Canadian clinical trial registry

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Study Description

This is a study of pembrolizumab (antibody against a marker called PD1) in children and adolescents who have any of the following types of cancer:

• advanced melanoma (now only open for patients age 12-18)
• advanced, relapsed or refractory cancer (except brain tumours and leukemia) that have this PD1 marker (now closed) 
• relapsed or refractory classical Hodgkin lymphoma 
• advanced relapsed or refractory cancer (except brain tumours and leukemia) that is known to be "microsatellite-instability-high (MSI-H)"
• advanced relapsed or refractory cancer (except brain tumours and leukemia) that is known to be "tumor-mutational burden-high" (TMB-H)"

Pembrolizumab is a human monoclonal antibody that binds and blocks PD-1 on tumors cells.  The PD-1 pathway is an immune system checkpoint that may be used by cancer tumour cells to help them trick the immune system (escape surveillance) and avoid being destroyed. By blocking the PD-1 pathway, pembrolizumab reactivates cells from the patient immune system to help it identify and destroy the cancer cells. It is expected to slow or stop the growth of cancer cells.

This study has two parts. Part 1 will find the recommended dose for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy of pembrolizumab therapy.

Inclusion Criteria

• Age between 6 months and <18 years  (or between 3 years and <18 years of age for participants with Hodgkin's lymphoma) 
• Locally-advanced, or metastatic cancer (except brain tumours and leukemia) that is incurable and has failed prior standard therapy, or for which no standard therapy exists, or for which no standard therapy is considered appropriate. The cancer type has to meet one of the following types described in the "study description" section.
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

Publications

Geoerger B, Kang HJ, Yalon-Oren M, Marshall LV, Vezina C, Pappo A, Laetsch TW, Petrilli AS, Ebinger M, Toporski J, Glade-Bender J, Nicholls W, Fox E, DuBois SG, Macy ME, Cohn SL, Pathiraja K, Diede SJ, Ebbinghaus S, Pinto N. Pembrolizumab in paediatric patients with advanced melanoma or a PD-L1-positive, advanced, relapsed, or refractory solid tumour or lymphoma (KEYNOTE-051): interim analysis of an open-label, single-arm, phase 1-2 trial. Lancet Oncol. 2020 Jan;21(1):121-133. doi: 10.1016/S1470-2045(19)30671-0. Epub 2019 Dec 4.

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Study Description

Diffuse Intrinsic Pontine Glioma (DIPG) is an aggressive brain tumour with no effective treatment and no chance of long-term survival . When this brain tumour grows back after the initial radiation therapy, it is known as progressive or recurrent DIPG.

This study will investigate how long a second treatment with radiation (re-irradiation) keeps progressive or recurrent DIPG from growing again and the overall survival of these patients. All children enrolled will be treated with re-irradiation.

Inclusion Criteria

• The patient is 17 years of age or younger at the time of first or second relapse or progression of disease
• The patient has no evidence of metastases on MRI of the brain and the spine
• The patient has received radiation in the past, given to a total dose of <60 Gy
• At least 180 days (6 months) have elapsed from the last day of primary radiation
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

The purpose of this study is to determine whether the combination of two drugs called nivolumab and brentuximab vedotin is safe and effective in treating patients with Hodgkin's lymphoma that has come back or not responded to current therapy. 

Brentuximab vedotin is an antibody that specifically targets the CD30 marker of the Hodgkin Lymphoma cells and is able to kill them.

Nivolumab is a human monoclonal antibody that binds and blocks PD-1 on tumors cells.  The PD-1 pathway is an immune system checkpoint that may be used by cancer tumour cells to help them trick the immune system (escape surveillance) and avoid being destroyed. By blocking the PD-1 pathway, nivolumab reactivates cells from the patient's immune system to help it identify and destroy the cancer cells. It is expected to slow or stop the growth of cancer cells.

Inclusion Criteria

Child aged 5 to 18 with Hodgkin lymphoma who has already received treatment and either had no response (refractory) or experienced relapse.

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This is a phase 2 study designed to evaluate the safety of a drug called Lutathera in patients 12 to <18 years old with GEP-NET and PPGL disease. For patients on the study, this drug will be infused 4 times at 8-week intervals. After the infusions are complete, a follow-up period will take place after the last dose for each patient who received at least one dose of Lutathera.

Inclusion Criteria

• Patients must have a diagnosis of GEP-NET or PPGL that has gotten worse or can not be operated on
• Patients must be between 12 to <18 years old at the time of enrollment
• Patients must be up and about for over half of their waking hours
• Patients and their families (as applicable) must agree to sign the written informed consent forms outlined by the study team

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team. 

