ABOUT THIS STUDY
- Tumor eligibility: Primary Cohort: Measurable disease; Exploratory Cohort: Measurable disease as defined above or non-measurable/evaluable disease (eg, progressing non-enhancing lesions).
- Histologically or cytologically confirmed recurrent GBM in 1st or 2nd relapse: Primary Cohort: Recurrence following radiation therapy and temozolomide, less than or equal to 2 prior chemotherapeutic regimens; Exploratory cohort: Prior radiation therapy, temozolomide, and bevacizumab, Recurrence of disease within 2-4 weeks of last bevacizumab dose.
- Stable dose of corticosteroids for greater than or equal to 5 days prior to baseline Magnetic Resonance Imaging (MRI)
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than or equal to 12 weeks.
- Patients who have previously received a trial drug containing the core platform
antibody (eg, CVX-045, PF-04856884 (CVX-060), CVX-096, PF-05057459 (CVX-241), etc.).
- History of pathologic fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months of therapy.
- Evidence of bleeding diathesis or coagulopathy.
- Major surgical procedure (eg, craniotomy), open biopsy, significant traumatic injury
within 28 days prior to therapy or anticipation of need for a major surgical procedure
during the course of the trial.
- Minor surgical procedures, fine needle aspiration or core biopsies within 7 days prior
- Serious non-healing wound, ulcer, or bone fracture.
- Active gastrointestinal bleeding, as evidenced by either hematemesis, hematochezia, or
melena in prior 6 months.
- Hemoptysis >½ teaspoon per day within 1 week of enrollment.
- National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI CTCAE]
Grade 3 hemorrhage from any cause <4 weeks prior to enrollment.
- Participation in any investigational drug study within 28 days prior to study therapy.
- Evidence of preexisting uncontrolled hypertension
- Clinically significant cardiovascular disease within the 12 months prior to starting
- Prolongation of the QT interval corrected [QTc] interval to >450 msec for men or >470
msec for women.
- History of allergic or anaphylactic reaction to any therapeutic or diagnostic
monoclonal antibody or IgG-fusion protein.
Exclusion Criteria Specific for Primary Cohort
- Prior therapy with bevacizumab or other anti-Vascular Endothelial Growth Factor [VEGF]
agents for the treatment of GBM.
Exclusion Criteria Specific for Exploratory Cohort
- Patients discontinued from prior bevacizumab or anti-VEGF agents due to toxicity.
- Patients who have failed 2 prior anti-VEGF therapies.
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