Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer

Sponsor
Australian & New Zealand Children's Haematology/Oncology Group
Study ID
NCT06208657
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
0 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Paxalisib — DRUG
    Paxalisib starting at 21mg/m2 oral, daily, 28 day cycle, 13 cycles.
  • Opdualag — DRUG
    Opdualag, a fixed-dose combination of Nivolumab 480mg and Relatlimab 160mg, intravenous, on day 1, 28 day cycle, 26 cycles
  • Irinotecan (drug) — DRUG
    Irinotecan starting at 50mg/m2/day, intravenous, on days 1-5, 28 day cycle, 13 cycles.
  • Temozolomide (TMZ) — DRUG
    Temozolomide starting at 150mg/m2/day, oral, on days 1-5, 28 day cycle, 13 cycles.

Study Details

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

Key Dates

Start date
Jul 10, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2035

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Number of participants treated with molecularly-targeted agents in each treatment arm. [ Time Frame: 5 Years ]

Central Contacts

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