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NCT03197506 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab and Standard Therapy in Treating Patients With Glioblastoma
A Phase 2 study of Glioblastoma and Gliosarcoma, sponsored by Mayo Clinic.
- Active
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
- 3
- Study locations
NCT03197506: Active Phase 2 study of Glioblastoma and Gliosarcoma, sponsored by Mayo Clinic.
NCT03197506 is a Phase 2 study of Glioblastoma and Gliosarcoma that is active but no longer recruiting, run by Mayo Clinic. The registered enrollment target is 52 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (52% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03197506, a Phase 2 study of Glioblastoma and Gliosarcoma, is active but no longer recruiting, sponsored by Mayo Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Primary Outcome
A dose limiting toxicity DLT will be defined as an adverse event attributed (definitely, probably, or possibly) to pembrolizumab per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Criteria: Grade 4 or higher neutropenia last at least 7 days. Grade 3 electrolyte alteration, nausea, vomiting, or diarrhea lasting at least 3 days. Grade 3 or higher neurologic toxicity. Toxicities leading to delayed treatment of at least 14 days. Inability to proce
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- RADIATION External Beam Radiation Therapy
- OTHER Laboratory Biomarker Analysis
- RADIATION Radiation Therapy
- DRUG Temozolomide
Study Locations (3)
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2018-01-15 |
| Est. Completion | 2028-06-06 |
| Phase | Phase 2 |
What the registry record for NCT03197506 still lists
NCT03197506 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (52% lower).
The record links to 3 conditions, with Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03197506 reports a single indexed study location in Arizona, Minnesota.
Frequently Asked Questions
What is clinical trial NCT03197506 about?
NCT03197506 is a clinical study titled "Pembrolizumab and Standard Therapy in Treating Patients With Glioblastoma". 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 ...
What is the current status of trial NCT03197506?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2018-01-15. Estimated completion is 2028-06-06.
What conditions does trial NCT03197506 study?
This clinical trial studies the following conditions: Glioblastoma, Gliosarcoma, Supratentorial Glioblastoma.
What interventions are being tested in trial NCT03197506?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), External Beam Radiation Therapy (RADIATION), Laboratory Biomarker Analysis (OTHER), Radiation Therapy (RADIATION), Temozolomide (DRUG).
Who is sponsoring clinical trial NCT03197506?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03197506 being conducted?
This trial has 3 study locations across Arizona, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03197506's enrollment target sits among peer trials
52 85th of 199 higher than 114 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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