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A Study of Varlilumab and IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade Glioma (LGG)

NCT02924038 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-06-14

Study results available
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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.

Conditions

  • Glioma
  • Malignant Glioma
  • Astrocytoma, Grade II
  • Oligodendroglioma
  • Glioma, Astrocytic
  • Oligoastrocytoma, Mixed

Interventions

BIOLOGICAL

IMA950

IMA950 vaccine

BIOLOGICAL

poly-ICLC

poly-ICLC vaccine

BIOLOGICAL

Varlilumab

Intravenous solution

Sponsors & Collaborators

  • Celldex Therapeutics

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • Nicholas Butowski

    lead OTHER

Principal Investigators

  • Hideho Okada, MD, PhD · University of California, San Francisco

  • Nicholas Butowski, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-03
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02924038 on ClinicalTrials.gov