Canadian clinical trial registry

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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

110 results found

Title
Status

 

I3Y-MC-JPCS - A Phase 1b/2 Study of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination With Temozolomide (Part B) in Pediatric and Young Adult Patients With Relapsed/Refractory Solid Tumors and Abemaciclib in Combination With Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients With Relapsed/Refractory Neuroblastoma (Part C)

Suspended

I3Y-MC-JPCS - A Phase 1b/2 Study of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination With Temozolomide (Part B) in Pediatric and Young Adult Patients With Relapsed/Refractory Solid Tumors and Abemaciclib in Combination With Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients With Relapsed/Refractory Neuroblastoma (Part C)

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DiagnosisSolid TumorStudy StatusSuspended
PhaseI/II
Ageup to 21 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationAbemaciclib (Given Orally) in combination with: Irinotecan and Temozolomide (Part A Only) Temozolomide alone (Part B Only) Dinutuximab, GM-CSF, Irinotecan, and Temozolomide (Part C Only)
Last Posted Update2024-05-02
ClinicalTrials.gov #NCT04238819
International Sponsor
Eli Lilly and Company
Principal Investigators for Canadian Sites
Ste Justine - Dr. Pierre Teira
Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

The study's purpose is to see if the drug, abemaciclib, is safe and effective when given with other drugs to kill cancer cells. The study is open to children and young adults with solid tumors, including neuroblastoma, that did not respond or grew during other anti-cancer treatment.

Inclusion Criteria
  • Participants must be ≤ 18 years of age (Part A and B only) or < 21 years of age (Part C only)
  • Must have adequate body surface area (BSA)
  • Participants must have a solid tumour (excluding lymphoma) that has come back or progressed on standard therapies
  • PART C ONLY: Participants with neuroblastoma that has come back or progressed on standard therapies
  • Participants must be able to be up and about for at least half of their waking hours
  • Participants of reproductive potential must not be pregnant within 7 days of and during the study
  • Ability to swallow
  • Participants and their families (as applicable) must agree to the study assessments by signing an informed consent form

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

PED-CITN-01 - 3CI Study: Childhood Cancer Combination Immunotherapy.

Completed

PED-CITN-01 - 3CI Study: Childhood Cancer Combination Immunotherapy.

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DiagnosisLymphoma, brain tumours except diffuse intrinsic pontine glioma, solid tumoursStudy StatusCompleted
PhaseI
AgeChild, Adult - (1 to 25 Years) RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment Administrationintravenous
Last Posted Update2024-04-10
ClinicalTrials.gov #NCT04500548
International Sponsor
National Cancer Institute (NCI)
Principal Investigators for Canadian Sites
The Hospital for Sick Children – Dr. Daniel Morgenstern


Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

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

ADP 0044-002 - A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR™ T Cells in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

Open

ADP 0044-002 - A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR™ T Cells in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

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DiagnosisSynovial Sarcoma, Myxoid Liposarcoma, Round Cell LiposarcomaStudy StatusOpen
PhaseII
Age10 Years to 75 Years RandomisationYES
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationGenetic: afamitresgene autoleucel (previously ADP-A2M4) Single infusion of autologous genetically modified afamitresgene autoleucel (previously ADP-A2M4) Dose: 1.0 x109 to 10x109 transduced by a single intravenous infusion
Last Posted Update2024-04-09
ClinicalTrials.gov #NCT04044768
International Sponsor
Adaptimmune
Principal Investigators for Canadian Sites
Princess Margaret Cancer Centre - Dr. A. Razak
Centres
Medical contact

    CNS - Dr. Julie Bennett

     julie.bennett@sickkids.ca

     Sarcoma - Dr. Abha Gupta

     abha.gupta@uhn.ca

     Leukemia & Lymphoma - Dr. Dawn Maze

     dawn.maze@uhn.ca

Social worker/patient navigator contact

Please contact medical team for further information.

