A Phase II Trial of Avelumab in Patients With Recurrent or Progressive Osteosarcoma
Status:
Active, not recruiting
Trial end date:
2023-01-31
Target enrollment:
Participant gender:
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 blood
mononuclear cells (PBMCs) and serum markers of immune activation.
- To evaluate the role of T-cells in immune checkpoint blockade via measures of cell
proliferation, co-inhibitory receptor expression on CD8 T cells, T cell repertoire, and
epigenetic programming.
Phase:
Phase 2
Details
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborators:
Gateway for Cancer Research National Cancer Institute (NCI) Pfizer