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Peptide-Pulsed Dendritic Cell Vaccination in Combination With Nivolumab and Ipilimumab for the Treatment of Recurrent and/or Progressive Diffuse Hemispheric Glioma, H3 G34-mutant

NCT05457959 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-02-24

No results posted yet for this study

Summary

This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer.

Conditions

  • Diffuse Hemispheric Glioma, H3 G34-Mutant

Interventions

BIOLOGICAL

Dendritic Cell Tumor Peptide Vaccine

Given ID

BIOLOGICAL

Ipilimumab

Given IV

PROCEDURE

Leukapheresis

Undergo leukapheresis

BIOLOGICAL

Nivolumab

Given IV

DRUG

Placebo Administration

Given ID

DRUG

Placebo Administration

Given IV

DRUG

Poly ICLC

Given IM

PROCEDURE

Resection

Undergo standard of care surgical resection

Sponsors & Collaborators

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Anthony C Wang · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
13 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2029-12-01
Completion
2030-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT05457959 on ClinicalTrials.gov