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Phase 3 Randomized, Double-blind, Controlled Study of ICT-107 in Glioblastoma

Study Purpose

ICT-107 consists of dendritic cells, prepared from autologous mononuclear cells that are pulsed with six synthetic peptides that were derived from tumor associated antigens (TAA) present on glioblastoma tumor cells. This is a Phase 3 study to evaluate ICT-107 in patients with newly diagnosed glioblastoma. Subjects will be randomized to receive standard of care chemoradiation (temozolomide (TMZ) with either ICT-107 or a blinded control. Reinfusion with the pulsed dendritic cells should stimulate cytotoxic T cells to specifically target glioblastoma tumour cells.

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:

1. Subjects must understand and sign the study specific informed consent. 2. Subjects must be in primary remission. 3. Subjects should have < 1 cm3 disease by MRI within the previous 4 weeks (by central read) 4. Subjects must be HLA-A2 positive by central lab. 5. Subjects must have adequate renal, hepatic and bone marrow function based on screening laboratory assessments. Baseline hematologic studies and chemistry and coagulation profiles must meet the following criteria: 1. Hemoglobin (Hgb) > 8 g/dL. 2. Absolute Neutrophil Count (ANC) > 1000/mm3. 3. Platelet count > 100,000/mm3. 4. Blood Urea Nitrogen (BUN) < 30 mg/dL. 5. Creatinine < 2 mg/dL. 6. Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2 x upper limit of normal (ULN) 7. Prothrombin Time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6x unless therapeutically warranted. 6. Subjects must use effective contraceptive methods during the study and for three months following the last dose of study product, if of reproductive age and still retain fertility potential. 7. Subjects must have at least one positive DTH skin response (more than 5 mm) to test item challenge prior to randomization.

Exclusion Criteria:

1. Subjects receiving investigational study drug for any indication or immunological-based treatment for any reason (Filgrastim may be used for prevention of severe neutropenia). 2. Subjects with glioblastoma mutated IDH by Immunohistochemistry (IHC) 3. Subjects with concurrent conditions that would jeopardize the safety of the subject or compliance with the protocol. 4. Subjects with a history of chronic or acute hepatitis C or B infection. 5. Subjects require or are likely to require more than a 2-week course of corticosteroids for intercurrent illness. Subjects must have completed the course of corticosteroids at the time of apheresis to meet eligibility. 6. Subjects have any acute infection that requires specific therapy. Acute therapy must have been completed within seven days prior to study enrollment. 7. Subjects with active other malignancy diagnosed in the past 3 years (excepting in situ tumors) 8. Subjects known to be pregnant or nursing.

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.

 NCT02546102
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 3
Lead Sponsor

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

 Precision Life Sciences Group
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 Suspended
Countries Austria, Canada, United States
Conditions

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

 Glioblastoma Multiforme
Additional Details

This is a double blind Phase III study where eligible subjects are randomized into two treatment arms following the SOC primary treatment with chemoradiation: Arm 1 will receive ICT-107 in combination with the standard of care, temozolomide (TMZ), Arm 2 will receive TMZ with a blinded control. A 1:1 randomization will be employed, where ARM 1 will receive ICT-107 and Arm 2 will receive placebo control. All subjects must be HLA-A2+. All subjects must have glioblastoma tissue that has tumor assessment for MGMT methylation status prior to randomization (for stratification). Subjects will have had tumor resection and magnetic resonance imaging (MRI) prior to enrollment into the study. After signing of written informed consent and any required privacy compliance forms and screening, enrolled subjects will undergo large volume apheresis at the study site for collection of PBMCs. Apheresis product will be sent to the manufacturing site where both active therapy (ICT-107) and control will be prepared for each subject prior to randomization The study period consists of 4 time periods; a 6-week Post-Surgery Standard of Care Treatment Phase where subjects receive radiotherapy and TMZ; TMZ and radiation to be initiated no more than 8 weeks after surgical resection of glioblastoma; a Rest Period of no more than 14 days where subjects are reassessed for eligibility, and then randomized; a 4 week Induction Phase where study therapy (ICT-107 or Control) is given weekly; followed by a Maintenance Phase where study therapy is given monthly for 11 months, and then every 6 months until either progression, withdrawal from the study, death, or the supply of autologous study therapy is exhausted. Randomized subjects will receive 4 weekly administrations of subject-specific study therapy (ICT-107 or Control) during the Induction Phase. No TMZ will be given during the 4 week Induction Phase. Each study therapy injection will be delivered intradermally (axilla). The Maintenance Phase will consist of administration of subject-specific study therapy monthly for 11 months after the Induction Phase (for a total of 15 injections over 12 months during the Induction and Maintenance Phases), and then every 6 mos. thereafter until depletion or confirmation of progressive disease (PD). During the Maintenance Phase (where ICT-107 or control are given monthly), the administration of TMZ and subject specific study therapy or control will be separated in time by approximately 2 weeks (see Section 9.1.4). Pre-treatment, treatment and assessment schedules will be the same for all subjects.

