A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma
Status:
Recruiting
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1/2 study of selinexor in combination with standard of care (SoC) therapy for
newly diagnosed glioblastoma (nGBM) or recurrent glioblastoma (rGBM). This study will be
conducted in 2 phases: a Phase 1a dose finding study followed by Phase 1b (dose expansion)
and a Phase 2 randomized efficacy exploration study and will independently evaluate 3
different combination regimens in 3 treatment arms in patients with nGBM (Arms A and B) or
with rGBM (Arm C).
- Arm A: evaluating the combination of selinexor with radiation therapy (S-RT) in nGBM
participants with uMGMT
- Arm B: evaluating the combination of selinexor with radiation therapy and temozolomide
(TMZ) (S-TRT) in nGBM participants with
methylated-O6-methylguanine-DNA-methyltransferase (mMGMT)
- Arm C: evaluating the combination of selinexor with lomustine (or carmustine, if
lomustine is not available) (S-L/C) in rGBM participants regardless of MGMT status
- Arm D: evaluating the combination of selinexor with bevacizumab in rGBM participants
regardless of MGMT status
- Arm E: evaluating the combination of selinexor with tumor treating fields (TTField) in
rGBM participants regardless of MGMT status