CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
Pembrolizumab +2 moredrug
Likely dose
Pembrolizumab 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02313272
NCT02313272Phase 1Completed
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A Phase I Trial of Hypofractionated Stereotactic Irradiation (HFSRT) With Pembrolizumab and Bevacizumab in Patients With Recurrent High Grade Gliomas

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Dec 10, 2014·Updated Oct 23, 2023

In Brief

A Phase 1 clinical trial evaluating Hypofractionated Stereotactic Irradiation (HFSRT), Pembrolizumab, and 1 other intervention for Malignant Glioma. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Glioma
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 10, 2014
Enrollment StartJul 28, 2015
Primary CompletionSep 13, 2018
Study CompletionAug 9, 2021
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 11.6 years ago

Interventions

Hypofractionated Stereotactic Irradiation (HFSRT)radiation

Radiation therapy treatment (FSRT) which will be given to participants over 5 days.

Pembrolizumabdrug

Dose Escalation: The dose of pembrolizumab will be escalated per schema in a 3+3 fashion. The starting dose (i.e., dose level 1) will be 100 mg. Dose Expansion: The pembrolizumab dose used in the dose expansion cohort will be maximum tolerated dose (MTD) determined from the dose escalation phase.

Bevacizumabdrug

Initial cycle of bevacizumab must start within 10 days of registering to the trial. It will be given concurrent with radiation therapy. Bevacizumab will be administered intravenously at a dose of 10 mg/kg every 2 weeks. Doses will be adjusted if there is a \> 10% change in weight.