Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma



Status:Completed
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/17/2018
Start Date:November 2011
End Date:November 2016

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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

This 2-arm, randomized, phase III study will investigate the efficacy and safety of the
addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer
effects in patients who have tumors that express the EGFRvIII protein) to the current
standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of
brain cancer.

All patients will be administered temozolomide, the standard treatment for glioblastoma. Half
the patients will be randomly assigned to receive rindopepimut and half the patients will be
randomly assigned to receive a control called keyhole limpet hemocyanin.

Patients will be treated in a blinded fashion (neither the patient or the doctor will know
which arm of the study the patient is on). Patients will be treated until disease progression
or intolerance to therapy and all patients will be followed for survival.

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
study:

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
study:

1. Stereotactic biopsy only (without further surgical resection)

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

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,
cured, early-stage prostate cancer in a patient with PSA level less than ULN,or other
carcinoma in situ that has been adequately treated and cured.

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 or lactating
We found this trial at
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1720 2nd Ave S
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3550 Jerome Avenue
Bronx, New York 10467
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5801 South Ellis Avenue
Chicago, Illinois 60637
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Gainesville, Florida 32610
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1924 Alcoa Highway
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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1400 South Orange Avenue
Orlando, Florida 32806
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M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
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601 Elmwood Avenue
Rochester, New York 14642
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1 Tampa General Cir
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Amherst, New York 14226
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
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Annapolis, Maryland 21401
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Baton Rouge, Louisiana 70809
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
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450 Brookline Ave
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506 6th St
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111 Colchester Ave
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1653 W. Congress Parkway
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3310 Live Oak St
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92 2nd St
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80 Seymour St
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1 Medical Center Dr
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Lexington, Kentucky
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1441 Eastlake Ave
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1 Shields Ave
Sacramento, California 95616
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