Immunotherapy + Radiosurgery for Glioblastoma
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must not be on immunosuppressive medications other than steroids, and certain time intervals from previous treatments are required before starting the trial.
What data supports the effectiveness of this treatment for glioblastoma?
Research shows that combining immunotherapy with stereotactic radiosurgery (SRS) can improve survival in glioblastoma, as seen in studies with mice. The combination of anti-GITR monoclonal antibody and SRS has demonstrated a survival benefit in a glioma model, suggesting potential effectiveness in humans.12345
Is the combination of immunotherapy and radiosurgery generally safe for humans?
Studies suggest that combining immunotherapy with stereotactic radiosurgery (a precise form of radiation therapy) can increase both effectiveness and potential side effects, such as radiation necrosis (tissue damage due to radiation). While these treatments have been tested in various cancers, including gliomas and melanoma, safety data indicates that side effects can occur, and careful monitoring is necessary.26789
How is the treatment of Immunotherapy + Radiosurgery for Glioblastoma different from other treatments?
This treatment combines immunotherapy with stereotactic radiosurgery (SRS), which is a precise form of radiation therapy, to potentially enhance the immune system's ability to fight glioblastoma. The use of anti-GITR and anti-PD-1 antibodies in this combination aims to boost immune response and improve survival, which is a novel approach compared to traditional treatments.2481011
What is the purpose of this trial?
This is a phase II study of the combination of the GITR agonist monoclonal antibody INCAGN01876, the anti-PD1 monoclonal antibody INCMGA00012, and stereotactic radiosurgery (SRS) for recurrent Glioblastoma (GBM). The investigators hypothesize that the proposed regimen will be safe and stimulate a robust anti-tumor immune response and result in improved tumor responses.
Research Team
Stephen Bagley, MD
Principal Investigator
University of Pennsylvania
Eligibility Criteria
Adults over 18 with recurrent glioblastoma who've completed prior treatments, have a life expectancy of more than 3 months, and adequate organ function. They must not be pregnant or breastfeeding and agree to use contraception. Excluded are those with certain brain locations of cancer, previous specific cancer treatments like VEGF inhibitors (unless for radiation necrosis), immunosuppressant use within six months, significant heart disease, other active cancers that could affect the trial's outcomes, or infectious conditions like hepatitis B/C or HIV.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Immunotherapy
Subjects receive a single priming dose of INCMGA00012 and INCAGN01876 prior to stereotactic radiosurgery (SRS) or surgery
Stereotactic Radiosurgery (SRS)
Subjects undergo SRS (8 Gy x 3 fractions) following the priming dose of immunotherapy
Postoperative Immunotherapy
Post-surgery, the immunotherapy combination of INCMGA00012 and INCAGN01876 is resumed and continued until disease progression, unacceptable toxicity, or for 2 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Brain surgery
- INCAGN01876
- INCMGA00012
- Stereotactic Radiosurgery
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Incyte Corporation
Industry Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School