A Phase II Trial of Avelumab in Patients With Recurrent or Progressive Osteosarcoma

Phase 2 Completed NCT03006848

Summary

This clinical trial seeks to determine if avelumab will be effective in facilitating removal of all gross tumor in the event of a relapse of osteosarcoma in pediatric patients. Avelumab will be evaluated using dosing that has previously been determined in adult studies. Primary Objectives: * To estimate the response rate to 4 cycles of avelumab in patients with recurrent or progressive osteosarcoma. * To estimate the 16-week progression free survival of patients with recurrent or progressive osteosarcoma after treatment with avelumab. Secondary Objective: * To describe the toxicities associated with the administration of avelumab in patients with recurrent or progressive osteosarcoma. * To assess the quality of life of patients with recurrent or progressive osteosarcoma undergoing treatment with avelumab, and to explore relationships between clinical factors and patient-reported health-related quality of life (HRQOL) outcomes. Exploratory Objectives: * To explore factors associated with response in patients treated with avelumab after recurrent or progressive osteosarcoma (e.g. tumor PD-L1 expression). * To measure parameters of immune activation including subsets of peripheral blo

Response Rate

At the end of 4 cycles of avelumab (approximately 4 months) · percentage of participants

Progression-free Survival

At the end of 4 cycles of avelumab (approximately 4 months) · percentage of weeks

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