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Title
Status

 

CA209-744 - Risk-based, Response-adapted, Phase II Open-label Trial of Nivolumab + Brentuximab Vedotin (N + Bv) for Children, Adolescents, and Young Adults With Relapsed/Refractory (R/R) CD30 + Classic Hodgkin Lymphoma (cHL) After Failure of First-line Therapy, Followed by Brentuximab + Bendamustine (Bv + B) for Participants With a Suboptimal Response (CheckMate 744: CHECKpoint Pathway and Nivolumab Clinical)

Closed to enrollment

CA209-744 - Risk-based, Response-adapted, Phase II Open-label Trial of Nivolumab + Brentuximab Vedotin (N + Bv) for Children, Adolescents, and Young Adults With Relapsed/Refractory (R/R) CD30 + Classic Hodgkin Lymphoma (cHL) After Failure of First-line Therapy, Followed by Brentuximab + Bendamustine (Bv + B) for Participants With a Suboptimal Response (CheckMate 744: CHECKpoint Pathway and Nivolumab Clinical)

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DiagnosisHodgkin Disease, Hodgkin lymphoma, relapsed, refractoryStudy StatusClosed to enrollment
PhaseII
AgeChild, Adult - (5 Years to 30 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationIV
Last Posted Update2023-01-05
ClinicalTrials.gov #NCT02927769
International Sponsor
Bristol-Myers Squibb
Principal Investigators for Canadian Sites
Montreal Children's Hospital – Dr. Sharon Abish
Alberta Children's Hospital – Dr. Victor Lewis
The Hospital for Sick Children - Dr. Ute Bartels
Centres
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

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

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.