Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer
NCT ID: NCT06208657
Last Updated: 2026-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
90 participants
INTERVENTIONAL
2024-07-10
2035-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A Paxalisib
Drug: Irinotecan, Drug: Temozolomide, Drug: Paxalisib. Irinotecan starting at 50mg/m2/day, intravenous, on days 1-5, 28 day cycle, 13 cycles.
Temozolomide starting at 150mg/m2/day, oral, on days 1-5, 28 day cycle, 13 cycles.
Paxalisib starting at 21mg/m2 oral, daily, 28 day cycle, 13 cycles.
Paxalisib
Paxalisib starting at 21mg/m2 oral, daily, 28 day cycle, 13 cycles.
Irinotecan (drug)
Irinotecan starting at 50mg/m2/day, intravenous, on days 1-5, 28 day cycle, 13 cycles.
Temozolomide (TMZ)
Temozolomide starting at 150mg/m2/day, oral, on days 1-5, 28 day cycle, 13 cycles.
Arm C Opdualag
Drug: Opdualag, a fixed dose combination of Nivolumab and Relatlimab Opdualag, a fixed-dose combination of Nivolumab 480mg and Relatlimab 160mg, intravenous, on day 1, 28 day cycle, 26 cycles.
Opdualag
Opdualag, a fixed-dose combination of Nivolumab 480mg and Relatlimab 160mg, intravenous, on day 1, 28 day cycle, 26 cycles
Interventions
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Paxalisib
Paxalisib starting at 21mg/m2 oral, daily, 28 day cycle, 13 cycles.
Opdualag
Opdualag, a fixed-dose combination of Nivolumab 480mg and Relatlimab 160mg, intravenous, on day 1, 28 day cycle, 26 cycles
Irinotecan (drug)
Irinotecan starting at 50mg/m2/day, intravenous, on days 1-5, 28 day cycle, 13 cycles.
Temozolomide (TMZ)
Temozolomide starting at 150mg/m2/day, oral, on days 1-5, 28 day cycle, 13 cycles.
Eligibility Criteria
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Inclusion Criteria
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
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).
0 Years
21 Years
ALL
No
Sponsors
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The Hospital for Sick Children
OTHER
Medical Research Future Fund
OTHER
Kazia Therapeutics Limited
INDUSTRY
C17 Council
OTHER
Bristol-Myers Squibb
INDUSTRY
Stand Up To Cancer
OTHER
Australian & New Zealand Children's Haematology/Oncology Group
OTHER
Responsible Party
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Principal Investigators
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David Ziegler, Prof
Role: STUDY_CHAIR
Sydney Children's Hospital - Australian Study Chair
Daniel Morgenstern, Dr
Role: STUDY_CHAIR
The Hospital for Sick Children - Canadian Study Chair
Locations
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John Hunter Children's Hospital
Newcastle, New South Wales, Australia
Sydney Children's Hospital, Randwick
Sydney, New South Wales, Australia
The Children's Hospital at Westmead
Sydney, New South Wales, Australia
Queensland Children's Hospital
Brisbane, Queensland, Australia
Women's and Children's Hospital
Adelaide, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Monash Children's Hospital
Melbourne, Victoria, Australia
The Royal Children's Hospital
Melbourne, Victoria, Australia
Perth Children's Hospital
Perth, Western Australia, Australia
Stollery Children's Hospital
Edmonton, , Canada
CHU Sainte Justine
Montreal, , Canada
Children's Hospital of Eastern Ontario
Ottawa, , Canada
The Hospital for Sick Children
Toronto, , Canada
BC Children's Hospital
Vancouver, , Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ANZCHOG2204
Identifier Type: OTHER
Identifier Source: secondary_id
OPTIMISE
Identifier Type: -
Identifier Source: org_study_id
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