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New hope for kids with tough cancers: precision drugs tested

NCT ID NCT06208657

Disease control Sponsor: Australian & New Zealand Children's Haematology/Oncology Group 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This trial tests whether giving children and teens with advanced solid tumors, brain tumors, or lymphomas drugs that match their tumor's genetic profile can help. About 90 participants will receive one of four drug combinations based on their tumor's molecular features. The goal is to find the right dose and see if the tumors shrink or stop growing.

What this could mean

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

Active substance
Paxalisib, Opdualag (nivolumab + relatlimab), irinotecan, temozolomide
What this could lead to
If successful, this could lead to more effective, personalized treatment options for children with hard-to-treat cancers.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply to all patients. The drugs may cause side effects or not work as hoped.

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 90 people

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

Started

Jul 2024

Expected to finish

Dec 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

0 to 21 years

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. Patients must be diagnosed with a solid tumor, CNS tumor or lymphoma that has progressed despite standard therapy, or for which no effective standard therapy exists. 2. Age \<21 years at inclusion; patients 21 years and older may be included after approval by the Study Chair if they have a pediatric type recurrent/refractory malignancy. 3. Patients must be enrolled on a precision medicine study (i.e. PROFYLE, ZERO or equivalent as agreed with Study Chair). 4. Patients enrolled in a Phase I cohort must have either evaluable or measurable disease. 5. Patients enrolled in a Phase II cohort must have measurable disease. Evaluable and measurable disease are defined by standard imaging criteria for the patient's tumor type. 6. Disease evaluations, laboratory tests, and other clinical assessments that are considered standard of care may be undertaken at the patient's local oncology treatment centre with results transferred to study site for evaluation. 7. Performance status: Karnofsky performance status (for patients \> 16 years of age) or Lansky play score (for patients ≤ 16 years of age) ≥ 50%. 8. Life expectancy ≥ 6 weeks. 9. Patients must have fully recovered from the acute toxic effects of all prior anticancer therapy and must meet the following minimum duration from prior anticancer-directed therapy prior to enrolment. 10. Adequate organ function. 11. Able to comply with scheduled follow-up and with management of toxicity. 12. Females of childbearing potential must have a negative serum or urine pregnancy test. 13. Fertile males must agree to use adequate contraception during the study and following completion of treatment. 14. Provide a signed and dated informed consent form. Exclusion Criteria: 1. Patients with symptomatic central nervous system (CNS) primary or metastatic tumours who are neurologically unstable or require increasing doses of corticosteroids or local CNS-directed therapy to control their CNS disease. Patients on stable doses of corticosteroids for at least 7 days prior to receiving study drug may be included. 2. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, or malabsorption syndrome) - only for arms that include orally administered therapeutic agents. 3. Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality), unstable ischemia, congestive heart failure within 12 months of screening. 4. Known active viral hepatitis or human immunodeficiency virus (HIV) infection or any other uncontrolled infection. 5. Major surgery within 21 days of the first dose of investigational drug. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumour biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48-hour interval must be maintained before the first dose of the investigational drug is administered. 6. Known hypersensitivity to any study drug or component of the formulation. 7. Pregnant or nursing (lactating) females. 8. Any other concomitant serious medical condition or organ dysfunction that in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the investigational drug(s).

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Conditions

The condition(s) this trial relates to.

central nervous system cancer childhood malignant neoplasm childhood neoplasm lymphoma neoplasm Recurrence refractory hematologic cancer refractory malignant neoplasm

As listed by the trial registrant

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

Childhood brain tumor Childhood cancer Childhood solid tumor Recurrent cancer Refractory cancer

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    14 sites in 2 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • BC Children's Hospital

    RECRUITING

    Vancouver, Canada

  • CHU Sainte Justine

    RECRUITING

    Montreal, Canada

  • Children's Hospital of Eastern Ontario

    NOT_YET_RECRUITING

    Ottawa, Canada

  • John Hunter Children's Hospital

    RECRUITING

    Newcastle, New South Wales, Australia

  • Monash Children's Hospital

    RECRUITING

    Melbourne, Victoria, Australia

  • Perth Children's Hospital

    RECRUITING

    Perth, Western Australia, Australia

  • Queensland Children's Hospital

    RECRUITING

    Brisbane, Queensland, Australia

  • Royal Hobart Hospital

    RECRUITING

    Hobart, Tasmania, 7000, Australia

  • Stollery Children's Hospital

    NOT_YET_RECRUITING

    Edmonton, Canada

  • Sydney Children's Hospital, Randwick

    RECRUITING

    Sydney, New South Wales, Australia

  • The Children's Hospital at Westmead

    RECRUITING

    Sydney, New South Wales, Australia

  • The Hospital for Sick Children

    RECRUITING

    Toronto, Canada

  • The Royal Children's Hospital

    RECRUITING

    Melbourne, Victoria, Australia

    Contact Email: •••••@•••••

  • Women's and Children's Hospital

    RECRUITING

    Adelaide, South Australia, Australia

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