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| Diagnosis | Relapsed or refractory extra-cranial solid and CNS tumour | Study Status | Open |
| Phase | I/II |
| Age | 12 years and older | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Drug: Opdualag (IV) |
| Last Posted Update | 2026-03-25 |
| ClinicalTrials.gov # | NCT06208657 |
International Sponsor
Australian & New Zealand Children's Haematology/Oncology GroupPrincipal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel MorgensternCentres
Study Description
This study is eligible for STEP-1 funding. Find more information here.
This study is testing Opdualag, a medicine that combines two drugs, in children, teens, and young adults (12 years and older) whose cancers have returned or not responded to treatment. Some participants will have tumors that show high immune activity, while others will have tumors that did not respond to previous immunotherapy.
The study will look at how well Opdualag works, any side effects, and how treatment affects quality of life. Blood and tissue samples will also be collected to help researchers better understand the cancer and the immune system.
Inclusion Criteria
- Patients must be 12 years or older with cancer that has come back or didn’t respond to treatment.
- Patients have a cancer (outside or inside the brain/spine) that has come back or not responded to treatment
- There are two groups:
- Tumors with a strong immune response
- Tumors with a DNA repair problem has worsened during or after prior immunotherapy
- Patients must have measurable disease confirmed by appropriate imaging methods
- Must meet all organ function requirements
- Must be up and about at least 50% of waking hours (wheelchair allowed)
- Enough time must have passed from any previous treatment; the study team will let you know the timelines
- Patients must remain abstinent or use adequate birth control as explained by the study team
