Canadian clinical trial registry

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Study Description

This trial studies how well cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer after surgery. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy after surgery may kill more tumor cells.


Inclusion Criteria

• Patients must be newly diagnosed with hepatic malignancies (liver cancers) such as hepatoblastoma or hepatocellular carcinoma
• Patients must be under 30 years of age 
• All patients and/or their parents or legal guardians must sign a written informed consent

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Study Description

This study seeks to test the effectiveness and best dosage for 2 different combinations of drugs in treating cancers that have come back (recurring) or never completely went away (refractory) after initial treatment. Participants will be randomly assigned to either Arm A or Arm B of the study which will determine the combination of drugs they receive.

In Arm A, participants will receive drugs called Onivyde and talazoparib.

In Arm B, participants will receive drugs called Onivyde and temozolomide.

Both combination of drugs (Onivyde + talazoparib or Onivyde + temozolomide) are expected to irreparably damage the DNA in cancer cells and lead to cancer cell death.

After the best dosages of the drug combinations are determined in Arm A and Arm B, then the study will move on to the next stage called “expansion arms”. These expansion arms treat more participants with the dosages determined in the earlier Arm A and Arm B.

There are 3 expansion arms in this study:

Arm A1: Participants with Ewing sarcoma that has come back (recurring) or never completely went away (refractory) will receive drugs called Onivyde and talazoparib.

Arm A2: Participants with cancers that have come back (recurring) or never completely went away (refractory), and their cancer has a problem with repairing DNA (identified by their doctor) will receive drugs called Onivyde and talozoparib.

Arm B1: Participants with cancers that have come back (recurring) or never completely went away (refractory) will receive drugs called Onivyde and temozolomide.

Inclusion Criteria

• Participants must be > 12 months and <30 years at the time of enrollment
• Diagnosed with cancers that have come back (recurring) or never completely went away (refractory)

• Female or male participant of reproductive potential must agree to use effective contraceptive methods at screening and throughout duration of study treatment.
• Female participants who have begun to menstruate must have a negative urine or serum pregnancy test and must be willing to have additional serum and urine pregnancy tests during the study
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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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

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Study Description

This study is to investigate how effective and safe the use of SPEAR™ T cells is in patients with Synovial Sarcoma or Myxoid/Round Cell Liposarcoma.

Inclusion Criteria

• Age ≥16 (10 years at selected sites) and <=75 years
• Diagnosis of advanced synovial sarcoma or myxoid liposarcoma / myxoid round cell liposarcoma with the appropriate genetic marker
• Measurable disease
• Adequate performance status (patient's level of functioning) 

Note: other protocol defined Inclusion criteria may apply and will be discussed with you by the study team.

Publications

A kinase-cGAS cascade to synthesize a therapeutic STING activator - PubMed (nih.gov)

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Study Description

The purpose of this study is to test the safety of an investigational drug called CFI-400945 alone and in combination with azacitidine.

Inclusion Criteria

• Patients must be >18 years of age
• Patients must have a qualifying diagnosis of Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) that has come back or not responded to other treatment
• Have acceptable laboratory screening results within certain limits
• Be able to carry out light daily work with little/no restriction

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

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Study Description

This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumours.

Inclusion Criteria

• Participant must be greater than or equal to 10 years of age on the day of signing informed consent.
• Participant has a diagnosis of synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCLS)
• Participant should be up and about 60% of their waking hours with minimal to no restrictions 
• Participant must meet the lab and organ function requirements prior to starting study

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

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Study Description

This research looks at how well a medicine called nirogacestat works in treating desmoid tumours or aggressive fibromatosis. At first, patients participating in the study are split into two groups randomly: one group gets nirogacestat, and the other group gets a placebo, which is a which is a substance that has no therapeutic effect and is indistinguishable from the actual drug. This part of the study is "double-blind," meaning neither the participants nor the researchers know who's getting the real medicine and who's getting the placebo. Later, when participants move to the next part of the study, called the "open-label phase," everyone gets nirogacestat. 

Inclusion Criteria

• Participants must be 18 years or older
• Must have confirmed Desmoid Tumor or Aggressive Fibromatosis that has progressed or not responded after at least one line of therapy 
• Participants must be up and about at least 50% of their daily waking hours
• Participants must meet organ function and lab criteria prior to starting on study
• Participants must sign an informed consent and agree to the study assessments and requirements

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

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Study Description

This study is trying to find out if adding a new drug (pembrolizumab) to the standard treatment for soft tissue sarcoma, makes the treatment work better. Researchers will compare two groups: one group gets the standard treatment of radiation before surgery, and the other group gets pembrolizumab with radiation before surgery, plus more pembrolizumab after surgery for a year, to see which group does better.

Inclusion Criteria

• Participant must be 12 years of age or older
• Participant must have an applicable sarcoma diagnosis in their extremity (patients with skin cancer, carcinoma or low-risk prostate cancer may also be eligible)
• Participant should be able to be up and about throughout the day with minimal restriction 
• Must meet all lab and organ function requirements within 10 days of starting on study 
• Participant or parent/caregiver must be willing to sign an informed consent and agree to the study requirements 
• If participants are able to have children, they must agree to use an effective method of birth control while on study and for 120 days after the last dose of pembrolizumab. 

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