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Study Description

Our immune system has the ability to recognize and destroy cancer cells. Under certain circumstances (eg. mutation) these cancer cells are no longer destroyed. Immunotherapy is a treatment which aims to "mobilize" the patient's immune defenses against his disease, by restoring the ability of the immune system to act against cancer cells.Talimogen laherparepvec is a product that stimulates the production of cells specialized in destroying cancer cells after being injected directly into the tumor.

The objective of this study is to evaluate the positive and negative effects induced by the injection of this new treatment. To do this, initially, children with any type of solid tumors will receive injections of dose recalculated from the dose already known for treatment of adults.Then depending on the results, the doses are gradually reduced. The effectiveness of this treatment and the analysis of its side effects will be evaluated by observing the disease's evolution, the side effects and the duration of its effects.

Inclusion Criteria

• Children 2 to 20 years old with a recurrent solid tumor
• Subject must be a candidate for intralesional injection, defined as one or more of the following:
  • at least 1 injectable lesion ≥ 10 mm in longest diameter
  • multiple injectable lesions that in aggregate have a longest diameter of ≥ 10 mm

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This is a study of trametinib (an oral drug called a MEK inhibitor) in children and adolescents who have any of the following types of cancer or tumours:

- patients with neurofibromatosis type 1 (NF1) that have low grade glioma, or
- patients with neurofibromatosis type 1 (NF1) that have plexiform neurofibroma,
- patients with low grade glioma that has a gene change called a BRAF fusion (in the tumour)
- patients with glioma of any grade (low or high) with activation of proteins called the MAPK/ERK pathway.

For all patients (except for those with plexiform neurofibroma), the disease must have recurred or grown in size after a first treatment.

Inclusion Criteria

• Patient must be aged ≥ 1 month (corrected age) to ≤ 25 years at the time of study enrollment
• Participants must belong to one of the groups described in the study description section
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

Publications

Perreault S, Larouche V, Tabori U, Hawkin C, Lippé S, Ellezam B, Décarie JC, Théoret Y, Métras MÉ, Sultan S, Cantin É, Routhier MÈ, Caru M, Legault G, Bouffet É, Lafay-Cousin L, Hukin J, Erker C, Jabado N. A phase 2 study of trametinib for patients with pediatric glioma or plexiform neurofibroma with refractory tumor and activation of the MAPK/ERK pathway: TRAM-01. BMC Cancer. 2019 Dec 27;19(1):1250. doi: 10.1186/s12885-019-6442-2.

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Study Description

This clinical trial studies the side effects and how well entrectinib (a medication taken by mouth) works in treating patients with solid tumors and brain tumours with a specific gene change called a "NTRK fusion" or a "ROS1 fusion". Entrectinib may stop the growth of cancer cells with NTRK or ROS1 fusions by blocking the TRK or ROS1 enzymes needed for cell growth.

Inclusion Criteria

• Age up to 18 years
• Solid tumors and brain tumours with a change in a called a NTRK1/2/3 fusion or a ROS1 fusion
• Cancer that has come back (relapse) or is not improving despite treatment (progression)
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

Publications

Doebele RC, Drilon A, Paz-Ares L, Siena S, Shaw AT, Farago AF, Blakely CM, Seto T, Cho BC, Tosi D, Besse B, Chawla SP, Bazhenova L, Krauss JC, Chae YK, Barve M, Garrido-Laguna I, Liu SV, Conkling P, John T, Fakih M, Sigal D, Loong HH, Buchschacher GL Jr, Garrido P, Nieva J, Steuer C, Overbeck TR, Bowles DW, Fox E, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Demetri GD; trial investigators. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):271-282. doi: 10.1016/S1470-2045(19)30691-6. Epub 2019 Dec 11. Erratum in: Lancet Oncol. 2020 Feb;21(2):e70. Lancet Oncol. 2020 Jul;21(7):e341. Lancet Oncol. 2020 Aug;21(8):e372.

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Study Description

This is a phase 1/2 study that studies the drug avapritinib in patients 2-17 years old with solid tumors that have come back (relapsed) or have not responded to previous treatment (refractory). The tumor must have a certain genetic mutation (in KIT, PDGFRA or H3K27M (glioma only)) to qualify you for the study. The study consists of 2 parts; in part 1, more information will be gathered about the drug's safety and how it moves through the body (pharmacokinetics or PK) and in part 2, the effectiveness, safety and PK will continued to be monitored at the recommended dose. 

Inclusion Criteria

• Patients must be between 2-17 years old
• Patients must have a diagnosed solid or central nervous system (CNS) tumor that has progressed despite prior standard therapy or no alternative treatment is available 
• Patients must be able to be up and about at least half of their waking hours (if applicable)
• Blood work must come back within acceptable ranges within 14 days of the first study dose
• Patients must not be pregnant on the trial, participants of child bearing potential must agree to use approved contraception methods
• Patients and/or their families/caregivers must sign a consent form outlining all assessments and requirements