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NCT03405792 · ClinicalTrials.gov registry record · Phase 2
Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP)
A Phase 2 study of Glioblastoma and Glioblastoma WHO Grade IV, sponsored by University of Florida.
- Active
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03405792: Active Phase 2 study of Glioblastoma and Glioblastoma WHO Grade IV, sponsored by University of Florida.
NCT03405792 is a Phase 2 study of Glioblastoma and Glioblastoma WHO Grade IV that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 40 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03405792, a Phase 2 study of Glioblastoma and Glioblastoma WHO Grade IV, is active but no longer recruiting, sponsored by University of Florida.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Glioblastoma multiforme (GBM) is the most common and deadliest primary malignant neoplasm of the central nervous system in adults. Despite an aggressive multimodality treatment approach including surgery, radiation therapy and chemotherapy, overall survival remains poor. Pembrolizumab has recently been approved in the United States for the treatment of patients with advanced and metastatic non-small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma, locally advanced urothelial carcinoma, classical Hodgkin lymphoma, unresectable or metastatic melanoma This study is being performed to determine whether the triple combination of pembrolizumab when added to TTFields (Optune®) and adjuvant temozolomide increases progression-free survival (PFS) in patients with newly diagnosed GBM as compared to historical control data.
Primary Outcome
Time from enrollment to progression or death or censoring, whichever occurs first. The study team will use the one-sample log-rank test to compare PFS in the triple combination arm relative to the historical control arm to determine whether the triple combination treatment increases PFS in newly diagnosed GBM patients when compared to TTFields+TMZ historical control patients from the EF-14 study. Evaluability for progression free survival required participants to receive adjuvant TMZ, Optune and
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Temozolomide (TMZ)
- DEVICE Optune System
Study Locations (1)
Florida
- University of Florida Health - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-02-23 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What the registry record for NCT03405792 still lists
NCT03405792 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (63% lower).
The record links to 2 conditions, with Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03405792 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03405792 about?
NCT03405792 is a clinical study titled "Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP)". Glioblastoma multiforme (GBM) is the most common and deadliest primary malignant neoplasm of the central nervous system in adults. Despite an aggressive multimodality treatment approach including surgery, radiation therapy and chemotherapy, overall survival remains poor. Pembrolizumab has recently b...
What is the current status of trial NCT03405792?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2018-02-23. Estimated completion is 2027-12.
What conditions does trial NCT03405792 study?
This clinical trial studies the following conditions: Glioblastoma, Glioblastoma WHO Grade IV.
What interventions are being tested in trial NCT03405792?
The interventions under investigation include: Pembrolizumab (DRUG), Temozolomide (TMZ) (DRUG), Optune System (DEVICE).
Who is sponsoring clinical trial NCT03405792?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03405792 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03405792's enrollment target sits among peer trials
40 103rd of 199 higher than 94 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
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