Canadian clinical trial registry

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Study Description

Some cancer, called hypermutant cancer, have been shown to have multiple genetic changes  or abnormalities that block DNA repair and favor tumour development. 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 immune system to help it identify and destroy the cancer cells. It is expected to slow or stop the growth of cancer cells.

In this phase I/II study, patients will not be randomized and all enrolled on the clinical trial will receive nivolumab.  The study will evaluate the dose, safety, tolerability, effect on the cancer and other important characteristics of nivolumab.  This study includes pediatric patients with recurrent or refractory hypermutant cancer aged 12 months to 18 years, including those with  bMMRD syndrome. for which no standard therapy is available or for which the subject is not eligible for the existing therapy.

Inclusion Criteria

•    Patients must be greater than 2 months and less than 25 years of age at time of enrollment. Please note, some hospitals may not be able to treat patients above certain ages (e.g., 18 years old).
•    Recurrent or relapse paediatric cancer suspected to be hypermutant, including those exhibiting evidence of genetic or molecular alterations such as: high microsatellite instability (MSI-H) in current or previous tumour, mutation causing loss of mismatch repair gene (MLH1, MSH2, MSH6, PMS2, EPCAM or MSH3) expression, hypermutation by local sequencing in current or previous tumour, a history of CMMRD, Lynch syndrome, xeroderma pigmentosum (XP), or other established disorder affiliated with an elevated hypermutation rate, a functional mutation of polymerase genes (POLE or POLD1) in current or previous tumour, a functionally impaired RRD pathway by other means; etc. 
•    Patients must have histologic or cytologic confirmation of malignancy at the time of initial diagnosis or relapse (as specified above). Patients with multiple concurrent and/or sequential neoplasms are eligible, including CNS and haematological malignancies.
•    Patients must be able to provide tumour sample (archival or a new biopsy). If a tumour sample (including archival) is not available, a new tumour sample may be needed. Any such biopsy will not be considered a trial-related procedure.

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 evaluate the drug called BMS-986158 as a possible treatment for pediatric solid tumors, lymphoma, or brain tumors. BMS-986158 belongs to a group of drugs called "Bromodomain (BRD) and Extra-Terminal Domain (BET) inhibitors". These drugs block proteins from the BET family that are important in reading part of the DNA involved in apoptosis and cell cycle progression. It is expected to slow or stop the growth of cancer cells.

The aim of this phase I study is to evaluate the dose, safety, tolerability, antitumor activity and other pharmacologic characteristics of BMS-986158 in children with refractory or relapsed pediatric solid tumors, lymphoma, or brain tumors for which no standard therapy is available or for which the subject is not eligible for the existing therapy.

Inclusion Criteria

• Age ≤ 21 years at time of enrollment.
• All patients must be able to swallow intact capsules.

• Participants must have evaluable or measurable disease and must have disease that is relapsed or refractory and for which standard curative measures do not exist or are no longer effective.

• Disease genetic alterations: MYCN amplification or high copy number gain, translocation involving MYC or MYCN, translocation involving BRD4 or BRD3

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 1 clinical trial designed to study a drug called 23ME-00610 in children and adults with advanced solid tumors that have not responded to or gotten worse after stardard therapy, or where no further standard therapy exists. In Part A of this study, researchers are looking to find the best possible dose of 23ME-00610 (called the recommended phase 2 dose). Part B of this study will evaluate how the patients body responds to the drug 23ME-00610 and continue monitoring safety. 

Inclusion Criteria

• To enroll in Part B of the study, the patient must be  ≥ 12 years of age
• Patient must weigh at least 40kg
• Patient must have a solid tumor:
  • that has progressed after all available standard therapy
  • or for which standard therapy has been ineffective
  • or for which no standard therapy exists
• Patient is up and about for at least half of their waking hours 
• Patient must have a solid tumor that has not previously been exposed to radiation

Additional inclusion or exclusion criteria may apply and will be discussed with you by the study team 

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Study Description

This study will assess the molecular subtype (abbreviated WNT, SHH, Non-WNT, Non-SHH) of patients with medulloblastoma. Based on the subtype And other factors, patients will be assigned to a "risk group", each risk group receiving specific treatment with chemotherapy and radiation therapy.

