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NCT02924038 · ClinicalTrials.gov registry record · Phase 1
A Study of Varlilumab and IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade Glioma (LGG)
A Phase 1 study, sponsored by Nicholas Butowski.
- Terminated
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT02924038 is a Phase 1 study that was terminated before completion, run by Nicholas Butowski. The registered enrollment target is 14 participants.
The verdict
NCT02924038, a Phase 1 study, was terminated before completion, sponsored by Nicholas Butowski.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This is a pilot, randomized, two arm neoadjuvant vaccine study in human leukocyte antigen-A2 positive (HLA-A2+) adults with World Health Organization (WHO) grade II glioma, for which surgical resection of the tumor is clinically indicated. Co-primary objectives are to determine: 1) the safety of the novel combination of subcutaneously administered IMA950 peptides and poly-ICLC (Hiltonol) and i.v. administered CDX-1127 (Varlilumab) in the neoadjuvant approach; and 2) whether addition of i.v. CDX-1127 (Varlilumab) increases the response rate and magnitude of CD4+ and CD8+ T-cell responses against the IMA950 peptides in post-vaccine peripheral blood mononuclear cell (PBMC) samples obtained from participating patients.
Interventions
- BIOLOGICAL Varlilumab
- BIOLOGICAL poly-ICLC
- BIOLOGICAL IMA950
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2017-04-03 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02924038
The ClinicalTrials.gov registry entry for NCT02924038 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nicholas Butowski, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Varlilumab is the first listed.
NCT02924038 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02924038 about?
NCT02924038 is a clinical study titled "A Study of Varlilumab and IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade Glioma (LGG)". This is a pilot, randomized, two arm neoadjuvant vaccine study in human leukocyte antigen-A2 positive (HLA-A2+) adults with World Health Organization (WHO) grade II glioma, for which surgical resection of the tumor is clinically indicated. Co-primary objectives are to determine: 1) the safety of the...
What is the current status of trial NCT02924038?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2017-04-03. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT02924038?
The interventions under investigation include: Varlilumab (BIOLOGICAL), poly-ICLC (BIOLOGICAL), IMA950 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02924038?
This trial is sponsored by Nicholas Butowski, which has 2 total clinical trials registered on ClinicalTrials.gov.
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