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.

85 results found

Title
Status

 

HeadStart4 (IRB15-00399) - HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Randomization to Either Single Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy With Autologous Hematopoietic Progenitor Cell Rescue

Closed to enrollment

HeadStart4 (IRB15-00399) - HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Randomization to Either Single Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy With Autologous Hematopoietic Progenitor Cell Rescue

Go to Health Care Provider version

DiagnosisMedulloblastoma, Central Nervous System Embryonal Tumors, Pineoblastoma, CNS neuroblastoma, CNS ganglioneuroblastomaStudy StatusClosed to enrollment
PhaseIV
AgeChild - (up to 10 years)RandomisationYES
Line of treatmentFirst line treatment
Routes of Treatment AdministrationIV chemotherapies
Last Posted Update2024-05-02
ClinicalTrials.gov #NCT02875314
International Sponsor
Nationwide Children's Hospital
Principal Investigators for Canadian Sites
BC Children's Hospital – Dr. Sylvia Cheng
Alberta Children's Hospital – Dr. Lucie Lafay-Cousin
The Hospital for Sick Children – Dr. Annie A. Huang
Stollery Children's Hospital – Dr. Bev Wilson
Hamilton Health Sciences Centre, McMaster University – Dr. Adam Fleming

Centres
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
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

 

Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai

 

 

Social worker/patient navigator contact
Danielle Sikora
 Michelle Woytiuk 
Jaime Hobbs
Clinical research contact
Amanda Perreault
Medical contact
Dr. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 

 

 

Study Description

This study looks to assess if additional intensive treatment for patients with medulloblastoma and other embryonal brain tumors improves outcomes without adding significant short or long-term side effects. 

Inclusion Criteria

Patients 10 years of age of less with a diagnosis of medulloblastoma or CNS embryonal tumors of the brain or spinal cord. Any stage of medulloblastoma or CNS embryonal tumor in children less than 6 years old are eligible, whereas only high risk patients from 6-10 years of age are eligible. 

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

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)

Go to Health Care Provider version

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

CONNECT1903 - A Pilot and Surgical Study of Larotrectinib for Treatment of Children with Newly-Diagnosed High-Grade Glioma with NTRK Fusion

Open

CONNECT1903 - A Pilot and Surgical Study of Larotrectinib for Treatment of Children with Newly-Diagnosed High-Grade Glioma with NTRK Fusion

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DiagnosisHigh Grade Glioma Study StatusOpen
PhaseII
AgeChild, Adult - (up to 21 Years) RandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationOral
Last Posted Update2024-05-01
ClinicalTrials.gov #NCT04655404
International Sponsor
Nationwide Children's Hospital
Principal Investigators for Canadian Sites
Montreal Children’s Hospital – Dr. Geneviève Legault
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

 

Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 

 

 

Study Description

(As seen on the Australian & New Zealand Childrens Haematology/Oncology Group website - https://anzchog.org/clinic-trails/connect-1903-a-pilot-and-surgical-study-of-larotrectinib-for-treatment-of-children-with-newly-diagnosed-high-grade-glioma-with-ntrk-fusion/ )

Recent research shows that a new oral tablet drug, larotrectinib, has produced promising results by shrinking some solid tumours that have an abnormal or mutated NTRK gene in adults and children.

High grade gliomas (HGG) are fast growing, aggressive brain cancers and if they recur after initial treatment, there are no effective treatment options. This study will investigate if larotrectinib alone as well as Larotrectinib  in combination with chemotherapy or radiotherapy can  be of benefit in children with high grade gliomas with the mutated NTRK gene. This international trial will study how well the drug is tolerated and its effectiveness to shrink these tumours when used alone or when given with standard chemotherapy or after radiation.

