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NCT03451825 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of Avelumab in Pediatric Cancer Participants
A Phase 1 study, sponsored by EMD Serono Research & Development Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT03451825 is a Phase 1 study that was terminated before completion, run by EMD Serono Research & Development Institute. The registered enrollment target is 21 participants.
The verdict
NCT03451825, a Phase 1 study, was terminated before completion, sponsored by EMD Serono Research & Development Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This is a multi-center, open-label, international study to evaluate the dose, safety and tolerability, antitumor activity, pharmacokinetic and pharmacodynamics of avelumab in pediatric subjects 0 to less than 18 years of age with refractory or relapsed malignant solid tumors (including central nervous system tumors) and lymphoma for which no standard therapy is available or for which the subject is not eligible for the existing therapy. The study was planned to be conducted in 2 parts: the dose-finding part (Phase I) and the tumor-specified expansion part (Phase II). However, Phase II was cancelled due to limited clinical benefit of PD-L1 monotherapy in pediatric participants.
Interventions
- DRUG Avelumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-03-07 |
| Est. Completion | 2021-07-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03451825
The ClinicalTrials.gov registry entry for NCT03451825 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Avelumab is the first listed.
NCT03451825 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03451825 about?
NCT03451825 is a clinical study titled "Phase I/II Study of Avelumab in Pediatric Cancer Participants". This is a multi-center, open-label, international study to evaluate the dose, safety and tolerability, antitumor activity, pharmacokinetic and pharmacodynamics of avelumab in pediatric subjects 0 to less than 18 years of age with refractory or relapsed malignant solid tumors (including central nervo...
What is the current status of trial NCT03451825?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2018-03-07. Estimated completion is 2021-07-27.
What interventions are being tested in trial NCT03451825?
The interventions under investigation include: Avelumab (DRUG).
Who is sponsoring clinical trial NCT03451825?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
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