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NCT03018288 · ClinicalTrials.gov registry record · Phase 2
Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
NCT03018288: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT03018288 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 90 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03018288, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Pembrolizumab
- OTHER Placebo
- DRUG Temozolomide
- PROCEDURE Surgery
- BIOLOGICAL HSPPC-96
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2017-09-21 |
| Est. Completion | 2022-12-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03018288
The ClinicalTrials.gov registry entry for NCT03018288 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03018288 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03018288 about?
NCT03018288 is a clinical study titled "Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)". 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 st...
What is the current status of trial NCT03018288?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2017-09-21. Estimated completion is 2022-12-20.
What interventions are being tested in trial NCT03018288?
The interventions under investigation include: Pembrolizumab (DRUG), Placebo (OTHER), Temozolomide (DRUG), Surgery (PROCEDURE), HSPPC-96 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03018288?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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