Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer

Summary

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

Conditions

• Childhood Cancer
• Childhood Solid Tumor
• Childhood Brain Tumor
• Recurrent Cancer
• Refractory Cancer

Interventions

DRUG

Paxalisib

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

DRUG

Opdualag

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

DRUG

Irinotecan (drug)

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

DRUG

Temozolomide (TMZ)

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

Sponsors & Collaborators

• The Hospital for Sick Children

  collaborator OTHER

• Medical Research Future Fund

  collaborator OTHER

• Kazia Therapeutics Limited

  collaborator INDUSTRY

• C17 Council

  collaborator OTHER

• Bristol-Myers Squibb

  collaborator INDUSTRY

• Stand Up To Cancer

  collaborator OTHER

• Australian & New Zealand Children's Haematology/Oncology Group

  lead OTHER

Principal Investigators

• David Ziegler, Prof · Sydney Children's Hospital - Australian Study Chair

• Daniel Morgenstern, Dr · The Hospital for Sick Children - Canadian Study Chair

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

0 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-10

Primary Completion

2030-12-31

Completion

2035-12-31

Countries

• Australia
• Canada

Study Locations