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

NCT02546102 | Suspended Phase 3 DMC FDA Drug

• 1 other identifier: ICT-107-301
• Study Type: interventional
• Target: 234
• Locations: 3 countries
• Sites: 65

Brief Summary

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.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• Overall survival

  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)

  46 months

Secondary Outcomes (4)

• Overall survival in patients with unmethylated MGMT tumors

  46 months

• Overall survival in patients with methylated MGMT (O6-methylguanine-DNA methyltransferase) tumors

  46 months

• Progression-free survival

  46 months

• Type and frequency of treatment emergent adverse events

  46 months

Study Arms (2)

1

EXPERIMENTAL

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

2

PLACEBO COMPARATOR

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

Interventions

ICT-107 BIOLOGICAL

Autologous dendritic cells pulsed with peptides associated with tumor antigens

1

Placebo BIOLOGICAL

Control, autologous monocytes-enriched PBMC.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must understand and sign the study specific informed consent
• Subjects must be in primary remission
• Subjects should have \< 1 cm3 disease by MRI within the previous 4 weeks (by central read)
• Subjects must be HLA-A2 positive by central lab
• 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:
• Hemoglobin (Hgb) \> 8 g/dL
• Absolute Neutrophil Count (ANC) \> 1000/mm3
• Platelet count \> 100,000/mm3
• Blood Urea Nitrogen (BUN) \< 30 mg/dL
• Creatinine \< 2 mg/dL
• Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \< 2 x upper limit of normal (ULN)
• Prothrombin Time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6x unless therapeutically warranted
• 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.
• Subjects must have at least one positive DTH skin response (more than 5 mm) to test item challenge prior to randomization.

You may not qualify if:

• Subjects receiving investigational study drug for any indication or immunological-based treatment for any reason (Filgrastim may be used for prevention of severe neutropenia).
• Subjects with glioblastoma mutated IDH by Immunohistochemistry (IHC)
• Subjects with concurrent conditions that would jeopardize the safety of the subject or compliance with the protocol.
• Subjects with a history of chronic or acute hepatitis C or B infection.
• 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.
• Subjects have any acute infection that requires specific therapy. Acute therapy must have been completed within seven days prior to study enrollment.
• Subjects with active other malignancy diagnosed in the past 3 years (excepting in situ tumors)
• Subjects known to be pregnant or nursing.

Sponsors & Collaborators

• Precision Life Sciences Group: lead
• Medelis Inc.: collaborator

Study Sites (65)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

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

Phoenix, Arizona, 85013, United States

Location

City of Hope Cancer Center

Duarte, California, 91010, United States

Location

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

Southern California Permanente Medical Group

Los Angeles, California, 90027, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California Irvine Chao Family Cancer Center

Orange, California, 92868, United States

Location

Kaiser Permanente

Redwood City, California, 94063, United States

Location

Kaiser Permanente

Sacramento, California, 95825, United States

Location

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Stanford Cancer Institute

Stanford, California, 95124, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Associated Neurologists of Southern Connecticut

Fairfield, Connecticut, 06824, United States

Location

Smilow Cancer Hospital

New Haven, Connecticut, 06519, United States

Location

Christiana Care Health Services

Newark, Delaware, 19711, United States

Location

Delray Medical Center

Boca Raton, Florida, 33484, United States

Location

Boca Raton Regional Hospital Lynn Cancer Institute

Boca Raton, Florida, 33486, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02114, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Harvard Medical School Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

John Nasseff Neuroscience Institute

Minneapolis, Minnesota, 55407, United States

Location

Metro-Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, 55416, United States

Location

JFK New Jersey Neuroscience Institute

Edison, New Jersey, 08820, United States

Location

New Mexico Cancer Care Alliance

Albuquerque, New Mexico, 87131, United States

Location

North Shore University Hospital

Lake Success, New York, 11042, United States

Location

Perlmutter Cancer Center

New York, New York, 10016, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Weil Cornell Medical Center

New York, New York, 10065, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Penn State College of Medicine Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center Cancer Pavilion

Pittsburgh, Pennsylvania, 15232, United States

Location

University of Tennessee Medical Cancer Institute

Knoxville, Tennessee, 37920, United States

Location

Texas Oncology

Austin, Texas, 78705, United States

Location

Baylor Health Charles Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

CTRC at UTHSCSA

San Antonio, Texas, 78229, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

Location

Ivy Center for Advanced Brain Tumor Treatment Swedish Medical Center

Seattle, Washington, 98122, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Medical University Innsbruck, Dept. of Neurology

Innsbruck, 6020, Austria

Location

Kepler Universitätsklinikum, Neuromed Campus

Linz, 4020, Austria

Location

University Clinic for Neurology

Salzburg, 5020, Austria

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Montreal Neurological Institute & Hospital

Montreal, Quebec, H3A2B4, Canada

Location

CHUS Service de Neurochirurgie

Sherbrooke, Quebec, J1K2R1, Canada

Location

Related Publications (1)

• Phuphanich S, Wheeler CJ, Rudnick JD, Mazer M, Wang H, Nuno MA, Richardson JE, Fan X, Ji J, Chu RM, Bender JG, Hawkins ES, Patil CG, Black KL, Yu JS. Phase I trial of a multi-epitope-pulsed dendritic cell vaccine for patients with newly diagnosed glioblastoma. Cancer Immunol Immunother. 2013 Jan;62(1):125-35. doi: 10.1007/s00262-012-1319-0. Epub 2012 Jul 31.

  PMID: 22847020 RESULT

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2015
• First Posted: September 10, 2015
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

US (58); AU (3); CA (4)