The goal of this clinical trial is to learn if DOC1021 + pIFN alongside standard of care (SOC) will improve survival in adult patients newly diagnosed with glioblastoma (IDH-wt). It will also evaluate the safety of DOC1021 + pIFN. Researchers will compare DOC1021 dendritic cell immunotherapy regimen added to SOC compared to SOC treatment alone. Participants in the DOC1021 + pIFN + SOC arm will: * Take filgrastim subcutaneously x 5 doses and subsequently undergo a leukapheresis collection * Undergo ultrasound guided perinodal DOC1021 injections every 2 weeks for a total of 3 doses * Receive subcutaneous pIFN injections weekly for a total of 6 doses in parallel with the DOC1021 injections Both arms of the trial will: \- Visit the clinic regularly to assess quality of life, symptoms, medication use, imaging, bloodwork, and to receive SOC treatment with surgery, temozolomide chemotherapy and radiation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Double-loaded dendritic cell vaccine, loaded with tumor lysate and mRNA using proprietary method
SOC brain tumor resection
SOC concomitant temozolomide during radiation and adjuvant temozolomide after radiation
60Gy radiation over 6 weeks in 2Gy fractions
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
ACTIVE_NOT_RECRUITINGCity of Hope
Duarte, California, United States
RECRUITINGHOAG
Newport Beach, California, United States
RECRUITINGUCSF
San Francisco, California, United States
RECRUITINGBaptist MD Anderson Cancer Center
Jacksonville, Florida, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGCooper University Health Care
Camden, New Jersey, United States
RECRUITINGRutgers Cancer Institute
New Brunswick, New Jersey, United States
RECRUITINGAtlantic Health
Summit, New Jersey, United States
RECRUITINGLenox Hill Hospital
New York, New York, United States
RECRUITING...and 8 more locations
Overall survival (time in months from randomization until death for each participant)
Time frame: 5 years
Number of total participants treated with DOC1021 alive at one year post-GBM diagnosis date
One-year survival
Time frame: 1 years
Number of total participants treated with DOC1021 alive two years post-GBM diagnosis date
2-year survival rate
Time frame: 2 years
Number of total participants treated with DOC1021 alive three years post-GBM diagnosis date
3-year survival
Time frame: 3 years
Number of Participants with Adverse Events as Assessed by CTCAE v5.0
Time frame: 3 years
Time in months from initial diagnosis of new diagnosed GBM until declared progression on imaging by RANO 2.0 criteria for all participants
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.