Clinical research contact

     CNS Trials - On Yee Jones

     onyee.jones@uhn.ca

     Sarcoma Trials - Hagit Peretz Soroka

     hagit.peretz@uhn.ca

     Leukemia & Lymphoma Trials - Deborah Sanfelice 

     deborah.Sanfelice@uhn.ca

 

 

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)

CFI-400945-AML-201/TWT-202 - Phase 1b/2 Clinical Study of the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of CFI-400945 as a Single Agent or in Combination With Azacitidine in Patients With AML, MDS or CMML

Open

CFI-400945-AML-201/TWT-202 - Phase 1b/2 Clinical Study of the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of CFI-400945 as a Single Agent or in Combination With Azacitidine in Patients With AML, MDS or CMML

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DiagnosisAcute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML)Study StatusOpen
PhaseI/II
Age18 Years and older RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: CFI-400945 (oral) Arm 2A only: Azacitidine (IV)
Last Posted Update2024-04-09
ClinicalTrials.gov #NCT04730258
International Sponsor
Treadwell Therapeutics, Inc
Principal Investigators for Canadian Sites
Princess Margaret Cancer Centre
Centres
Medical contact

    CNS - Dr. Julie Bennett

     julie.bennett@sickkids.ca

     Sarcoma - Dr. Abha Gupta

     abha.gupta@uhn.ca

     Leukemia & Lymphoma - Dr. Dawn Maze

     dawn.maze@uhn.ca

Social worker/patient navigator contact

Please contact medical team for further information.

Clinical research contact

     CNS Trials - On Yee Jones

     onyee.jones@uhn.ca

     Sarcoma Trials - Hagit Peretz Soroka

     hagit.peretz@uhn.ca

     Leukemia & Lymphoma Trials - Deborah Sanfelice 

     deborah.Sanfelice@uhn.ca

 

 

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

IGNYTE-ESO - Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, Alone or in Combination With Other Agents, in HLA-A2+ Participants With NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO)

Closed to enrollment

IGNYTE-ESO - Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, Alone or in Combination With Other Agents, in HLA-A2+ Participants With NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO)

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DiagnosisAdvanced tumorsStudy StatusClosed to enrollment
PhaseII
Age10 Years and olderRandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDrug: Letetresgene autoleucel (lete-cel, GSK3377794) letetresgene autoleucel will be administered. Drug: Fludarabine Fludarabine will be used as the lymphodepleting chemotherapy Drug: Cyclophosphamide Cyclophosphamide will be used as the lymphodepleting chemotherapy.
Last Posted Update2024-04-09
ClinicalTrials.gov #NCT03967223
International Sponsor
GlaxoSmithKline
Principal Investigators for Canadian Sites
Maisonneuve-Rosemont Hospital
Centres
Medical contact
N/A
Social worker/patient navigator contact
N/A
Clinical research contact
N/A

 

 

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

NIR-DT-301 - A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients With Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF)

Closed to enrollment

NIR-DT-301 - A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients With Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF)

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DiagnosisDesmoid Tumor, Aggressive FibromatosisStudy StatusClosed to enrollment
PhaseIII
Age18 Years and olderRandomisationYES
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDrug: Nirogacestat 150 mg by mouth, twice daily
Last Posted Update2024-04-09
ClinicalTrials.gov #NCT03785964
International Sponsor
SpringWorks Therapeutics, Inc.
Principal Investigators for Canadian Sites
Princess Margaret Cancer Centre
McGill University Health Centre
Centres
Medical contact

Sarcoma - Dr. Jonathan Noujaim 

     jonathan.noujaim.med@ssss.gouv.qc.ca

Sarcoma  -  Dr. Ramy Saleh    

 ramy.saleh@mcgill.ca

Social worker/patient navigator contact
N/A
Clinical research contact

Sarcoma - Mahafarin Maralani

     mahafarin.maralani@muhc.mcgill.ca

Medical contact

    CNS - Dr. Julie Bennett

     julie.bennett@sickkids.ca

     Sarcoma - Dr. Abha Gupta

     abha.gupta@uhn.ca

     Leukemia & Lymphoma - Dr. Dawn Maze

     dawn.maze@uhn.ca

Social worker/patient navigator contact

Please contact medical team for further information.

Clinical research contact

     CNS Trials - On Yee Jones

     onyee.jones@uhn.ca

     Sarcoma Trials - Hagit Peretz Soroka

     hagit.peretz@uhn.ca

     Leukemia & Lymphoma Trials - Deborah Sanfelice 

     deborah.Sanfelice@uhn.ca

 

 

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. 

SU2C-SARC032 - A Phase II Randomized Controlled Trial of Neoadjuvant Pembrolizumab With Radiotherapy and Adjuvant Pembrolizumab in Patients With High-Risk, Localized Soft Tissue Sarcoma of the Extremity

Closed to enrollment

SU2C-SARC032 - A Phase II Randomized Controlled Trial of Neoadjuvant Pembrolizumab With Radiotherapy and Adjuvant Pembrolizumab in Patients With High-Risk, Localized Soft Tissue Sarcoma of the Extremity

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DiagnosisSoft Tissue SarcomaStudy StatusClosed to enrollment
PhaseII
Age≥ 12 yearsRandomisationYES
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDrug: Pembrolizumab (KEYTRUDA®) Pembrolizumab will be administered at 200 mg intravenously every 3 weeks for patients on the treatment arm. Participants not on the treatment arm will receive standard of care radiotherapy followed by surgical resection.
Last Posted Update2024-04-09
ClinicalTrials.gov #NCT03092323
International Sponsor
Sarcoma Alliance for Research through Collaboration
Principal Investigators for Canadian Sites
McGill University Health Centre - Please email research contact
Centres
Medical contact

Sarcoma - Dr. Jonathan Noujaim 

     jonathan.noujaim.med@ssss.gouv.qc.ca

Sarcoma  -  Dr. Ramy Saleh    

 ramy.saleh@mcgill.ca

Social worker/patient navigator contact
N/A
Clinical research contact

Sarcoma - Mahafarin Maralani

     mahafarin.maralani@muhc.mcgill.ca

 

 

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 

CC-96191-AML-001 - A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-96191 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

Open

CC-96191-AML-001 - A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-96191 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

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DiagnosisMyeloid LeukemiaStudy StatusOpen
PhaseI
Age18 Years and older RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationCC-96191 will be administered intravenously on a 28-day Cycle
Last Posted Update2024-04-09
ClinicalTrials.gov #NCT04789655
International Sponsor
Celgene
Principal Investigators for Canadian Sites
Princess Margaret Cancer Centre
Centres
Medical contact

    CNS - Dr. Julie Bennett

     julie.bennett@sickkids.ca

     Sarcoma - Dr. Abha Gupta

     abha.gupta@uhn.ca

     Leukemia & Lymphoma - Dr. Dawn Maze

     dawn.maze@uhn.ca

Social worker/patient navigator contact

Please contact medical team for further information.

Clinical research contact

     CNS Trials - On Yee Jones

     onyee.jones@uhn.ca

     Sarcoma Trials - Hagit Peretz Soroka

     hagit.peretz@uhn.ca

     Leukemia & Lymphoma Trials - Deborah Sanfelice 

     deborah.Sanfelice@uhn.ca

 

 

Study Description

This study will explore the safety, tolerability and efficacy of the biologic CC-96191 in acute myeloid leukemia (AML) that has come back or not responded to previous treatment. 

Inclusion Criteria
  • Patient must be 18 years or older
  • Patient must have AML that has come back (relapsed) or not responded to previous treatment
  • Patient must be willing to sign a consent form
  • Females and males must practice true abstinence or agree to approved contraceptive methods throughout the study, and during the safety follow-up period.

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