Arms & Interventions

Arms

Experimental: 1

Arm 1 will receive ICT-107 in combination with the standard of care, temozolomide (TMZ). ICT-107 will be given once a week for 4 weeks in the induction phase. During the maintenance phase, ICT-107 will be given monthly for the 11 months after induction and once every 6 months thereafter until depletion of supply or confirmation of progressive disease (PD). Administration is intradermal in axilla.

Placebo Comparator: 2

Arm 2 will receive TMZ with a blinded control. Control will be given once a week for 4 weeks in the induction phase. During the maintenance phase, Control will be given monthly for the 11 months after induction and once every 6 months thereafter until depletion of supply or confirmation of progressive disease (PD). Administration is intradermal in axilla.

Interventions

Biological: - ICT-107

Autologous dendritic cells pulsed with peptides associated with tumor antigens

Biological: - Placebo

Control, autologous monocytes-enriched PBMC.

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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Dignity Health - St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013

City of Hope Cancer Center, Duarte, California

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City of Hope Cancer Center

Duarte, California, 91010

UCSD Moores Cancer Center, La Jolla, California

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UCSD Moores Cancer Center

La Jolla, California, 92093

Los Angeles, California

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Southern California Permanente Medical Group

Los Angeles, California, 90027

University of Southern California, Los Angeles, California

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University of Southern California

Los Angeles, California, 90033

Cedars Sinai Medical Center, Los Angeles, California

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Cedars Sinai Medical Center

Los Angeles, California, 90048

Orange, California

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University of California Irvine Chao Family Cancer Center

Orange, California, 92868

Kaiser Permanente, Redwood City, California

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Kaiser Permanente

Redwood City, California, 94063

Kaiser Permanente, Sacramento, California

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Kaiser Permanente

Sacramento, California, 95825

John Wayne Cancer Institute, Santa Monica, California

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John Wayne Cancer Institute

Santa Monica, California, 90404

Stanford Cancer Institute, Stanford, California

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Stanford Cancer Institute

Stanford, California, 95124

University of Colorado Denver, Aurora, Colorado

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University of Colorado Denver

Aurora, Colorado, 80045

Fairfield, Connecticut

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Associated Neurologists of Southern Connecticut

Fairfield, Connecticut, 06824

Smilow Cancer Hospital, New Haven, Connecticut

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Smilow Cancer Hospital

New Haven, Connecticut, 06519

Christiana Care Health Services, Newark, Delaware

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Christiana Care Health Services

Newark, Delaware, 19711

Delray Medical Center, Boca Raton, Florida

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Delray Medical Center

Boca Raton, Florida, 33484

Boca Raton, Florida

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Boca Raton Regional Hospital Lynn Cancer Institute

Boca Raton, Florida, 33486

Piedmont Hospital, Atlanta, Georgia

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Piedmont Hospital

Atlanta, Georgia, 30309

Georgia Regents University, Augusta, Georgia

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Georgia Regents University

Augusta, Georgia, 30912

Northwestern University, Chicago, Illinois

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Northwestern University

Chicago, Illinois, 60611

NorthShore University Health System, Evanston, Illinois

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NorthShore University Health System

Evanston, Illinois, 60201

University of Iowa, Iowa City, Iowa

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University of Iowa

Iowa City, Iowa, 52242

University of Kentucky, Lexington, Kentucky

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University of Kentucky

Lexington, Kentucky, 40536

Norton Cancer Institute, Louisville, Kentucky

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Norton Cancer Institute

Louisville, Kentucky, 40202

Baltimore, Maryland

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Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287

Dana Farber Cancer Institute, Boston, Massachusetts

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Dana Farber Cancer Institute

