Nivolumab With Radiation Therapy and Bevacizumab for Recurrent MGMT Methylated Glioblastoma (NCT03743662) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Nivolumab With Radiation Therapy and Bevacizumab for Recurrent MGMT Methylated Glioblastoma
United States39 participantsStarted 2018-11-12
Plain-language summary
This study is being done to see if adding nivolumab to radiation therapy and bevacizumab can increase the effectiveness of the treatment for recurrent glioblastoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologic confirmed glioblastoma (WHO grade IV), IDH wildtype confirmed by DNA sequencing
* MGMT hypermethylation in archival tumor biopsy, determined by any CLIAapproved, DNA-based assay
* Prior maximal feasible surgical resection of biopsy
* Prior treatment with radiation and temozolomide chemotherapy
* Pathologic and/or Radiographic evidence of recurrent disease
* Circumscribed enhancing tumor ≤ 5.0 cm in largest diameter (T1 post contrast)
* 1 prior course of radiation therapy
* Age ≥ 18 years
* Karnofsky performance status ≥ 70% or ECOG 0 or 1
* Adequate bone marrow function
* Hemoglobin ≥ 10g/dL
* Absolute neutrophil count ≥ 1,500/mm 3
* Absolute lymphocyte count ≥ 200/mm 3
* Platelet count ≥ 100,000/mm3
* Adequate liver function
* Bilirubin \<1.5 times upper limit normal (ULN)
* AST and ALT ≤ 3 times ULN
* Alkaline phosphatase ≤ 2 times ULN
* Adequate renal function
* BUN and Creatinine \<1.5 times ULN
Exclusion Criteria:
* Infratentorial location of the recurrence
* IDH mutated glioblastoma
* More than one prior tumor recurrence after standard first-line therapy
* Prior radiation to the brain within ≤ 4 months
* Circumscribed enhancing tumor \>5.0 cm in largest diameter (T1 post contrast)
* Pulmonary embolus or deep vein thrombosis within preceding 2 months
* Grade 2 or greater congestive heart failure
* Unstable angina, myocardial infarction within past 12 months
* Peptic ulcer, abdominal fistula, gastrointestinal perforat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines nivolumab, radiation therapy, and bevacizumab for recurrent glioblastoma where the tumor has MGMT methylation — does my tumor have that specific methylation status, and would that make this combination worth discussing for my situation?
2Since this is a Phase 2 trial measuring overall survival, what does that mean about how much is already known versus still being studied when it comes to the safety and potential benefit of this three-drug-plus-radiation approach?
3The trial is listed as active but no longer recruiting new patients — is there any possibility of accessing this treatment combination outside the trial, or through a compassionate use or expanded access program?
4How does recurrent glioblastoma respond differently to re-irradiation combined with immunotherapy like nivolumab compared to standard options at recurrence, and what would my doctor expect the realistic trade-offs to be?
5Given that bevacizumab is already an approved treatment for recurrent glioblastoma on its own, is there a reason to consider this combination trial over starting bevacizumab alone as a next step in my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.