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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

 

ADVL1412 - A Phase 1/2 Study of Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Solid Tumors as a Single Agent and in Combination With Ipilimumab

Completed

More information

ADVL1412 - A Phase 1/2 Study of Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Solid Tumors as a Single Agent and in Combination With Ipilimumab

Go to Health Care Provider version

Diagnosissolid tumors, Ewing Sarcoma, osteosarcoma, neuroblastoma, PNET, rhabdomyosarcoma, Hodgkin lymphoma, non-Hodgkin lymphoma, melanomaStudy StatusCompleted
PhaseI/II
AgeChild, Adult - (12 Months to 30 Years )RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationNivolumab - IV
Last Posted Update2021-09-03
ClinicalTrials.gov #NCT02304458
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

Nivolumab is a type of therapy called immunotherapy that works by attempting to help the body's immune system attack the cancer. This study is to assess the effectiveness of  nivolumab on relapsed or refractory solid tumors in children. The maximum tolerated dose and recommended dose for children will be explored. The study also looks at the side effects associated with this medication. Based on the tumor type, patients are categorized into Parts A through E and receIve nivolumab in recurring cycles. 

 

Inclusion Criteria
  • There are multiple parts to this study. Some parts include children between 1 and 18 years old, while others include patients between 1 and 30 years old
  • Different types of recurrent or refractory solid tumors are included in this study including neuroblastoma, osteosarcoma, rhabdomyosarcoma, Ewing sarcoma, peripheral primitive neuroectodermal tumor (PNET), Hodgkin lymphoma, non-Hodgkin lymphoma and melanoma 
  • Patients with brain tumors or brain metastases from their cancer are not included in this study 
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team
Publications

Davis KL, Fox E, Merchant MS, Reid JM, Kudgus RA, Liu X, Minard CG, Voss S, Berg SL, Weigel BJ, Mackall CL. Nivolumab in children and young adults with relapsed or refractory solid tumours or lymphoma (ADVL1412): a multicentre, open-label, single-arm, phase 1-2 trial. Lancet Oncol. 2020 Apr;21(4):541-550. doi: 10.1016/S1470-2045(20)30023-1. Epub 2020 Mar 17.

Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Review.