BIP_DSP7888-201G

A Randomized, Multicenter, Phase 2 Study of DSP-7888 Dosing Emulsion in Combination with Bevacizumab versus Bevacizumab Alone in Patients with Recurrent or Progressive Glioblastoma following Initial Therapy

Key Inclusion Criteria:
-Histologically confirmed diagnosis of supratentorial GBM (Grade 4 astrocytoma)
-Radiographic evidence of first recurrence or progression of GBM following primary therapy consisting of surgery (biopsy or resection) and chemoradiation; patients may have undergone a second debulking surgery following initial recurrence or progression. Patients whose tumors are O6 methyl guanyl-methyl-transferase (MGMT) methylated-promoter negative need not have received chemotherapy in the past to be eligible
-Human leukocyte antigen type HLA-A*02:01, HLA-A*02:06, or HLA-A*24:02
-Patients must be at least 28 days from any major surgery, and any surgery incisions or wounds must be completely healed
-Patients must be at least 12 weeks from the completion of prior radiation therapy (RT) in order to discriminate pseudo progression of disease from progression
-Patients must be at least 4 weeks from the completion of prior systemic or intracranial chemotherapy

Key Exclusion Criteria:
-Prior therapy with Bev
-Any anti-neoplastic therapy, including RT, for first relapse or recurrence
-The need for systemic glucocorticoids in doses in excess of 4 mg/day of dexamethasone or in comparable doses with other glucocorticoids
-Prior history of malignancy within 3 years of enrollment other than basal or squamous cell carcinoma of the skin, cervical intra-epithelial neoplasia, in situ carcinoma of the breast, or prostate cancer treated with surgery or RT with a prostate specific antigen of <0.01 ng/mL
-Patients with active autoimmune diseases within 2 years of enrollment into the study including, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, Sjogren's syndome, Wegener's granulomatosis, ulcerative colitis, Crohn's disease, myasthenia gravis, Graves' disease, or uveitis except for psoriasis not requiring systemic therapy, vitiligo or alopecia areata, or hypothyroidism; if an autoimmune condition has been clinically silent for 12 months or greater, the patient may be eligible for enrollment

**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Phase II
NCT03149003
Neurosciences
Neuro-oncology
Ricky Chen, M.D.
Boston Biomedical
Kyla Lindberg
  • Providence St. Vincent Medical Center