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 range18 Years
SexALL
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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…