Dendritic Cell Vaccine + Standard Therapy for Glioblastoma

(DERIVe Trial)

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Overseen ByStevie Threatt, RN, BSN
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Annick Desjardins, MD
Must be taking: Corticosteroids
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new dendritic cell vaccine combined with standard treatments for glioblastoma, a type of brain cancer. Researchers aim to determine if the vaccine can enhance the body's immune response to combat the cancer more effectively than standard treatments alone. Participants will be divided into three groups, each receiving different pre-conditioning before the vaccine. One group will also receive a drug called varlilumab to potentially enhance the vaccine's effects. The trial seeks individuals newly diagnosed with glioblastoma who have already undergone surgery to remove the tumor. Candidates should also be eligible to receive radiation and a chemotherapy drug called temozolomide. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that co-medication that may interfere with study results, such as immuno-suppressive agents other than corticosteroids, is not allowed. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dendritic cell vaccines have been safe and effective in various applications. For instance, studies on vaccines using CMV RNA-pulsed dendritic cells have demonstrated safety and general tolerability. This suggests potential safety for treating glioblastoma as well.

Regarding varlilumab, research indicates it is well-tolerated, with no major side effects beyond those typical for similar treatments. This suggests varlilumab is likely safe for participants in this study.

Overall, while these treatments have been well-tolerated in past research, individual responses can vary. Participants should monitor their health and discuss any concerns with their healthcare team.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for glioblastoma because they introduce a novel approach using dendritic cell (DC) vaccines, which are designed to train the immune system to target cancer cells. Unlike standard treatments like surgery, radiation, and chemotherapy, these vaccines use human CMV pp65-LAMP mRNA to pulse autologous DCs, potentially enhancing the body's immune response against the tumor. Additionally, the inclusion of varlilumab and Td toxoid as pre-conditioning agents is a unique feature that might boost the effectiveness of the vaccines. This innovative method offers hope for a more targeted and potentially more effective treatment for this aggressive form of brain cancer.

What evidence suggests that this trial's treatments could be effective for glioblastoma?

Research has shown that dendritic cell (DC) vaccines, one of the treatments in this trial, can improve outcomes for glioblastoma patients when used alongside standard treatments. These vaccines have been linked to better overall survival and longer periods without disease progression, indicating they help the immune system fight the tumor more effectively. Studies have found that patients receiving these vaccines lived longer compared to those who did not.

In this trial, some participants will receive Varlilumab, an antibody that boosts the immune system, in combination with the DC vaccine. Varlilumab has been shown to be safe and effective when combined with other treatments for recurring glioblastoma and has shown promise when used with vaccines, potentially strengthening the immune response against tumors. These findings provide hope that the combined treatment approach in this trial could be effective against glioblastoma.14567

Who Is on the Research Team?

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Annick Desjardins, MD, FRCPC

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

Adults with glioblastoma who've had a tumor resection, meet certain health criteria (like KPS ≥ 70%, specific blood cell counts), are not pregnant or breastfeeding, agree to use effective contraception, and can undergo standard radiation/chemotherapy. Excluded are those with severe allergies, metal implants preventing MRI, other cancers needing active treatment, certain infections or heart conditions.

Inclusion Criteria

I had surgery for glioblastoma and my latest scans show a small remaining area of less than 1 cm.
My MRI after radiation shows no cancer spread outside the treated area.
My kidney and liver tests are within acceptable limits for my age.
See 8 more

Exclusion Criteria

I am not using birth control and can become pregnant or cause pregnancy.
I cannot have an MRI due to my weight or because I have certain metal implants.
My cancer has spread to my brain.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation and Concurrent Chemotherapy

Participants receive standard of care radiation therapy and concurrent temozolomide for 6 weeks

6 weeks
Weekly visits for radiation therapy

Adjuvant Chemotherapy and DC Vaccination

Participants receive temozolomide cycles and dendritic cell vaccines. DC vaccines #1-3 are given every 2 weeks, delaying TMZ cycle 2. Remaining cycles are 4 weeks long.

Up to 48 weeks
Bi-weekly visits initially, then monthly

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Human CMV pp65-LAMP mRNA-pulsed autologous DCs
  • Td
  • Temozolomide
  • Unpulsed DCs
  • Varlilumab
Trial Overview The trial tests dendritic cell vaccines in glioblastoma patients post-surgery. Patients receive standard radiation and temozolomide chemotherapy plus up to 10 DC vaccines. They're randomized into groups receiving different pre-conditioning before the fourth vaccine; one group also gets varlilumab infusions.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Gr3:DC Vaccine+varlilumab(Td pre-conditioning)Experimental Treatment4 Interventions
Group II: Gr2: DC Vaccine (Td pre-conditioning)Experimental Treatment3 Interventions
Group III: Gr1: DC vaccine (DC pre-conditioning)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Annick Desjardins, MD

Lead Sponsor

Trials
3
Recruited
150+

Gary Archer Ph.D.

Lead Sponsor

Trials
12
Recruited
290+

Celldex Therapeutics

Industry Sponsor

Trials
66
Recruited
5,900+

Anthony S. Marucci

Celldex Therapeutics

Chief Executive Officer since 2008

MBA from Columbia University, MHL from Brown University

Diane C. Young

Celldex Therapeutics

Chief Medical Officer since 2019

MD from Harvard Medical School, AB in Biochemical Sciences from Harvard University

Citations

Long-term Survival in Glioblastoma with Cytomegalovirus ...Patients with glioblastoma (GBM) have a <15 month median survival despite surgical resection, high-dose radiation and chemotherapy with temozolomide (TMZ).
Study Details | NCT03927222 | Immunotherapy Targeted ...2x10^7 human CMV pp65-LAMP mRNA-pulsed autologous DCs are given intradermally and bilaterally at the groin site (divided equally to both inguinal regions).
Development and Characterization of an HCMV Multi ...Glioblastoma (GBM) is an aggressive form of brain cancer with a median survival of 15 months which has remained unchanged despite advances ...
Human CMV pp65-LAMP mRNA-pulsed autologous DCs ...Clinical Trials associated with Human CMV pp65-LAMP mRNA-pulsed autologous DCs(Celldex Therapeutics). NCT03688178. / Active, not recruitingPhase 2IIT.
Promising Cancer Vaccine for Glioblastoma Therapy: A ...To review current vaccine strategies for GBM, including peptide, virotherapy, cell-based, and genetic vaccines, with a focus on mRNA vaccines.
Personalized mRNA vaccines in glioblastoma therapyThis review focuses on the emerging use of mRNA vaccines for GBM treatment. We summarize recent advancements, evaluate current obstacles, and discuss notable ...
ATTAC-P: A Phase 1 Trial of CMV RNA-Pulsed Dendritic ...Vaccination and adoptive T cell strategies targeting cytomegalovirus (CMV) in humans in other contexts have been found to be safe and effective.
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