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| Diagnosis | Lymphoma, brain tumours except diffuse intrinsic pontine glioma, solid tumours | Study Status | Completed |
| Phase | I |
| Age | Child, Adult - (1 to 25 Years) | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | intravenous |
| Last Posted Update | 2024-04-10 |
| ClinicalTrials.gov # | NCT04500548 |
International Sponsor
National Cancer Institute (NCI)Principal Investigators for Canadian Sites
The Hospital for Sick Children – Dr. Daniel Morgenstern
Centres
Study Description
Testing the Combination of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) in Children, Adolescent, and Young Adult Patients With Relapsed/Refractory Cancers That Have an Increased Number of Genetic Changes, The 3CI Study
This study investigates the side effects of the combination of two immunotherapy medications called nivolumab and ipilimumab, and to see how well they work in treating children, adolescents and young adults with cancers that have come back (relapsed) or does not respond to treatment (refractory) and have an increased number of genetic changes. Immunotherapy with nivolumab and ipilimumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
This study is being done to help doctors learn if the combination of nivolumab and ipilimumab can help children, adolescents, and young adults patients live longer.
This study will have two parts
- PART I: A tissue sample from the tumour is analysed for "tumour mutation burden" level. Patients with elevated level may be eligible for Part II.
- PART II: Patients receive receive treatment with nivolumab or nivolumab and ipilimumab.
Inclusion Criteria
- Age from 12 months to 25 years
- Patient with a cancer that has come back (relapsed) or does not respond to treatment (refractory)
- All tumours can be considered except leukemia and diffuse intrinsic pontine glioma
- The tumour will be tested (part 1). It needs to to have an increased number of genetic changes for the patient to be considered for part 2
- Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team
