Pembrolizumab + Standard Therapy for Glioblastoma
Trial Summary
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Pembrolizumab + Standard Therapy for Glioblastoma?
Research shows that combining temozolomide (a chemotherapy drug) with radiotherapy can help control glioblastoma, a type of brain cancer. Additionally, immune checkpoint inhibitors like nivolumab, which are similar to pembrolizumab, have been studied for their potential to enhance the effects of standard treatments in glioblastoma.12345
Is the combination of Pembrolizumab and standard therapy for glioblastoma safe for humans?
Pembrolizumab (KEYTRUDA) has been approved for use in other conditions like metastatic melanoma, with common side effects including fatigue, cough, nausea, and rash. Temozolomide, used in brain tumors, has a good safety profile and is generally well tolerated. Combining these with radiation therapy has shown to be safe in various studies, although specific safety data for glioblastoma is limited.13678
What makes the treatment with pembrolizumab, radiation, and temozolomide unique for glioblastoma?
This treatment combines pembrolizumab, an immunotherapy drug that helps the immune system attack cancer cells, with radiation and temozolomide, a chemotherapy drug that makes cancer cells more sensitive to radiation. This combination aims to enhance the overall effectiveness against glioblastoma, which is typically resistant to standard treatments.123910
What is the purpose of this trial?
This phase II trial studies the side effects and how well pembrolizumab works in combination with standard therapy in treating patients with glioblastoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in the chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving pembrolizumab and standard therapy comprising of temozolomide and radiation therapy may kill tumor cells.
Research Team
Ian F. Parney, MD, PhD
Principal Investigator
Mayo Clinic in Rochester
Eligibility Criteria
Adults with confirmed glioblastoma or astrocytoma grade IV, who can provide consent and samples for research. They must have adequate organ function, no severe diseases that could interfere with the trial, not be pregnant or nursing, agree to use contraception if of childbearing potential, and be willing to return for follow-up. Excluded are those with recent heart issues, active autoimmune disease requiring treatment in the past 2 years (except certain conditions), current pneumonitis or infections, HIV on antiretroviral therapy, other cancers being treated within 5 years.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant
Patients receive pembrolizumab intravenously over 30 minutes on day 1
Surgery
Patients undergo standard of care surgery within days 4-7
Concurrent
Patients receive pembrolizumab and temozolomide, and undergo external beam radiation therapy
Adjuvant
Patients receive pembrolizumab and temozolomide in cycles, repeating every 63 days for up to 5 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- External Beam Radiation Therapy
- Laboratory Biomarker Analysis
- Pembrolizumab
- Radiation Therapy
- Temozolomide
- Therapeutic Conventional Surgery
External Beam Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Cancer Institute (NCI)
Collaborator