Boston, Massachusetts, 02114

Massachusetts General Hospital, Boston, Massachusetts

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Massachusetts General Hospital

Boston, Massachusetts, 02114

Boston, Massachusetts

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Harvard Medical School Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

University of Michigan Health System, Ann Arbor, Michigan

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University of Michigan Health System

Ann Arbor, Michigan, 48109

John Nasseff Neuroscience Institute, Minneapolis, Minnesota

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John Nasseff Neuroscience Institute

Minneapolis, Minnesota, 55407

Saint Louis Park, Minnesota

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Metro-Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, 55416

JFK New Jersey Neuroscience Institute, Edison, New Jersey

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Address

JFK New Jersey Neuroscience Institute

Edison, New Jersey, 08820

New Mexico Cancer Care Alliance, Albuquerque, New Mexico

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Address

New Mexico Cancer Care Alliance

Albuquerque, New Mexico, 87131

North Shore University Hospital, Lake Success, New York

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North Shore University Hospital

Lake Success, New York, 11042

Perlmutter Cancer Center, New York, New York

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Perlmutter Cancer Center

New York, New York, 10016

Mount Sinai Medical Center, New York, New York

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Mount Sinai Medical Center

New York, New York, 10029

Columbia University Medical Center, New York, New York

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Columbia University Medical Center

New York, New York, 10032

Weil Cornell Medical Center, New York, New York

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Weil Cornell Medical Center

New York, New York, 10065

University of Rochester Medical Center, Rochester, New York

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University of Rochester Medical Center

Rochester, New York, 14642

Wake Forest University Health Sciences, Winston-Salem, North Carolina

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

The Ohio State University Medical Center, Columbus, Ohio

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The Ohio State University Medical Center

Columbus, Ohio, 43210

Oklahoma City, Oklahoma

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University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

Hershey, Pennsylvania

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Penn State College of Medicine Hershey Medical Center

Hershey, Pennsylvania, 17033

University of Pennsylvania, Philadelphia, Pennsylvania

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University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania

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Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

Pittsburgh, Pennsylvania

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University of Pittsburgh Medical Center Cancer Pavilion

Pittsburgh, Pennsylvania, 15232

Knoxville, Tennessee

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University of Tennessee Medical Cancer Institute

Knoxville, Tennessee, 37920

Texas Oncology, Austin, Texas

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Texas Oncology

Austin, Texas, 78705

Dallas, Texas

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Baylor Health Charles Sammons Cancer Center

Dallas, Texas, 75246

Dallas, Texas

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University of Texas Southwestern Medical Center

Dallas, Texas, 75390

Houston Methodist Hospital, Houston, Texas

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Houston Methodist Hospital

Houston, Texas, 77030

Houston, Texas

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University of Texas Health Science Center Memorial Hermann Hospital

Houston, Texas, 77030

CTRC at UTHSCSA, San Antonio, Texas

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Address

CTRC at UTHSCSA

San Antonio, Texas, 78229

Huntsman Cancer Institute, Salt Lake City, Utah

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Address

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

University of Virginia Health System, Charlottesville, Virginia

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Address

University of Virginia Health System

Charlottesville, Virginia, 22903

Seattle, Washington

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Ivy Center for Advanced Brain Tumor Treatment Swedish Medical Center

Seattle, Washington, 98122

University of Washington Medical Center, Seattle, Washington

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Address

University of Washington Medical Center

Seattle, Washington, 98195

International Sites

Innsbruck, Austria

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Address

Medical University Innsbruck, Dept. of Neurology

Innsbruck, , 6020

Linz, Austria

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Address

Kepler Universitätsklinikum, Neuromed Campus

Linz, , 4020

University Clinic for Neurology, Salzburg, Austria

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Address

University Clinic for Neurology

Salzburg, , 5020

Juravinski Cancer Centre, Hamilton, Ontario, Canada

Status

Address

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2

Princess Margaret Hospital, Toronto, Ontario, Canada

Status

Address

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9

Montreal, Quebec, Canada

Status

Address

Montreal Neurological Institute & Hospital

Montreal, Quebec, H3A2B4

CHUS Service de Neurochirurgie, Sherbrooke, Quebec, Canada

Status

Address

CHUS Service de Neurochirurgie

Sherbrooke, Quebec, J1K2R1

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