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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT05457959
Phase
PHASE1
Status
Withdrawn

Conditions

  • Diffuse Hemispheric Glioma, H3 G34-Mutant

Eligibility Criteria

Sex
ALL
Age
13 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Dendritic Cell Tumor Peptide Vaccine — BIOLOGICAL
    Given ID
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Leukapheresis — PROCEDURE
    Undergo leukapheresis
  • Nivolumab — BIOLOGICAL
    Given IV
  • Placebo Administration — DRUG
    Given ID
  • Placebo Administration — DRUG
    Given IV
  • Poly ICLC — DRUG
    Given IM
  • Resection — PROCEDURE
    Undergo standard of care surgical resection

Study Details

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.

Key Dates

Start date
Dec 1, 2024
Status verified
Mar 2024
Primary completion
Dec 1, 2029
Completion
Dec 1, 2030

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Cohort I Arm A (ppDC, placebo)
    Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID in both arms with poly ICLC IM on day -10 and placebo IV on day -9 prior to standard of care surgical resection.
  • Placebo Comparator: Cohort I Arm B (placebo, nivolumab, ipilimumab)
    Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.
  • Experimental: Cohort I Arm C (ppDC, nivolumab, ipilimumab)
    Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.
  • Experimental: Cohort II Arm A (ppDC, placebo)
    Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.
  • Placebo Comparator: Cohort II Arm B (placebo, nivolumab)
    Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.
  • Experimental: Cohort II Arm C (ppDC, nivolumab)
    Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Start of treatment up to 100 days post-treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095-

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By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CA

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