Phase I/II Study of Avelumab in Pediatric Cancer Participants

Stopped early · Phase 1

Conditions studied: Refractory or Relapsed Solid Tumors, Lymphoma

In brief

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. The study was planned to be conducted in 2 parts: the dose-finding part (Phase I) and the tumor-specified expansion part (Phase II). However, Phase II was cancelled due to limited clinical benefit of PD-L1 monotherapy in pediatric participants.

Key facts

Study ID

NCT03451825

Run by

EMD Serono Research & Development Institute, Inc.

People needed

21

Starts

2018-03-07

Expected to finish

2021-07-27

Last updated by the study team

2024-06-24

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States
• The Children's Hospital at Montefiore (CHAM) — The Bronx, New York, United States
• Cliniques Universitaires Saint-Luc — Brussels, Belgium
• UZ Leuven — Leuven, Belgium
• Children's Hospital - London Health Sciences Centre — London, Canada
• CHU Sainte-Justine — Montreal, Canada
• The Hospital for Sick Children — Toronto, Canada
• Rigshospitalet — Copenhagen, Denmark
• Samsung Medical Center — Seoul, South Korea
• Seoul National University Hospital — Seoul, South Korea
• Severance Hospital, Yonsei University — Seoul, South Korea

Full record on ClinicalTrials.gov

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