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A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma

Study Purpose

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 drug bevacizumab can improve progression free survival (slowing the growth of tumors) of patients with relapsed EGFRvIII positive glioblastoma.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Among other criteria, patients must meet the following conditions to be eligible for the study: 1. Age ≥18 years of age. 2. Histologic diagnosis of glioblastoma (WHO Grade IV). 3. Documented EGFRvlll positive tumor status (central lab confirmation). 4. First or second relapse of de novo glioblastoma or first diagnosis or first relapse of secondary glioblastoma. 5. Previous treatment must include surgery, conventional radiation therapy and temozolomide (TMZ). 6. Screening MRI must be obtained at least 4 weeks after any salvage surgery, and at least 12 weeks after radiation therapy. 7. KPS of ≥ 70%. 8. If applicable, systemic corticosteroid therapy must be at a dose of ≤ 4 mg of dexamethasone or equivalent per day during the week prior to Day 1. 9. Evaluable disease in Groups 1 and 2; measurable disease in Group 2C. 10. Life expectancy > 12 weeks. 11. Patients in Group 2 and 2C must have had disease progression while receiving bevacizumab or within 2 months of treatment with bevacizumab.

Exclusion Criteria:

Among other criteria, patients who meet the following conditions are NOT eligible for the study: 1. Subjects unable to undergo an MRI with contrast. 2. History, presence, or suspicion of metastatic disease. 3. Prior receipt of vaccination against EGFRvIII. 4. Any known contraindications to receipt of study drugs, including 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. 5. Use of non-protein based investigational therapy within 14 days prior to Day 1 or use of antibody-based investigational therapy within 28 days prior to Day 1. 6. Clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment. 7. Evidence of recent hemorrhage on screening MRI of the brain. 8. Evidence of current drug or alcohol abuse. 9. Patients in Group 1 must not have received prior treatment with bevacizumab.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01498328
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Celldex Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Small Cell Glioblastoma, Giant Cell Glioblastoma, Gliosarcoma, Glioblastoma With Oligodendroglial Component, Recurrent Glioblastoma, Relapsed Glioblastoma
Additional Details

This Phase II study will enroll patients into three groups. Group 1 are patients who have never been treated with bevacizumab. These patients will be randomly assigned to receive either rindopepimut/GM-CSF or KLH, each along with bevacizumab. Treatment assignment for Group 1 will be blinded. Group 2 and Group 2C patients are those who are refractory to bevacizumab (experienced recurrence or progression of glioblastoma while on bevacizumab or within 2 months of discontinuing bevacizumab). These patients will all receive rindopepimut/GM-CSF along with bevacizumab. Patients will be treated until disease progression or intolerance and all patients will be followed for survival. Patients may be treated with other therapies that are not part of the study after discontinuing treatment with the study vaccine.

Arms & Interventions

Arms

Experimental: Group 1a: Bevacizumab Naïve with Bevacizumab + rindopepimut.

About half of the patients who have never received treatment with bevacizumab will receive rindopepimut/GM-CSF in a blinded fashion in combination with bevacizumab.

Experimental: Group 1b: Bevacizumab Naïve with Bevacizumab + KLH control

About half of the patients who have never received treatment with bevacizumab will receive KLH in a blinded fashion in combination with bevacizumab.

Experimental: Group 2 and 2C: Refractory to Bevacizumab

Patients with progressive disease while currently on or within two months after discontinuing bevacizumab will be administered rindopepimut/GM-CSF while continuing (or restarting if they had stopped bevacizumab).

Interventions

Drug: - Bevacizumab

A vascular endothelial growth factor (VEGF)-specific humanized monoclonal antibody angiogenesis inhibitor. Infusions of 10 mg/kg of bevacizumab will begin on day 1 and will be administered every two weeks until progression of disease or intolerance during the treatment period.

Drug: - Rindopepimut (CDX-110) with GM-CSF

Rindopepimut/GM-CSF will initially be given three times, two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM-CSF.

