Combination Therapy + Radiation for Glioblastoma
Trial Summary
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but certain drugs are prohibited, especially if you are in regimen B. These include MAOIs, UGT1A9 inhibitors, probiotics, and warfarin. If you are on these, you may need to stop them before joining the trial.
What data supports the effectiveness of the drug combination therapy including Bevacizumab for treating glioblastoma?
Is the combination of Bevacizumab and radiation therapy safe for treating glioblastoma?
Bevacizumab, when combined with radiation therapy, has been linked to safety concerns such as stroke, bleeding, and wound-healing issues, especially in glioblastoma patients. However, studies have shown that while these side effects are known, the combination is generally considered feasible and provides additional safety data for treating high-grade gliomas.24567
What makes this treatment for glioblastoma unique?
This treatment combines bevacizumab, which targets blood vessel growth in tumors, with epacadostat and retifanlimab, which are immune-modulating drugs, alongside radiation therapy. This combination aims to enhance the effectiveness of radiation by inhibiting tumor blood supply and boosting the immune response, offering a novel approach compared to standard treatments.12689
What is the purpose of this trial?
This trial is testing a combination of treatments including a new drug, radiation therapy, and other medications for patients with aggressive brain cancer that has returned. The goal is to boost the body's immune system to better fight the cancer, shrink tumors, and help patients live longer.
Research Team
Milan Chheda, M.D.
Principal Investigator
Washington University School of Medicine
Eligibility Criteria
This trial is for adults with recurrent grade 4 glioblastoma or gliosarcoma who have measurable disease, normal organ and bone marrow function, and a Karnofsky performance status ≥ 60%. Patients must not be on high doses of steroids or have active infections, uncontrolled HIV/hepatitis B/C, certain heart conditions, autoimmune diseases requiring systemic treatment in the past 2 years (except under specific conditions), or a history of allergic reactions to similar drugs.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive retifanlimab, radiation therapy, and bevacizumab with or without epacadostat for recurrent glioblastoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for progression-free survival and overall survival
Treatment Details
Interventions
- Bevacizumab
- Epacadostat
- Radiation therapy
- Retifanlimab
Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:
- Colorectal cancer
- Breast cancer
- Non-small cell lung cancer
- Renal cell carcinoma
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Glioblastoma
- Renal cell carcinoma
- Cervical cancer
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
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