroshima, Japan

  • Hokkaido University Hospital

    RECRUITING

    Sapporo, Hokkaido, Japan

  • Kyoto University Hospital

    NOT_YET_RECRUITING

    Kyoto, Kyoto, Japan

  • Kyushu University Hospital

    NOT_YET_RECRUITING

    Fukuoka, Fukuoka, Japan

  • National Cancer Center Hospital

    RECRUITING

    Chuo-ku, Tokyo, Japan

  • Osaka International Cancer Institute

    NOT_YET_RECRUITING

    Osaka, Osaka, Japan

  • Shizuoka Cancer Center

    NOT_YET_RECRUITING

    Sunto-gun, Shizuoka, Japan

  • Yokohama City University Hospital

    NOT_YET_RECRUITING

    Yokohama, Kanagawa, Japan

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