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| Diagnosis | Refractory or relapsed solid tumors, Lymphoma, Non-Hodgkin lymphoma, Other solid tumours | Study Status | Completed |
| Phase | I/II |
| Age | Child, Adult - (up to 18 Years) | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | IV |
| Last Posted Update | 2022-02-23 |
| 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. 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 multi-center, open-label, international study to evaluate the dose, safety and tolerability, antitumor activity, pharmacokinetic and pharmacodynamics of avelumab in pediatric subjects 0 to less than 18 years of age with refractory or relapsed malignant solid tumors (including central nervous system tumors) and lymphoma for which no standard therapy is available or for which the subject is not eligible for the existing therapy.
Inclusion Criteria
- Male or female subjects 0 to less than 18 years of age at the time of first treatment dose with histologically or cytologically confirmed solid malignant tumors (including CNS tumors) or lymphoma for which no standard therapy is available
- Confirmed progression on or refractory to standard therapy or no standard therapy available.
- Availability of archival formalin-fixed, paraffin-embedded block containing tumor tissue, or slides, or a fresh/recent tumor biopsy prior to avelumab treatment for subjects in Phase 2
- Adequate bone marrow, kidney, and liver function
- Other protocol defined inclusion criteria could apply
Exclusion Criteria
- Prior therapy with any antibody or drug targeting T-cell coregulatory proteins
- Concurrent anticancer treatment or immunosuppressive agents
- Prior organ transplantation
- Significant acute or chronic infections
- Other significant diseases or conditions that might impair the subject's tolerance of trial treatment
- Other protocol defined exclusion criteria could apply
