Hypofractionated Stereotactic Irradiation With Nivolumab, Ipilimumab and Bevacizumab in Patients With Recurrent High Grade Gliomas
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|ClinicalTrials.gov Identifier: NCT02829931|
Recruitment Status : Recruiting
First Posted : July 12, 2016
Last Update Posted : August 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma||Radiation: Hypofractionated Stereotactic Irradiation Drug: Nivolumab Drug: Bevacizumab Drug: Ipilimumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Hypofractionated Stereotactic Irradiation (HFSRT) Combined With Nivolumab, Ipilimumab and Bevacizumab in Patients With Recurrent High Grade Gliomas|
|Actual Study Start Date :||August 9, 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2021|
Experimental: Combination Therapy
Safety Cohort: The first 6 participants will receive Hypofractionated Stereotactic Irradiation (HFSRT) followed by Ipilimumab + Nivolumab + Bevacizumab.
Dose Expansion Cohort: All 26 participants will be treated with Hypofractionated Stereotactic Irradiation (HFSRT), followed by Ipilimumab + Nivolumab +Bevacizumab
Radiation: Hypofractionated Stereotactic Irradiation
Hypofractionated Stereotactic Irradiation (HFSRT) prior to nivolumab.
Nivolumab intravenously (IV): 240 mg every (q) 3 weeks x 4 months followed by 480 mg X 4 months.
Other Name: OPDIVO
Bevacizumab intervenously (IV): 15 mg/kg every (q) 3 weeks when given with Ipilumumab and Nivolumab combination. Dose changed to 10mg/kg every 2 weeks when given with Nivolumab only.
Other Name: Avastin
Ipilimumab 1mg/kg intervenously (IV) 200 mg (5 mg/mL) every (q) 3 weeks for 4 months.
Other Name: Yervoy
- Number of Participants with Treatment Related Adverse Events [ Time Frame: Up to 24 months ]Safety and tolerability of nivolumab, given in combination with hypofractionated stereotactic re-irradiation of recurrent high grade gliomas.
- Response Rate [ Time Frame: Up to 36 months ]All participants will receive efficacy assessments with brain MRI at time points specified in Trial Flow Chart. Cases of suspected radiologic disease progression will be confirmed by an MRI performed approximately 8 weeks after the initial radiological assessment of progression. Immunotherapy Response Assessment in Neuro-Oncology (iRANO) and Response Assessment Criteria for High-Grade Gliomas (RANO Criteria) will be used for assessing the response to study treatment.
- Overall Survival (OS) Rate at 6 Months [ Time Frame: 6 months ]OS, utilizing 95% confidence interval (95%CI).
- Overall Survival (OS) Rate at 9 Months [ Time Frame: 9 months ]OS, utilizing 95% confidence interval (95%CI).
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): NCT02829931
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Melissa Wicklund 813-745-3620 email@example.com|
|Contact: Solmaz Sahebjam 813-745-6101 firstname.lastname@example.org|
|Principal Investigator: Solmaz Sahebjam, M.D.|
|Sub-Investigator: John A. Arrington, M.D.|
|Sub-Investigator: Peter Forsyth, M.D.|
|Sub-Investigator: Peter A. Johnstone, M.D.|
|Sub-Investigator: Nam D. Tran, M.D., Ph.D.|
|Sub-Investigator: H. Michael Yu, M.D.|
|Sub-Investigator: Sepideh Mokhtari, M.D.|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Not yet recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Raju Raval 614-685-2435|
|Principal Investigator: Raju Raval, M.D.|
|Principal Investigator:||Solmaz Sahebjam, M.D.||H. Lee Moffitt Cancer Center and Research Institute|