Dendritic Cell Vaccine + Immunotherapy for Brain Tumor

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Jonsson Comprehensive Cancer Center

Must not be taking: Anti-PD-1, Anti-PD-L1

Disqualifiers: Age, Pregnancy, Autoimmune, Infection, others

Compensation: Varies

Number of Visits: 4

Trial Summary

What is the purpose of this trial?

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.

Research Team

Anthony C. Wang

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

This trial is for people aged 13-60 with a specific brain tumor (Diffuse Hemispheric Glioma, H3 G34-mutant) that's returned or worsened. They must be scheduled for tumor removal surgery and have good organ function. Women of childbearing age need a negative pregnancy test and must use birth control. Participants can't join if they've had certain recent treatments, live vaccines, other cancers within 3 years, severe allergies to the study drugs, active infections or autoimmune diseases.

Inclusion Criteria

The participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial

I have undergone HLA testing.

It has been over 23 days since my last chemotherapy session.

Exclusion Criteria

Has severe hypersensitivity (>= grade 3) to nivolumab or ipilimumab, and/or any of its excipients

I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

I am younger than 13 or older than 60.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgical Treatment

Patients undergo leukapheresis and receive either ppDC, placebo, or nivolumab and ipilimumab prior to surgical resection

10 days

1 visit (in-person)

Post-Surgical Treatment

Patients receive ppDC, placebo, or nivolumab and ipilimumab post-surgical resection, with treatment cycles every 2 weeks for up to 3 cycles

6 weeks

3 visits (in-person)

Long-term Follow-up

Post-treatment, patients may receive nivolumab every 4 weeks for up to 24 months, followed by follow-up visits at 30 days, 6 months, and every 6 months for up to 2 years

Up to 2 years

Regular visits (in-person)

Treatment Details

Interventions

• Dendritic Cell Tumor Peptide Vaccine
• Ipilimumab
• Nivolumab

Trial Overview The trial tests a personalized vaccine made from patients' white blood cells combined with immunotherapy drugs nivolumab and ipilimumab against this aggressive brain tumor. The treatment aims to boost the immune system's response to fight cancer cells more effectively. This approach follows surgical resection of the tumor.

Participant Groups

Group I: Cohort II Arm C (ppDC, nivolumab) Experimental Treatment 3 Interventions

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.

Group II: Cohort II Arm A (ppDC, placebo) Experimental Treatment 3 Interventions

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.

Group III: Cohort I Arm C (ppDC, nivolumab, ipilimumab) Experimental Treatment 6 Interventions

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.

Group IV: Cohort I Arm B (placebo, nivolumab, ipilimumab) Placebo Group 6 Interventions

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.

Group V: Cohort I Arm A (ppDC, placebo) Placebo Group 5 Interventions

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.

Group VI: Cohort II Arm B (placebo, nivolumab) Placebo Group 3 Interventions

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.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+