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NCT02313272 · ClinicalTrials.gov registry record · Phase 1
Hypofractionated Stereotactic Irradiation (HFSRT) With Pembrolizumab and Bevacizumab for Recurrent High Grade Gliomas
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT02313272: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT02313272 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02313272, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of this study is to see if the addition of the investigation drug called pembrolizumab (Keytruda®) to radiation therapy and bevacizumab (Avastin®) is safe and can help with controlling the growth of tumors, in participants with recurrent high grade glioma.
Primary Outcome
The pembrolizumab dose used in the dose expansion cohort will be MTD determined from the dose escalation phase. Dose Escalation: The maximum tolerated dose (MTD) is the highest dose of pembrolizumab in combination with bevacizumab after radiation therapy that does not cause unacceptable toxicity in more than one of six patients at that dose level. The MTD is defined as one dose level below the highest toxic dose (i.e., the Dose Limiting Toxicity (DLT) dose).
Interventions
- DRUG Pembrolizumab
- DRUG Bevacizumab
- RADIATION Hypofractionated Stereotactic Irradiation (HFSRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2015-07-28 |
| Est. Completion | 2021-08-09 |
| Phase | Phase 1 |
What the finished NCT02313272 record still lists
NCT02313272 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT02313272 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02313272 about?
NCT02313272 is a clinical study titled "Hypofractionated Stereotactic Irradiation (HFSRT) With Pembrolizumab and Bevacizumab for Recurrent High Grade Gliomas". The purpose of this study is to see if the addition of the investigation drug called pembrolizumab (Keytruda®) to radiation therapy and bevacizumab (Avastin®) is safe and can help with controlling the growth of tumors, in participants with recurrent high grade glioma.
What is the current status of trial NCT02313272?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2015-07-28. Estimated completion is 2021-08-09.
What interventions are being tested in trial NCT02313272?
The interventions under investigation include: Pembrolizumab (DRUG), Bevacizumab (DRUG), Hypofractionated Stereotactic Irradiation (HFSRT) (RADIATION).
Who is sponsoring clinical trial NCT02313272?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02313272's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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