Inclusion Criteria

(As seen on the Australian & New Zealand Childrens Haematology/Oncology Group website - https://anzchog.org/clinic-trails/connect-1903-a-pilot-and-surgical-study-of-larotrectinib-for-treatment-of-children-with-newly-diagnosed-high-grade-glioma-with-ntrk-fusion/ )

  • Patient must be 21 years old or younger and newly diagnosed with high grade glioma (HGG)
  • The tumour must have a genetic anomaly called an NTRK fusion for the patient to qualify
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

AREN1921 - Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Open

AREN1921 - Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Go to Health Care Provider version

DiagnosisAnaplastic Wilms Tumor, Recurrent Wilms TumorStudy StatusOpen
PhaseII
Ageup to 30 YearsRandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationChemotherapy medications, all given intravenously (Carboplatin, Cyclophosphamide, Doxorubicin, Etoposide, Ifosfamide, Irinotecan, Topotecan, Vincristine)
Last Posted Update2024-04-30
ClinicalTrials.gov #NCT04322318
International Sponsor
Children's Oncology Group
Principal Investigators for Canadian Sites
Alberta Children's Hospital - Dr. Victor Lewis
BC Children's Hospital - Dr. David Dix
CancerCare Manitoba - Dr. Ashley Chopek
McMaster Children's Hospital - Dr. Uma Athale
Stollery Children's Hospital - Dr. Sarah McKillop
Western Children's Hospital - Dr. Shayna Zelcer
Children's Hospital of Eastern Ontario (CHEO) - Dr. Donna Johnston
Hospital for Sick Children - Dr. Daniel Morgenstern
Montreal Children's Hospital - Dr. Sharon Abish
CHU Quebec - Dr. Bruno Michon
CHU Ste. Justine - Dr. Yvan Samson
IWK Health Centre - Dr. Craig Erker
Janeway Hospital - Dr. Lisa Goodyear
CHU Sherbrooke - Dr. Josée Brossard
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

 

Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

Medical contact
Dr. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
 
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson

 

 

Medical contact
Dr. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 
Medical contact
Dr. Donna Johnston
Dr. Lesleigh Abbott
Dr. Doaa Abdel Fattah
 
Social worker/patient navigator contact
Sherley Telisma
 
Clinical research contact
Carol Duchenne
 
Medical contact
Dr. Alexandra Zorzi
Dr. Shayna Zelcer
 
Social worker/patient navigator contact
Cindy Milne Wren
Jessica Mackenzie Harris
 
Clinical research contact
Mariam Mikhail
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai

 

 

Social worker/patient navigator contact
Danielle Sikora
 Michelle Woytiuk 
Jaime Hobbs
Clinical research contact
Amanda Perreault
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
 
Medical contact
Dr. Paul Moorehead
 
Social worker/patient navigator contact
Stephanie Eason
 
Clinical research contact
Bev Mitchell
 
Medical contact
Dr. Josee Brossard 
Social worker/patient navigator contact
Please Contact Site Directly
 
Clinical research contact
Please Contact Site Directly 
 

 

 

Study Description

In this study, researchers want to find out if

  • they can improve treatment for participants with newly diagnosed diffuse anaplastic Wilms tumour (DAWT). In hopes of finding a better therapy to fight against the cancer, participants will be given chemotherapy drugs and radiation therapy in this study. The chemotherapy drugs that participants will be receiving are often given to fight against cancer and together, the treatment is known as Regimen UH-3. This study looks at how well Regimen UH-3 works when given to children and young adults with newly diagnosed DAWT.
  • they can improve treatment for participants with "standard risk" favourable histogy Wilms tumour (FWHT) that has come back (relapsed). In hopes of finding a better therapy to fight against the cancer, participants will be given chemotherapy drugs and radiation therapy in this study. The chemotherapy drugs that participants will be receiving are often given to fight against cancer and together, the treatment is known as Regimen UH-3. This study looks at how well Regimen UH-3 works when given to children and young adults with "standard risk" favourable histogy Wilms tumour (FWHT) that has come back (relapsed).
  • they can improve treatment for participants with "high-risk or very high-risk" favourable histogy Wilms tumour (FWHT) that has come back (relapsed). In hopes of finding a better therapy to fight against the cancer you have, participants will be given chemotherapy drugs and radiation therapy in this study. The chemotherapy drugs that participants will be receiving are often given to fight cancer and together, the regimen is known as Regimen ICE/Cyclo/Topo. This study looks at how well this regimen works when given to children and young adults with "high-risk or very high-risk" favourable histogy Wilms tumour (FWHT) that has come back (relapsed).

Drugs used in chemotherapy regimens 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.

