Spots Global Cancer Trial Database for Phase I/II Study of Avelumab in Pediatric Cancer Subjects
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Trial Identification
Brief Title: Phase I/II Study of Avelumab in Pediatric Cancer Subjects
Official Title: 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
Study ID: NCT03451825
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 0 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Colorado, Aurora, Colorado, United States
The Children's Hospital at Montefiore (CHAM), Bronx, New York, United States
Cliniques Universitaires Saint-Luc, Bruxelles, , Belgium
UZ Leuven, Leuven, , Belgium
Children's Hospital - London Health Sciences Centre, London, , Canada
CHU Sainte-Justine, Montréal, , Canada
The Hospital for Sick Children, Toronto, , Canada
Rigshospitalet, Copenhagen, , Denmark
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University, Seoul, , Korea, Republic of
Contact Details
Name: Medical Responsible
Affiliation: Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR
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