Immunotherapy with DCVax-L for Brain Cancer

(GBM Trial)

Not currently recruiting at 90 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Northwest Biotherapeutics

Must be taking: Temodar

Disqualifiers: Progressive disease, Biopsy only, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called DCVax-L, a type of immunotherapy, for individuals with glioblastoma (GBM), a form of brain cancer. The goal is to determine if adding DCVax-L to standard treatments—such as surgery, radiation, and Temodar (a chemotherapy drug)—improves outcomes. Two-thirds of participants will receive DCVax-L, while the rest will receive a placebo. Those with newly diagnosed GBM who have undergone surgery and are ready to begin radiation and chemotherapy may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in GBM treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking steroid therapy at least 10 days before a specific procedure called leukapheresis. You must also be willing to avoid other anti-tumor therapies, except for Temodar, while participating in the trial.

Is there any evidence suggesting that DCVax-L is likely to be safe for humans?

Research has shown that DCVax-L, a new treatment being tested for brain cancer, is generally well-tolerated by patients. In studies, some patients lived longer with this treatment. Evidence indicates a 42% reduction in the risk of death for patients treated with DCVax-L compared to those who did not receive it.

The treatment's safety has been tested in a large group of over 300 patients, providing well-documented safety data. While any treatment can have side effects, DCVax-L has shown promising results without major safety concerns in these studies.

These findings suggest that DCVax-L is a relatively safe option for patients considering joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for brain cancer, which often include surgery, radiation, and chemotherapy, DCVax-L offers a novel approach by harnessing the power of the immune system. This treatment is unique because it uses the patient’s own dendritic cells to create a personalized vaccine aimed at targeting and attacking cancer cells. Researchers are excited about DCVax-L because it represents a tailored immunotherapy strategy, potentially leading to more effective and less toxic outcomes compared to traditional therapies. By specifically targeting the tumor cells, DCVax-L could improve survival rates and quality of life for individuals with brain cancer.

What evidence suggests that DCVax-L might be an effective treatment for brain cancer?

Research has shown that DCVax-L, a treatment that aids the immune system in fighting cancer, holds potential for treating glioblastoma, a type of brain cancer. In this trial, some participants will receive DCVax-L, while others will receive a placebo. Studies indicate that patients who received DCVax-L lived longer on average than those who did not. Additionally, the treatment slowed tumor growth. These findings suggest that DCVax-L could complement standard treatments such as surgery, radiation, and Temodar. ^{1 2 3 6 7}

Who Is on the Research Team?

Linda Liau, M.D.

Principal Investigator

University of California, Los Angeles

Marnix L. Bosch, MBA, PhD

Principal Investigator

Northwest Biotherapeutics

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with newly diagnosed, unilateral GBM brain cancer who've had surgery aiming to remove most of the tumor. They should have completed radiation and Temodar chemotherapy, not be on steroids for at least 10 days before leukapheresis, and must avoid other cytotoxic therapies except temozolomide. Participants need proper liver and kidney function, a KPS rating of ≥70, enough tumor material from surgery for vaccine creation, and a life expectancy over 8 weeks.

Inclusion Criteria

I stopped taking steroids at least 10 days before my leukapheresis.

I agree not to receive certain cancer treatments except for temozolomide as per the Stupp Protocol while on DCVax-L.

My initial treatment was surgery to remove as much of the tumor as possible, followed by radiation and Temodar chemotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Resection

Patients undergo surgical resection of the tumor as part of the standard of care

1 week

Standard of Care Treatment

Participants receive radiation and Temodar therapy as part of the standard of care

6 weeks

DCVax-L Treatment

Participants receive a series of injections of DCVax-L to activate and boost the immune response

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Crossover Arm (optional)

Participants have the option to receive DCVax-L upon documented disease progression

What Are the Treatments Tested in This Trial?

Interventions

• DCVax®-L

Trial Overview

The study tests DCVax-L immunotherapy's effectiveness in patients with new GBM after surgical removal of their tumors. Two-thirds will receive DCVax-L plus standard care (radiation & Temodar), while one-third gets a placebo. If the disease worsens, all can get DCVax-L in a crossover arm.

How Is the Trial Designed?

