A Phase II, Multi-center, Open-label Study of a Conditionally Replicative Adenovirus (DNX-2401) With Pembrolizumab (KEYTRUDA®) for Recurrent Glioblastoma or Gliosarcoma (CAPTIVE/KEYNOTE-192)

Full Name

A Phase II, Multi-center, Open-label Study of a Conditionally Replicative Adenovirus (DNX-2401) With Pembrolizumab (KEYTRUDA®) for Recurrent Glioblastoma or Gliosarcoma (CAPTIVE/KEYNOTE-192) CAPTIVE: Combination Adenovirus + Pembrolizumab to Trigger Immune Virus Effects

Eligibility

Inclusion Criteria

Inclusion Criteria:

A single glioblastoma or gliosarcoma tumor with histopathological confirmation for first or presenting second recurrence of glioblastoma or gliosarcoma at the time of consent
Gross total or partial tumor resection is not possible or not planned
A single measurable tumor that is at least 10.0 mm longest diameter (LDi) X 10.0 mm shortest diameter (SDi) and this tumor does not exceed 40.0 mm in LDi or SDi
Tumor recurrence or progression documented after previously failing surgical resection, chemotherapy and/or radiation
Karnofsky performance status ≥ 70 %
Prior anti-tumor therapies must have been completed within time periods specified in the protocol prior to DNX-2401 injection

Exc

Exclusion Criteria

Exclusion Criteria:

Multiple (≥ 2) separate enhancing tumors
Tumor location on both sides of the brain and/or involvement that would present the risk of injecting DNX-2401 into the ventricles of the brain
Tumor location in the brain stem
Requires treatment with high-dose systemic corticosteroids within 2 weeks of the start of intravenous pembrolizumab infusions
Uncontrolled blood-sugar levels defined as HbA1c > 7% on 2 separate measurements
Previous treatment with anti-PD1 or PD-L1 agents including pembrolizumab (KEYTRUDA) or any other checkpoint inhibitor(s) (e.g., ipilimumab, nivolumab, etc.)
Evidence of active, non-infectious pneumonitis and/or a history of interstitial lung disease
Prior gene transfer therapy or prior therapy with a cytolytic virus of any type
Brain tumor that is not measurable on MRI or persons who are unable to have MRIs
Pregnant or nursing females