 

Inclusion Criteria
  • Age less than 30 years
  • New diagnosis of diffuse anaplastic Wilms tumour
  • OR a diagnosis of Wilms tumour at first relapse (tumour that has come back, and must have been "favourable histology" at initial diagnosis)
  • Patient must be capable of all self care - such that they are out of bed >50% of day
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

AHEP1531 - Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

Open

AHEP1531 - Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

Go to Health Care Provider version

DiagnosisHepatocellular Carcinoma, Malignant Liver Neoplasm, Fibrolamellar Carcinoma, Hepatoblastoma Study StatusOpen
PhaseII/III
AgeChild, Adult - (up to 30 Years)RandomisationYES
Line of treatmentFirst line treatment
Routes of Treatment AdministrationCisplatin: IV, Other drugs are given as usually administered for hepatoblastoma/liver cancer therapy
Last Posted Update2024-04-30
ClinicalTrials.gov #NCT03533582
International Sponsor
Children's Oncology Group
Principal Investigators for Canadian Sites
Alberta Children's Hospital - Dr. Victor A. Lewis
University of Alberta Hospital (Not Affiliated with U-Link) - Dr. Sarah J. McKillop
CancerCare Manitoba - Dr. Ashley Chopek
IWK Health Centre - Dr. Craig Erker
Hamilton Health Sciences Centre, McMaster University - Dr. Uma H. Athale
Cancer Centre of Southeastern Ontario at Kingston General Hospital - Dr. Laura Wheaton
Children's Hospital of Western Ontario - Dr. Shayna M. Zelcer
The Hospital for Sick Children - Dr. Furqan Shaikh
Montreal Children's Hospital - Dr. Sharon B. Abish
CHU Ste-Justine - Dr. Yvan Samson
CHU de Quebec - Dr. Bruno Michon
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Dr. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
 
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson

 

 

Medical contact
Dr. Craig Erker
Dr. Conrad Fernandez 
Dr. Ketan Kulkarni 
 
Social worker/patient navigator contact
Rhonda Brophy
 
Clinical research contact
Tina Bocking
 
Medical contact
Dr. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 
Medical contact
Dr. Laura Wheaton
Dr. Mariana Silva
 
Social worker/patient navigator contact
Jessica Amey
 
Clinical research contact
Heather McLean
 
Medical contact
Dr. Alexandra Zorzi
Dr. Shayna Zelcer
 
Social worker/patient navigator contact
Cindy Milne Wren
Jessica Mackenzie Harris
 
Clinical research contact
Mariam Mikhail
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

 

Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
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
 
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

 

 

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

BO41932 (TAPISTRY) - Tumor-Agnostic Precision Immunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

Open

BO41932 (TAPISTRY) - Tumor-Agnostic Precision Immunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

Go to Health Care Provider version

DiagnosisSolid tumors with eligible genetic changeStudy StatusOpen
PhaseII
AgeChild (Under 18 Years)RandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationEntrectinib - oral Atezolizumab - IV Ipatasertib - oral Alectinib - oral Trastuzumab - IV GDC-0077 (Inavolisib) - oral Belvarafenib - oral Pralsetinib - oral
Last Posted Update2024-04-29
ClinicalTrials.gov #NCT04589845
International Sponsor
Hoffmann-La Roche
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

(from https://forpatients.roche.com/en/trials/cancer/solid-tumors/tumor-agnostic-precision-immuno-oncology-and-somatic-ta-50851.html)

This clinical trial is recruiting people who have advanced solid tumors that cannot be surgically removed. You (or your child) must have had genetic testing on the solid tumors that shows a positive result for one of the genetic changes, also known as biomarkers, being tested in this trial.

The purpose of this clinical trial is to compare the effects, good or bad, of different targeted therapies and immunotherapies in patients with solid tumors that cannot be surgically removed and show specific biomarkers.

To be able to take part in this clinical trial, you (or your child) must have been diagnosed with solid tumors that cannot be surgically removed and show one of the specific biomarkers that are being tested in this study:

  • ROS1 fusion-positive tumors
  • NTRK1/2/3 fusion-positive tumors
  • TMB-high tumors
  • ALK fusion-positive
  • AKT1/2/3 mutant-positive tumors
  • HER2 mutant-positive tumors
  • PIK3CA multiple mutant-positive tumors
  • BRAF class II mutant or fusion-positive tumors
  • BRAF class III mutant-positive tumors
  • RET fusion-positive tumors

Your doctor will be able to give you more information on the type of biomarker your solid tumors show. You must be otherwise in good health to take part. You will not be able to take part if you are pregnant or breastfeeding, or if you have received any recent treatment for your cancer. Some of the groups may have other specific requirements. Your doctor will be able to give you more information on this.

Inclusion Criteria
  • Less than 18 years of age for cohort E and K
  • Age between 12 and 17 years for cohorts E, F and H
  • Diagnosis of advanced cancer that has spread to a different part of the body (metastasized) and can’t be removed by an operation (unresectable)
  • Participants must be up and about at least 50% of their waking hours
  • The cancer must have a specific genetic change in one of the following genes: ROS1, NTRK1/2/3, AKT, PIK3CA, HER2, BRAF, RET, or be TMB-high

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

ONITT - A Randomized Phase I/II Study of Talazoparib or Temozolomide in Combination With Onivyde in Children With Recurrent Solid Malignancies and Ewing Sarcoma

Closed to enrollment

ONITT - A Randomized Phase I/II Study of Talazoparib or Temozolomide in Combination With Onivyde in Children With Recurrent Solid Malignancies and Ewing Sarcoma

Go to Health Care Provider version

DiagnosisEwing Sarcoma, Hepatoblastoma, Neuroblastoma, Osteosarcoma, Rhabdoid Tumor, Rhabdomyosarcoma, Wilms, SarcomaStudy StatusClosed to enrollment
PhaseI/II
AgeChild, Adult - (12 Months to 30 Years) RandomisationYES
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationOnivyde: IV , Talazoparib: oral , Temozolomide: unspecified (oral or IV most likely)
Last Posted Update2024-04-26
ClinicalTrials.gov #NCT04901702
International Sponsor
St. Jude Children's Research Hospital
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
BC Children's Hospital - Dr. Rebecca Deyell
CHU Ste Justine - Dr Monia Marzouki
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

 

Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

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

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

PEPN2121 - A Phase 1/2 Study of Tiragolumab (NSC# 827799) and Atezolizumab (NSC# 783608) in Patients With Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors

Open

PEPN2121 - A Phase 1/2 Study of Tiragolumab (NSC# 827799) and Atezolizumab (NSC# 783608) in Patients With Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors

Go to Health Care Provider version

DiagnosisRecurrent/Refractory Atypical Teratoid/Rhabdoid Tumor, Kidney Medullary Carcinoma, Malignant Solid Neoplasm, Poorly Differentiated ChordomaStudy StatusOpen
PhaseI/II
Age18 Years and Older until completion of Part ARandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationAtezolizumab and tiragolumab are given intravenously (IV) as infusions
Last Posted Update2024-04-22
ClinicalTrials.gov #NCT05286801
International Sponsor
National Cancer Institute (NCI)
Principal Investigators for Canadian Sites
Patients 18+ years of age until completion of Part A.

CHU Ste Justine - Dr. Monia Marzouki
The Hospital for Sick Children - Dr. Daniel Morgenstern
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
 
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

This is a phase I/II trial that studies how well the treatments tiragolumab and atezolizumab work when given to children with tumours that have either come back (relapsed) or did not respond to therapy (refractory). These tumours must have a certain mutation, meaning the cancer cells are missing important genes called SMARCB1 and SMARCA4. Tiragolumab and atezolizumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Inclusion Criteria
  • Participants must be between 1-18 years old for part A of this study. There is no upper age limit for part B
  • Participants must have one of the following cancers, that has either come back (relapsed) or did not respond to previous treatment (refractory):
    • Renal medullary carcinoma
    • Malignant rhabdoid tumor (extra-CNS)
    • Atypical teratoid rhabdoid tumor (CNS)
    • Poorly differentiated chordoma
    • Epithelioid sarcoma
  • Cancer must have the eligible mutation (SMARCB1 or SMARCA4)
  • Participants must be up and about for at least half their waking hours
  • Participants must meet all bloodwork criteria outlined for this study

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