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An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma

Phase 3
18 Years
Open (Enrolling)
Glioblastoma, Small Cell Glioblastoma, Giant Cell Glioblastoma, Gliosarcoma, Glioblastoma With Oligodendroglial Component

Thank you

Trial Information

An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma

The purpose of this research study is to find out whether adding an experimental vaccine
called rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug
temozolomide can help improve the life expectancy of patients with newly diagnosed, resected
EGFRvIII positive glioblastoma.

The duration of participation in this study may be up to 5 years. After you are screened and
enrolled in the study, you will be administered temozolomide and either rindopepimut/GM-CSF
or KLH until either disease progression or intolerance to the medications. If your tumor
progresses while on this study, your doctor may treat you with other therapies that are not
part of the study.

Inclusion Criteria:

Among other criteria, patients must meet the following conditions to be eligible for the

1. Adult patients, ≥ 18 years old

2. Newly diagnosed glioblastoma

3. Attempted surgical resection followed by conventional chemoradiation

4. Documented EGFRvIII positive tumor status by a Sponsor designated laboratory

5. No evidence of progressive disease from the post-operative period to the
post-chemoradiation period

6. Candidate for, and agrees to receive, adjuvant (maintenance) temozolomide therapy

7. Systemic corticosteroid therapy at ≤2 mg of dexamethasone or equivalent per day for
at least 3 days prior to randomization

8. WHO-ECOG Performance Status ≤ 2

9. Patients of childbearing/reproductive potential will be instructed to use birth
control as defined by your doctor.

Exclusion Criteria:

Among other criteria, patients who meet the following conditions are NOT eligible for the

1. Stereotactic biopsy only (without further surgical resection)

2. Presence of diffuse leptomeningeal disease, gliomatosis cerebri, or infratentorial

3. History, presence, or suspicion of metastatic disease

4. Patients who have received any additional treatment for glioblastoma, aside from
surgical resection and chemoradiation with temozolomide

5. Active systemic infection requiring treatment

6. History of any malignancy (other than glioblastoma) during the last three years
except non-melanoma skin cancer, in situ cervical cancer, treated superficial bladder
cancer or cured, early-stage prostate cancer in a patient with PSA level less than
the upper limit of normal

7. Planned major surgery

8. Evidence of current drug or alcohol abuse

9. Known allergy or hypersensitivity to keyhole limpet hemocyanin (KLH), GM-CSF
(sargramostim; LEUKINE®), polysorbate 80 or yeast derived products, or a history of
anaphylactic reactions to shellfish proteins

10. Severe acute or chronic medical or psychiatric condition or laboratory abnormality
that could increase the risk associated with participating in a clinical trial

11. Women who are pregnant of lactating

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

The primary efficacy endpoint of Overall Survival is defined as the number of months from randomization to the date of death (whatever the cause), and will be censored for patients who remain alive at completion of the study for patients with a gross total resection (~n=374). The overall survival of patients will be monitored and compared between the two study arms until the end of the study.

Outcome Time Frame:

During treatment and every three months from end of treatment through end of study or approximately up to 5 years.

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

Related Keywords:

  • Glioblastoma
  • Small Cell Glioblastoma
  • Giant Cell Glioblastoma
  • Gliosarcoma
  • Glioblastoma With Oligodendroglial Component
  • Glioblastoma
  • Small cell
  • Giant cell
  • Gliosarcoma
  • oligodendroglial
  • Brain Cancer
  • Brain Tumor
  • radiotherapy
  • chemoradiation
  • Tumor
  • temozolomide
  • EGFR variant III
  • Glioblastoma
  • Gliosarcoma



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Yale University New Haven, Connecticut  06520
Ohio State University Columbus, Ohio  43210
Dartmouth Hitchcock Medical Center Lebanon, New Hampshire  03756
University of Chicago Chicago, Illinois  60637
USC Norris Comprehensive Cancer Center Los Angeles, California  90089
University of Kentucky Lexington, Kentucky  40536-0098
John Theurer Cancer Center at Hackensack University Medical Center Hackensack, New Jersey  07601
Baylor Research Institute Dallas, Texas  75246
Southeast Nebraska Cancer Center Lincoln, Nebraska  68510
Sarah Cannon Research Institute Nashville, Tennessee  37203
Norton Cancer Institute Louisville, Kentucky  40207
University of California, Davis Sacramento, California  95818
University of Michigan Health System Ann Arbor, Michigan  
Center for Cancer and Blood Disorders, PC Bethesda, Maryland  20817
Swedish Neuroscience Institute Seattle, Washington  98122
Northwestern University Robert H. Lurie Comprehensive Cancer Center Chicago, Illinois  60611-2941
LSU Health Sciences Center, Feist-Weiller Cancer Center Shreveport, Louisiana  71130
City of Hope Cancer Center Duarte, California  91010
Georgia Health Sciences University Augusta, Georgia  30912
Wake Forest Baptist Health Winston-Salem, North Carolina  27157
The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center Durham, North Carolina  27710
University of Wisconsin Paul P Carbone Comprehensive Cancer Center Madison, Wisconsin  53792
UC San Diego Moores Cancer Center La Jolla, California  92093
North Shore University Health System Skokie, Illinois  60077
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center Phoenix, Arizona  85013
San Diego Pacific Oncology & Hematology Associates, Inc Encinitas, California  92024
Stanford Cancer Institute, Stanford University Stanford, California  94305
Mount Sinai Medical Center, Comprehensive Cancer Center Miami Beach, Florida  33140
Winship Cancer Institute, Emory University School of Medicine Atlanta, Georgia  30322
Covenant Clinic / Iowa Spine and Brain Institute Waterloo, Iowa  50702
Edward W. Sparrow Hospital Association - Sparrow Regional Cancer Center Lansing, Michigan  48912
St. Mary's of Michigan Medical Center/Field Neurosciences Institute Saginaw, Michigan  48604
New Jersey Neuroscience Institute, JFK Medical Center Edison, New Jersey  08818
Christiana Care Health Services Newark, New Jersey  19713
Dent Neurosciences Research Institute Amherst, New York  14226
The Long Island Brain Tumor Center at Neurology Surgery, P.C. Great Neck, New York  11021
Columbia University Medical Center - The Neurologic Institute of New York New York, New York  10032
Brain and Spine Surgeons of New York White Plains, New York  10604
University of Cincinnati Cancer Institute Cincinnati, Ohio  45267
University Hospitals, Case Medical Center (Cleveland) Cleveland, Ohio  44106
Providence Portland Medical Center, Oncology & Hematology Care Portland, Oregon  97213
Pacific Neurosurgical Portland, Oregon  97227
Lehigh Valley Physician Group-Hematology-Oncology Associates Allentown, Pennsylvania  18103
West Penn. Allegheny Health System Pittsburg, Pennsylvania  15212
Medical University of South Carolina - Department of Neuroscience Charleston, South Carolina  29425
University of Tennessee Medical Center - Knoxville Knoxville, Tennessee  37920
Texas Oncology Midtwon Austin, Texas  78705
The Methodist Neurological Institute Houston, Texas  77030
University of Utah Department of Neurosurgery Salt Lake City, Utah  84112
University of Virginia Healthcare System Charlottesville, Virginia  22908
University of Arizona Health Network Tucson, Arizona  85724
Kaiser Permanente Hawaii Moanalua Medical Center Honolulu, Hawaii  96819
Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience Institute Minneapolis, Minnesota  55407