Patients with a specific molecular subtype called Sonic Hedgehog (SHH) will be treated with a medication taken by mouth, called vismodegib in addition to standard therapy, to directly target the molecular pathway. 

Inclusion Criteria

• Patients between 3 and 22 years of age with medulloblastoma.
• Patients between 22 and 40 years with medulloblastoma of the SHH subtype are eligible.
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This study seeks to test the safety and effectiveness of the drug taken by mouth called idasanutlin when taken together with chemotherapy or other cancer drugs (venetoclax) to treat acute leukemias or solid tumors in pediatric or young adults. 

The study is divided into 3 parts. The first part of the study aims to figure out the maximum dose of idasanutlin that can be safely tolerated as well as the recommended dose of idasanutlin when used in combination with chemotherapy and other cancer drugs (venetoclax).

The second part of the study aims to test the safety and effectiveness of idasanutlin in combination with chemotherapy and other cancer drugs (venetoclax) for treating neuroblastoma, acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL).

The third part of the study further monitors patients for additional responses to idasanutlin and safety assessments.

Inclusion Criteria

• Age less than 18 years old or less than 30 years old depending on study groups
• Diagnosis of neuroblastoma, acute myeloid leukemia (AML), or acute lymphoblastic leukemia (ALL) that has worsened or come back despite the use of standard therapy.
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

In this study, researchers are trying to learn more about how safe the study medicine called Alectinib is, and how well they work for children and young people with certain solid or brain cancers where previous treatment has not worked or is not available.

Inclusion Criteria

• Patients must have a confirmed diagnosis of a brain tumour or solid tumor with a specific gene change called "ALK fusion"
• Patients must have a cancer that has come back (relapsed) or has no standard treatment available
• Patients must be 17 years old or younger to participate 
• Patients must be able to walk and do routine activities for more than half of their normal waking hours
• Patients must have a willingness to complete clinical assessments throughout the study (electronic, paper and/or interviewer methods)

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

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Study Description

PBTC-049 tests a drug called savolitinib to see how well it works in children with these tumors. This drug has not been studied in children. The hope is that this drug may be a more effective treatment for these types of brain tumors in children.

Therefore, the primary goals of the study are to:

• Determine which dose of savolitinib is safe for children
• Learn what effects (good or bad) may occur when patients take savolitinib
• Learn how the body processes savolitinib

(via: PBTC-049_Summary for patients & families_05-18-2020.pdf)

Inclusion Criteria

• Patients with confirmed medulloblastoma, high-grade glioma, DIPG brain tumors, and other brain tumor types with a specific genetic marker, which continue to grow or have come back after the prior treatment may be eligible to participate.
• Patients must be between 5-21 years of age.
• Patients must have recovered from toxicities of all prior chemotherapy, immunotherapy, radiotherapy or any other treatment modality prior to entering this study.
• Pregnant women and nursing mothers are excluded from this study
• Patients or a parent/guardian must understand and sign a written consent form to participate
• Patients and/or their families must agree to the study visit requirements outlined in the consent form

(via: PBTC-049_Summary for patients & families_05-18-2020.pdf)

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

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Study Description

Patients on this study will receive 4 doses of a vaccine called SurVaxM. While vaccines are usually thought of as ways to prevent diseases, vaccines can also be used to treat cancer. SurVaxM is designed to tell the body's immune system to look for tumor cells that express a protein called survivin and destroy them. If the body's immune system knows to destroy cells that express survivin, it may help to control tumor growth and recurrence.

Inclusion Criteria

• Participant must have one of the following tumors that has progressed or come back: 
  • Medulloblastoma
  • Glioblastoma multiforme 
  • Anaplastic astrocytoma
  • High-grade astrocytoma, NOS
  • Anaplastic oligodendroglioma
  • Anaplastic ependymoma
  • Ependymoma 
  • Diffuse Intrinsic Pontine Gliomas (DIPG)
• Participant must be ≥ 1 year of age and ≤ 21 years of age at the time of screening.
• Participant or parent/guardian must be willing to sign a consent form and complete the study related assessments.
• Participants must have recovered from all previous cancer therapies. 
• Must be up and about for around 60% of the patient's waking hours
• Participants must meet all the blood work requirements 
• You cannot be pregnant or become pregnant on this study. If you are able to have children, you must use an acceptable form of birth control. Abstinence is included. 

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