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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: Clinical Trial Phase 1 study, sponsored by Nicholas Butowski.

NCT02924038 is a Phase 1 study that was terminated before completion, run by Nicholas Butowski. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The proportion of participants experiencing and RLT defined as an adverse event judged to be possibly, probably or definitely associated with treatment that requires participants to be taken off study and no further injections will be given will be reported.

Interventions

  • BIOLOGICAL Varlilumab
  • BIOLOGICAL poly-ICLC
  • BIOLOGICAL IMA950

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2017-04-03
Est. Completion 2022-12-31
Phase Phase 1
Nicholas Butowski

2 total trials

Why NCT02924038 stopped before completion

NCT02924038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 3 interventions - of which Varlilumab is the first listed.

NCT02924038 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02924038's enrollment target sits among peer trials

14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT02924038, the US trial registry maintained by the National Library of Medicine. NCT02924038 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.