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Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)
Study Purpose
Background: Glioblastoma (GBM) refers to a specific kind of brain cancer called glioblastoma. The standard treatment for GBM is radiation plus temozolomide, an oral chemotherapy drug. Pembrolizumab is an immune therapy that is now used to treat other cancers. The addition of pembrolizumab to the standard treatment of radiation and temozolomide has been shown to be well tolerated. Researchers want to see if adding a vaccine made from the person's own tumor will improve the effect of the pembrolizumab. The vaccine which is developed from fresh tumor taken at the time of surgery is called heat shock protein peptide complex-96 (HSPPC-96). Objectives: To see if the adding of pembrolizumab and HSPPC-96 improves the standard treatment for glioblastoma. Eligibility: Adults at least 18 years old with glioblastoma. Design: Participants will be screened with typical cancer tests: Brain scan. Medical history. Blood and urine tests. Questions about quality of life and symptoms. These tests will be repeated throughout the study. Participants will have surgery to remove their tumor. A tissue sample from the tumor will be sent to a lab. A vaccine will be made from it. Some participants will get pembrolizumab and vaccine. Some will get pembrolizumab and placebo. Participants will not know which they get. Participants will get radiation for 6 weeks. Participants will take temozolomide by mouth before each treatment. Participants will get pembrolizumab by intravenous (IV) for 30 minutes 3 times over the radiation cycle. Participants will keep taking the 2 drugs every few weeks for about a year. Some may take pembrolizumab for an additional year. Most participants will get the vaccine or placebo after radiation. They will get it 5 times over 6 weeks. Some participants will continue to get the vaccine every few weeks for 1 or 2 years. Participants will repeat the screening tests when they stop study treatment. They will also have follow-up phone calls.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03018288 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
National Cancer Institute (NCI) |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Mark R Gilbert, M.D. |
Principal Investigator Affiliation | National Cancer Institute (NCI) |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
NIH |
Overall Status | Completed |
Countries | United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Glioblastoma |
Study Website: | View Trial Website |
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