Drug: - KLH

KLH will initially be given three times, two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8 mL containing approximately 100 mcg of KLH.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

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University of Alabama at Birmingham

Birmingham, Alabama, 35294

Phoenix, Arizona

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St. Joseph's Hospital and Medical Center / Barrow Neurological Institute

Phoenix, Arizona, 85013

Los Angeles, California

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Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027

Los Angeles, California

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University of Southern California (USC) Norris Comprehensive Cancer Center

Los Angeles, California, 90089

Orange, California

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UC Irvine Chao Family Comprehensive Cancer Center

Orange, California, 92868

University of California San Francisco, San Francisco, California

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University of California San Francisco

San Francisco, California, 94143

Stanford, California

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Stanford Cancer Institute, Stanford University

Stanford, California, 94305

University of Colorado, Denver, Aurora, Colorado

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University of Colorado, Denver

Aurora, Colorado, 80045

Memorial Cancer Institute, Hollywood, Florida

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Memorial Cancer Institute

Hollywood, Florida, 33021

Orlando Health, Inc., Orlando, Florida

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Orlando Health, Inc.

Orlando, Florida, 32806

Tampa General Hospital, Tampa, Florida

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Tampa General Hospital

Tampa, Florida, 33606

Piedmont Atlanta Hospital, Atlanta, Georgia

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Piedmont Atlanta Hospital

Atlanta, Georgia, 30309

Atlanta Cancer Care, Atlanta, Georgia

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Atlanta Cancer Care

Atlanta, Georgia, 30342

Rush University Medical Center, Chicago, Illinois

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Rush University Medical Center

Chicago, Illinois, 60612

University of Chicago, Chicago, Illinois

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University of Chicago

Chicago, Illinois, 60637-1470

NorthShore University Health System, Evanston, Illinois

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NorthShore University Health System

Evanston, Illinois, 60201

The Johns Hopkins Hospital, Baltimore, Maryland

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The Johns Hopkins Hospital

Baltimore, Maryland, 21287

Boston, Massachusetts

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Dana-Farber Cancer Institute and Mass General Hospital

Boston, Massachusetts, 02115

Ann Arbor, Michigan

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University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

Sparrow Cancer Center, Lansing, Michigan

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Sparrow Cancer Center

Lansing, Michigan, 48912

Minneapolis, Minnesota

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John Nasseff Neuroscience Institute, Abbott Northwestern Hospital, 800 e. 28th Str. MR

Minneapolis, Minnesota, 55407

Washington University School of Medicine, Saint Louis, Missouri

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Washington University School of Medicine

Saint Louis, Missouri, 63110

Edison, New Jersey

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New Jersey Neuroscience Institute JFK Medical Center

Edison, New Jersey, 08818

Hackensack University Medical Center, Hackensack, New Jersey

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Hackensack University Medical Center

Hackensack, New Jersey, 07601

Amherst, New York

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Dent Neurologic Institute, 3980 Sheridan Dr, 3rd Flr Clinical Rsch

Amherst, New York, 14226

Commack, New York

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The Long Island Brain Tumor Center at Neurology Surgery, P.C.

Commack, New York, 11725

University of Rochester Medical Center, Rochester, New York

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University of Rochester Medical Center

Rochester, New York, 14642

Stony Brook University Hospital, Stony Brook, New York

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Stony Brook University Hospital

Stony Brook, New York, 11794-8121

Durham, North Carolina

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The Preston Robert Tisch Brain Tumor Center; Duke University Medical Center

Durham, North Carolina, 27710

Wake Forest Baptist Health, Winston-Salem, North Carolina

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Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157

Cincinnati, Ohio

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University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45267

Cleveland, Ohio

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Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106

Cleveland, Ohio

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Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195

Legacy Research Institute, Portland, Oregon

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Legacy Research Institute

Portland, Oregon, 97232

Allentown, Pennsylvania

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Lehigh Valley Hospital-John and Dorothy Morgan Cancer Center

Allentown, Pennsylvania, 18103

University of Pennsylvania, Philadelphia, Pennsylvania

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University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Pittsburgh, Pennsylvania

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University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232

Rhode Island Hospital, Providence, Rhode Island

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Rhode Island Hospital

Providence, Rhode Island, 02903

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee

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Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232

Texas Oncology Midtown, Austin, Texas

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Texas Oncology Midtown

Austin, Texas, 78705

Baylor Research Institute, Dallas, Texas

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Baylor Research Institute

Dallas, Texas, 75246

Houston, Texas

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UT Health Science Center, Houston Memorial Hermann Hospital, 6400 Fannin Street, #2800

Houston, Texas, 77030

Utah Cancer Specialists, Salt Lake City, Utah

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Utah Cancer Specialists

Salt Lake City, Utah, 84116

Swedish Neuroscience Research, Seattle, Washington

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Swedish Neuroscience Research

Seattle, Washington, 98122

University of Washington Medical Center, Seattle, Washington

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Address

University of Washington Medical Center

Seattle, Washington, 98195

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