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

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

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

Some solid tumours and some brain tumours shares common a common feature that is called "deregulation of the ErbB-pathway". Afatinib is an drug, taken by mouth, that can block proteins from the ErbB-family and could be efficient in pediatric tumours with Erb pathway deregulation. 

The aim of this study is to find the maximum tolerated dose of afatinib, and to assess its activity against tumours.

Inclusion Criteria

• Paediatric patients aged 1 year to <18 years at the time of informed consent
• Diagnosis of HGG, DIPG, low grade astrocytoma, medulloblastoma/PNET, ependymoma, neuroblastoma, RMS and tumours with ErbB deregulation
• Recurrent/refractory disease after they received at least one prior standard treatment regimen
• No effective conventional therapy exists

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

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Study Description

(Translated from summary in French available on u-link.eu for the same study)

Gliomas are the most common brain tumors in children. They are classified into two groups: low-grade gliomas common in younger people and high-grade malignant gliomas that affect older children or adolescents. Genetic studies of these tumors have made it possible to highlight specific mutations which open the opportunity to new therapeutic avenues when standard treatments have not been effective.

In this protocol a combination of two drugs is used:

• Dabrafenib blocks a cellular process necessary for cell proliferation (it is a BRAF inhibitor)
• Trametinib blocks another process necessary for cell proliferation (it is a MEK inhibitor)

This study explores the efficacy and tolerance of these two new medications taken together.

Their association is studied on the two groups of glioma as follows:

• For children with high-grade glioma who have not responded to the standard treatment, the two molecules are taken orally every day.
• For children with low-grade glioma, the children are divided into 2 groups by drawing lots (randomization):
  • The first group receives the two molecules orally every day.
  • The second group receives classical chemotherapy (vincristine and carboplatin) according to standard of care. If the disease progresses despite these treatments, patient will be able to receive the two molecules tested
• In all cases the tumour will need to have a marker called BRAF V600 for the child to be considered for this study

Inclusion Criteria

(Translated from summary in French available on u-link.eu for the same study)

• Child aged 1 to 18
• Low or high grade glioma to whom standard treatments have not produced a sufficient response or who have relapsed.
• In all cases the tumour will need to have a marker called BRAF V600 for the child to be considered for this study
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

This study is to assess the effectiveness of a chemotherapy called azacitidine in addition to the standard chemotherapy in infants diagnosed with acute lymphoblastic leukemia with a certain mutation called KMT2A-rearrangement.

Enrolled patients will receive four courses of azacitidine during their treatment. The study also looks at the side effects associated with these medications.

Inclusion Criteria

• Children less than 1 year of age
• New diagnosis of acute lymphoblastic leukemia
• Presence of a change called "KMT2A-rearrangement" in the leukemia cells

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