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NCT03006848 · ClinicalTrials.gov registry record · Phase 2
A Phase II Trial of Avelumab in Patients With Recurrent or Progressive Osteosarcoma
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT03006848 is a Phase 2 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 19 participants.
The verdict
NCT03006848, a Phase 2 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study 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.
Interventions
- OTHER Questionnaires
- DRUG Avelumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2017-02-16 |
| Est. Completion | 2020-03-18 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03006848
The ClinicalTrials.gov registry entry for NCT03006848 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Questionnaires is the first listed.
NCT03006848 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03006848 about?
NCT03006848 is a clinical study titled "A Phase II Trial of Avelumab in Patients With Recurrent or Progressive Osteosarcoma". 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 es...
What is the current status of trial NCT03006848?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2017-02-16. Estimated completion is 2020-03-18.
What interventions are being tested in trial NCT03006848?
The interventions under investigation include: Questionnaires (OTHER), Avelumab (DRUG).
Who is sponsoring clinical trial NCT03006848?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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