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A Trial Of PF-04856884 In Patients With Recurrent Glioblastoma

Last updated on March 14, 2019

Study Location
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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
to therapy.

- 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

- 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
trial treatment

- 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.

A Trial Of PF-04856884 In Patients With Recurrent Glioblastoma


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