Immunotherapy with DCVax-L for Brain Cancer

(GBM Trial)

Recruiting at 86 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Northwest Biotherapeutics

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

348 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests DCVax-L, a treatment using a patient's own immune cells, in patients with newly diagnosed GBM undergoing surgery. It aims to train their immune system to better attack brain cancer cells. This treatment is being tested in several clinical trials, with safety and feasibility proven and promising clinical results reported.

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.

What data supports the effectiveness of the treatment DCVax-L for brain cancer?

Research shows that DCVax-L, a personalized treatment using a patient's own cells, has improved survival rates for people with glioblastoma, a type of brain cancer. In a trial, patients receiving DCVax-L lived longer than those who did not, with newly diagnosed patients living a median of 19.3 months compared to 16.5 months for those not receiving the treatment. ^{1 2 3 4 5}

Is DCVax-L safe for humans?

DCVax-L has been tested in clinical trials for brain cancer, and the side effects reported are generally mild. ^{1 2 4 5 6}

How is the treatment DCVax-L different from other treatments for brain cancer?

DCVax-L is unique because it uses a personalized approach by employing the patient's own immune cells (dendritic cells) combined with their tumor material to create a vaccine that helps the immune system target and fight the brain cancer. This method aims to improve survival rates with fewer side effects compared to traditional treatments. ^{1 2 3 5 6}

Research Team

Linda Liau, M.D.

Principal Investigator

University of California, Los Angeles

Marnix L. Bosch, MBA, PhD

Principal Investigator

Northwest Biotherapeutics

Eligibility Criteria

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.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

DCVax-Brain and DC vaccines in the treatment of GBM. [2019]

3. France pubmed.ncbi.nlm.nih.gov

Autologous tumor lysate-loaded dendritic cell vaccination in glioblastoma: What happened to the evidence? [2023]

4. England pubmed.ncbi.nlm.nih.gov

Technology evaluation: DCVax, Northwest Biotherapeutics. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

DCVax®-L--developed by Northwest Biotherapeutics. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Assessment of treatment response to dendritic cell vaccine in patients with glioblastoma using a multiparametric MRI-based prediction model. [2023]