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

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a Phase 2 study using a traditional Simon two-stage design. Patients 12 years or greater with recurrent/refractory osteosarcoma will be administered avelumab at a dose of 10 mg/kg intravenously (IV) over 60 minutes on days 1 and 15 of each cycle, with a cycle lasting 28 days. Patients will receive avelumab every 2 weeks in cycles of 28 days for up to 24 months, or 26 cycles. Progression free survival and response to therapy after 4 cycles of treatment will be assessed. In addition, the toxicity profile of avelumab in this population will be closely monitored. ;

Study Design

Related Conditions & MeSH terms

Osteosarcoma

Clinical Trial Details

NCT number	NCT03006848
Study type	Interventional
Source	St. Jude Children's Research Hospital
Contact
Status	Completed
Phase	Phase 2
Start date	February 16, 2017
Completion date	March 18, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms