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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 (Merck-Serono Protocol MS100070-0306

Study category: Cancer

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Details
Age

Child to Adult

Phase

I/II - A combination of phases: (1) Research Studies that focus on the safety of a drug. The goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These studies usually involve a small number of participants; and (2) Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Treatment

Location

Childrens Hospital Colorado

Principal Investigator
Margaret Macy,  MD

Margaret Macy, MD

Study ID

Protocol Number: 17-1845

ClinicalTrials.gov: NCT03451825

Categories

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