Hypofractionated Stereotactic Irradiation (HFSRT) With Pembrolizumab and Bevacizumab for Recurrent High Grade Gliomas
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|ClinicalTrials.gov Identifier: NCT02313272|
Recruitment Status : Active, not recruiting
First Posted : December 10, 2014
Last Update Posted : August 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma||Radiation: Hypofractionated Stereotactic Irradiation (HFSRT) Drug: Pembrolizumab Drug: Bevacizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Hypofractionated Stereotactic Irradiation (HFSRT) With Pembrolizumab and Bevacizumab in Patients With Recurrent High Grade Gliomas|
|Actual Study Start Date :||May 5, 2015|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2020|
Experimental: HFSRT with Pembrolizumab and Bevacizumab
Hypofractionated Stereotactic Irradiation (HFSRT). Pembrolizumab intravenous (IV) infusion every 3 weeks. Bevacizumab administered intravenously every 2 weeks.
Radiation: Hypofractionated Stereotactic Irradiation (HFSRT)
Radiation therapy treatment (FSRT) which will be given to participants over 5 days.
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.
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.
Other Name: Avastin®
- Maximum Tolerated Dose (MTD) [ Time Frame: Up to 24 months ]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).
- Response Rate (RR) [ Time Frame: Up to 24 months ]Response rate of pembrolizumab given in combination with bevacizumab and hypofractionated stereotactic re-irradiation of recurrent high grade gliomas. Response to treatment will be assessed by the investigator and according to the Response Assessment Criteria for High-Grade Gliomas (RANO Criteria). Brain MRI will be performed every 6 weeks beginning at the end of Week 6 (± 1 week) for 3 cycles and then every 12 weeks (± 1 week) until disease progression or treatment discontinuation, whichever occurs later.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02313272
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Solmaz Sahebjam, M.D.||H. Lee Moffitt Cancer Center and Research Institute|