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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: Completed Phase 2 study, sponsored by St. Jude Children's Research Hospital.
NCT03006848 is a Phase 2 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The study is designed by treating RECIST response \[complete response + partial response (CR+PR)\] after 4-cycle treatment of avelumab and the 16-week progression-free survival (PFS) as dual binary endpoints. Patients who fail to be evaluated at the end of the 4-cycle will be counted as failure.
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 |
What the finished NCT03006848 record still lists
NCT03006848 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Questionnaires is the first listed.
NCT03006848 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03006848's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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