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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.

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Title
Status

 

MS100070-0306 - Open-label, Phase I/II Study to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Anticancer Activity of Avelumab in Pediatric Subjects From Birth to Less Than 18 Years of Age With Refractory or Relapsed Solid Tumors and Lymphoma

Completed

More information

MS100070-0306 - Open-label, Phase I/II Study to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Anticancer Activity of Avelumab in Pediatric Subjects From Birth to Less Than 18 Years of Age With Refractory or Relapsed Solid Tumors and Lymphoma

Go to Health Care Provider version

DiagnosisRefractory or relapsed solid tumors, Lymphoma, Non-Hodgkin lymphoma, Other solid tumoursStudy StatusCompleted
PhaseI/II
AgeChild, Adult - (up to 18 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationIV
Last Posted Update2022-02-23
ClinicalTrials.gov #NCT03451825
International Sponsor
EMD Serono Research & Development Institute, Inc.
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
CHU Ste Justine - Dr. Yvan Samson
Children's Hospital of Western Ontario - Dr. Alexandra Zorzi
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
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. 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 is a study to evaluate the dose, safety, tolerability, antitumor activity and other pharmacologic characteristics of avelumab (an antibody that binds and blocks PDL-1 on tumour cells).

This study has two parts. Part 1 will find the recommended dose for avelumab therapy and evaluate its safety. Part 2 will further evaluate the efficacy of avelumab therapy.

Inclusion Criteria
  • Age between 0 and 18
  • Solid malignant tumors (including brain tumors) or lymphoma for which no standard therapy is available, or with confirmed progression, or refractory to standard therapy
  • Availability of tumor sample collected prior to avelumab treatment for subjects in Phase 2
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.