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

This study has suspended participant recruitment.
(Company at this time unable to secure sufficient financial resources to complete)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02546102
First Posted: September 10, 2015
Last Update Posted: June 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novella Clinical
Information provided by (Responsible Party):
ImmunoCellular Therapeutics, Ltd.
  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.

Condition Intervention Phase
Glioblastoma Multiforme Biological: ICT-107 Biological: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized Double-blind, Controlled Study of ICT-107 With Maintenance Temozolomide (TMZ) in Newly Diagnosed Glioblastoma Following Resection and Concomitant TMZ Chemoradiotherapy

Resource links provided by NLM:


Further study details as provided by ImmunoCellular Therapeutics, Ltd.:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 46 months ]
    Overall survival (OS) of subjects treated with ICT-107 and standard of care (radiation (RT) and TMZ) vs. placebo control and standard of care (RT and TMZ)


Secondary Outcome Measures:
  • Overall survival in patients with unmethylated MGMT tumors [ Time Frame: 46 months ]
    OS of subjects with unmethylated MGMT (O6-methylguanine-DNA methyltransferase) tumors treated with ICT-107 and standard of care vs. control and standard of care

  • Overall survival in patients with methylated MGMT (O6-methylguanine-DNA methyltransferase) tumors [ Time Frame: 46 months ]
    OS of subjects with methylated MGMT tumors treated with ICT-107 and standard of care vs. control and standard of care.

  • Progression-free survival [ Time Frame: 46 months ]
    Progression-free survival (PFS) of subjects treated with ICT-107 and standard of care vs. control and standard of care

  • Type and frequency of treatment emergent adverse events [ Time Frame: 46 months ]
    Compare the type and frequency of treatment emergent adverse events of ICT-107 vs. control treatment groups


Estimated Enrollment: 414
Study Start Date: December 2015
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: ICT-107
Autologous dendritic cells pulsed with peptides associated with tumor antigens
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.
Biological: Placebo

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546102


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Dignity Health - St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
City of Hope Cancer Center
Duarte, California, United States, 91010
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
Southern California Permanente Medical Group
Los Angeles, California, United States, 90027
University of Southern California
Los Angeles, California, United States, 90033
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
University of California Irvine Chao Family Cancer Center
Orange, California, United States, 92868
Kaiser Permanente
Redwood City, California, United States, 94063
Kaiser Permanente
Sacramento, California, United States, 95825
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
Stanford Cancer Institute
Stanford, California, United States, 95124
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Connecticut
Associated Neurologists of Southern Connecticut
Fairfield, Connecticut, United States, 06824
Smilow Cancer Hospital
New Haven, Connecticut, United States, 06519
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19711
United States, Florida
Delray Medical Center
Boca Raton, Florida, United States, 33484
Boca Raton Regional Hospital Lynn Cancer Institute
Boca Raton, Florida, United States, 33486
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Georgia Regents University
Augusta, Georgia, United States, 30912
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
NorthShore University Health System
Evanston, Illinois, United States, 60201
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02114
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Harvard Medical School Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
John Nasseff Neuroscience Institute
Minneapolis, Minnesota, United States, 55407
Metro-Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States, 55416
United States, New Jersey
JFK New Jersey Neuroscience Institute
Edison, New Jersey, United States, 08820
United States, New Mexico
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States, 87131
United States, New York
North Shore University Hospital
Lake Success, New York, United States, 11042
Perlmutter Cancer Center
New York, New York, United States, 10016
Mount Sinai Medical Center
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
Weil Cornell Medical Center
New York, New York, United States, 10065
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Penn State College of Medicine Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh Medical Center Cancer Pavilion
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
University of Tennessee Medical Cancer Institute
Knoxville, Tennessee, United States, 37920
United States, Texas
Texas Oncology
Austin, Texas, United States, 78705
Baylor Health Charles Sammons Cancer Center
Dallas, Texas, United States, 75246
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Houston Methodist Hospital
Houston, Texas, United States, 77030
University of Texas Health Science Center Memorial Hermann Hospital
Houston, Texas, United States, 77030
CTRC at UTHSCSA
San Antonio, Texas, United States, 78229
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
United States, Washington
Ivy Center for Advanced Brain Tumor Treatment Swedish Medical Center
Seattle, Washington, United States, 98122
University of Washington Medical Center
Seattle, Washington, United States, 98195
Austria
Medical University Innsbruck, Dept. of Neurology
Innsbruck, Austria, 6020
Kepler Universitätsklinikum, Neuromed Campus
Linz, Austria, 4020
University Clinic for Neurology
Salzburg, Austria, 5020
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Montreal Neurological Institute & Hospital
Montreal, Quebec, Canada, H3A2B4
CHUS Service de Neurochirurgie
Sherbrooke, Quebec, Canada, J1K2R1
Sponsors and Collaborators
ImmunoCellular Therapeutics, Ltd.
Novella Clinical
  More Information

Publications:
Responsible Party: ImmunoCellular Therapeutics, Ltd.
ClinicalTrials.gov Identifier: NCT02546102     History of Changes
Other Study ID Numbers: ICT-107-301
First Submitted: September 7, 2015
First Posted: September 10, 2015
Last Update Posted: June 23, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents