A Phase II Study of Checkpoint Blockage Immunotherapy in Patients with Somatically Hypermutated Recurrent Glioblastoma

February 23, 2021

Clinical Trial Information

Protocol – Alliance A071702

SCHEMA A071702

Please Note – Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility.

Eligibility:

  1. Histologically confirmed glioblastoma (WHO grade IV) presenting at first or second recurrence including secondary glioblastoma.
  2. Presence of measurable disease, as defined by a bidimensionally measurable lesion on MRI with a minimum diameter of 10 mm in both dimensions, prior to resection or biopsy of recurrent tumor.
  3. Tissue available from surgical resection or biopsy of recurrent tumor ≤14 days prior to pre-registration, or planned surgery or biopsy of recurrent tumor ≤14 days after pre-registration.
  4. Does not require > 4 mg dexamethasone beyond the perioperative period defined as the time ≤ 2 weeks after surgical procedure.
  5. No active autoimmune disease or history of autoimmune disease.
  6. No prior treatment with checkpoint blockade therapies (anti-CTLA4, anti-PD1/PD-L1) or bevacizumab.
  7. Age ≥ 18 years.
  8. ECOG Performance Status ≤ 2.

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