RecruitingPhase 1Phase 2NCT06208657

Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer


Sponsor

Australian & New Zealand Children's Haematology/Oncology Group

Enrollment

90 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A companion platform trial to test novel targeted agents based on the patient's tumor profile.


Eligibility

Min Age: 0 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study matches children and young adults with difficult-to-treat cancers to personalized therapies based on their tumor's genetic profile. It is an "umbrella" trial offering multiple targeted treatments depending on each patient's specific cancer mutations. **You may be eligible if...** - You are under 21 years old (or have a pediatric-type cancer if slightly older, with approval) - You have a solid tumor, brain tumor, or lymphoma that has progressed despite standard treatment, or for which no standard treatment exists - You are enrolled in a precision medicine genomic study (such as PROFYLE or ZERO) **You may NOT be eligible if...** - You have not undergone genomic testing as part of a qualifying precision medicine program - You are too unwell to tolerate treatment - Your cancer type does not match any available treatment arms in the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPaxalisib

Paxalisib starting at 21mg/m2 oral, daily, 28 day cycle, 13 cycles.

DRUGOpdualag

Opdualag, a fixed-dose combination of Nivolumab 480mg and Relatlimab 160mg, intravenous, on day 1, 28 day cycle, 26 cycles

DRUGIrinotecan (drug)

Irinotecan starting at 50mg/m2/day, intravenous, on days 1-5, 28 day cycle, 13 cycles.

DRUGTemozolomide (TMZ)

Temozolomide starting at 150mg/m2/day, oral, on days 1-5, 28 day cycle, 13 cycles.


Locations(14)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06208657


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