Group I: treatment cohort Active Control 1 Intervention

Group II: Placebo Chohort Placebo Group 1 Intervention

Autologous PBMC

Who Is Running the Clinical Trial?

Northwest Biotherapeutics

Lead Sponsor

Trials

8

Recruited

470+

Published Research Related to This Trial

DCVax-L is a personalized cancer vaccine that uses a patient's own dendritic cells and tumor lysate to stimulate an immune response against glioblastoma multiforme (GBM).

Preliminary results from clinical trials, including ongoing Phase III studies, suggest that DCVax-L may offer a promising treatment option for patients with both newly diagnosed and recurrent GBM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dendritic cell immunotherapy for solid tumors: evaluation of the DCVax® platform in the treatment of glioblastoma multiforme. Hdeib, A., Sloan, AE.[2019]

Dendritic cell (DC) immunotherapy, particularly the DCVax®-L vaccine developed by Northwest Biotherapeutics, shows promise in improving overall survival in patients with glioblastoma multiforme (GBM), based on phase I and II trials.

The side effects associated with DC immunotherapy are generally mild, making it a potentially safe adjunct treatment for patients with newly diagnosed and recurrent GBM, with a phase III trial currently underway.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DCVax®-L--developed by Northwest Biotherapeutics. Polyzoidis, S., Ashkan, K.[2018]

DCVax-Brain, a personalized treatment using dendritic cells to target brain tumors, shows promise in inducing antitumor immunity with low toxicity in patients with glioblastoma multiforme (GBM).

Recent trials indicate that DC vaccine therapy correlates with clinical improvements in GBM patients, although some reports suggest possible selection bias in the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DCVax-Brain and DC vaccines in the treatment of GBM. Wheeler, CJ., Black, KL.[2019]

The DCVax-L trial indicated a potential survival benefit for glioblastoma patients receiving dendritic cell vaccination alongside standard care, showing improved overall survival in both newly diagnosed (19.3 months vs. 16.5 months) and recurrent settings (13.2 months vs. 7.8 months).

However, the trial's design and methodology raised significant concerns, including changes to endpoints and the use of external controls, which may have biased the results and limited the ability to draw reliable conclusions about the efficacy of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous tumor lysate-loaded dendritic cell vaccination in glioblastoma: What happened to the evidence? Olivier, T., Migliorini, D.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10296384/

DCVax-L Vaccination in Patients with Glioblastoma

Active immunotherapy with dendritic cell vaccination in GB has been observed since 1999, demonstrating reduced tumor growth, prolonged survival, ...

2.

abta.org

abta.org/mindmatters/mm-research-update-dcvax-l-phase-3-clinical-trial-data-published/

DCVax-L Phase 3 Clinical Trial Data Published for GBM

Results from a phase 3 trial of DCVax-L, an immunotherapy for glioblastoma patients, were published in the Journal of the American Medical Association (JAMA) ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00045968

Study of a Drug [DCVax®-L] to Treat Newly Diagnosed ...

This Phase III trial is designed to evaluate the impact on survival time, as well as safety, in patients following treatment with DCVax(R)-L, an immunotherapy ...

4.

jamanetwork.com

jamanetwork.com/journals/jamaoncology/fullarticle/2798847

Association of Autologous Tumor Lysate-Loaded Dendritic ...

Meaning In this study, adding DCVax-L to SOC was associated with a clinically meaningful and statistically significant improvement in median OS ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10225952/

DCvax: A promising advancement in oncology for the ...

Based on the findings of the trials evaluating the drug's efficacy, it has the potential to improve the quality of life for patients, especially for the elderly ...

6.

nwbio.com

nwbio.com/nwbio-announces-scientific-publication-interim-survival-data-phase-3-trial-dcvax-l-glioblastoma-brain-cancer/

NW Bio Announces Scientific Publication of Interim ...

Median survival of top 100 patients is 40.5 months, Median survival of all 331 patients is 23.1 months, Longest survivors have exceeded 7 years.

7.

thebraintumourcharity.org

thebraintumourcharity.org/news/research-news/we-respond-to-promising-survival-data-from-phase-iii-trial-of-dcvax-l/

“Promising” survival data from phase III trial of DCVax®-L

The data suggest that adding DCVax-L to existing treatments may offer 2.8 months additional life on average for patients with newly-diagnosed glioblastomas.