Dendritic Cell Vaccine + Standard Therapy for Glioblastoma
(DERIVe 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.12345Why 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.14567Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation and Concurrent Chemotherapy
Participants receive standard of care radiation therapy and concurrent temozolomide for 6 weeks
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Human CMV pp65-LAMP mRNA-pulsed autologous DCs
- Td
- Temozolomide
- Unpulsed DCs
- Varlilumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Annick Desjardins, MD
Lead Sponsor
Gary Archer Ph.D.
Lead Sponsor
Celldex Therapeutics
Industry Sponsor
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