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Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme (ACT III)

This study has been completed.
Information provided by (Responsible Party):
Celldex Therapeutics Identifier:
First received: April 10, 2007
Last updated: August 9, 2016
Last verified: August 2016
This study is designed to evaluate the clinical activity of CDX-110 vaccination when given with standard of care treatment (maintenance temozolomide therapy). Study treatment will be given until disease progression and patients will be followed for long-term survival information. Efficacy will be measured by the progression-free survival status at 5.5 months from the date of first dose.

Condition Intervention Phase
Malignant Glioma
Drug: CDX-110 with GM-CSF
Drug: Temozolomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of CDX-110 With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

Resource links provided by NLM:

Further study details as provided by Celldex Therapeutics:

Primary Outcome Measures:
  • Progression-free survival status [ Time Frame: 5.5mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability characterized by adverse events (term, grade, frequency). [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Safety and tolerability characterized by physical examinations. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Safety and tolerability characterized by hematologic and metabolic panel (including CBC with differential, electrolytes, BUN, Cr, liver associated enzymes). [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Safety and tolerability characterized by urinalysis. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Safety and tolerability characterized by vital signs. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Immune response; T-cell response to vaccine. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Immune response; antibody response to vaccine. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Immune response; HLA typing. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall survival. [ Time Frame: indeterminate ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: August 2007
Study Completion Date: May 2016
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CDX-110 with GM-CSF Drug: CDX-110 with GM-CSF
Three biweekly intradermal injections over four weeks followed by monthly injections until tumor progression. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF.
Other Name: CDX-110 with sargramostim (GM-CSF) (Leukine®)
Drug: Temozolomide
Maintenance temozolomide will begin after completion of the three initial injections of CDX-110 plus GM-CSF. 150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, intolerance or progression.
Other Name: Temodar


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Newly diagnosed de novo GBM with documented EGFRvIII expression in tumor tissue.
  • Gross total resection followed by conventional chemoradiation therapy without progression of disease.

Exclusion Criteria:

  • Presence of diffuse leptomeningeal disease or gliomatosis cerebri.
  • Systemic corticosteroid therapy > 2 mg of dexamethasone or equivalent (as defined by the investigator) per day at study enrollment.
  • Patients who have undergone stereotactic radiosurgery prior to or following surgical resection, or the placement of Gliadel® Wafers.
  • Known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00458601

  Show 34 Study Locations
Sponsors and Collaborators
Celldex Therapeutics
Study Director: Thomas Davis, MD Celldex Therapeutics
  More Information

Responsible Party: Celldex Therapeutics Identifier: NCT00458601     History of Changes
Other Study ID Numbers: CDX110-003 
Study First Received: April 10, 2007
Last Updated: August 9, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Celldex Therapeutics:
EGFRvIII vaccinetemozolomidecancer vaccineimmunotherapy

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on October 25, 2016