Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme
ACT III
A Phase II Study of CDX-110 With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
1 other identifier
interventional
82
1 country
34
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2007
Longer than P75 for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2007
CompletedFirst Posted
Study publicly available on registry
April 11, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJanuary 16, 2018
August 1, 2016
3.3 years
April 10, 2007
January 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival status
5.5mo
Secondary Outcomes (9)
Safety and tolerability characterized by adverse events (term, grade, frequency).
2 years
Safety and tolerability characterized by physical examinations.
2 years
Safety and tolerability characterized by hematologic and metabolic panel (including CBC with differential, electrolytes, BUN, Cr, liver associated enzymes).
2 years
Safety and tolerability characterized by urinalysis.
2 years
Safety and tolerability characterized by vital signs.
2 years
- +4 more secondary outcomes
Study Arms (1)
CDX-110 with GM-CSF
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Newly diagnosed de novo GBM with documented EGFRvIII expression in tumor tissue.
- Gross total resection followed by conventional chemoradiation therapy without progression of disease.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Celldex Investigational Site
Orange, California, 92868, United States
Celldex Investigational Site
San Francisco, California, 94143-0622, United States
Celldex Investigational Site
San Francisco, California, 94143, United States
Celldex Investigational Site
Stanford, California, 94305-5826, United States
Celldex Investigational Site
Stanford, California, 94305, United States
Celldex Investigational Site
New Haven, Connecticut, 06510, United States
Celldex Investigational Site
New Haven, Connecticut, 06519, United States
Celldex Investigational Site
New Haven, Connecticut, 06520, United States
Celldex Investigational Site
Gainesville, Florida, 32610-0277, United States
Celldex Investigational Site
Chicago, Illinois, 60611, United States
Celldex Investigational Site
Evanston, Illinois, 60201, United States
Celldex Investigational Site
Boston, Massachusetts, 02115, United States
Celldex Investigational Site
Lansing, Michigan, 48912, United States
Celldex Investigational Site
Saginaw, Michigan, 48601, United States
Celldex Investigational Site
Saginaw, Michigan, 48604, United States
Celldex Investigational Site
Hackensack, New Jersey, 07601, United States
Celldex Investigational Site
Amherst, New York, 14226, United States
Celldex Investigational Site
New York, New York, 10032, United States
Celldex Investigational Site
New York, New York, 10065, United States
Celldex Investigational Site
Durham, North Carolina, 27710, United States
Celldex Investigational Site
Cincinnati, Ohio, 45219, United States
Celldex Investigational Site
Cincinnati, Ohio, 45267-0502, United States
Celldex Investigational Site
Cincinnati, Ohio, 45267-0769, United States
Celldex Investigational Site
Cleveland, Ohio, 44106, United States
Celldex Investigational Site
Cleveland, Ohio, 44195, United States
Celldex Investigational Site
Orange, Ohio, 44122, United States
Celldex Investigational Site
West Chester, Ohio, 45069-6542, United States
Celldex Investigational Site
Westlake, Ohio, 44145, United States
Celldex Investigational Site
Philadelphia, Pennsylvania, 19104, United States
Celldex Investigational Site
Houston, Texas, 77030, United States
Celldex Investigational Site
San Antonio, Texas, 78229, United States
Celldex Investigational Site
Salt Lake City, Utah, 84112, United States
Celldex Investigational Site
Charlottesville, Virginia, 22908, United States
Celldex Investigational Site
Seattle, Washington, 98195, United States
Related Publications (1)
Schuster J, Lai RK, Recht LD, Reardon DA, Paleologos NA, Groves MD, Mrugala MM, Jensen R, Baehring JM, Sloan A, Archer GE, Bigner DD, Cruickshank S, Green JA, Keler T, Davis TA, Heimberger AB, Sampson JH. A phase II, multicenter trial of rindopepimut (CDX-110) in newly diagnosed glioblastoma: the ACT III study. Neuro Oncol. 2015 Jun;17(6):854-61. doi: 10.1093/neuonc/nou348. Epub 2015 Jan 13.
PMID: 25586468RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2007
First Posted
April 11, 2007
Study Start
August 1, 2007
Primary Completion
November 1, 2010
Study Completion
May 1, 2016
Last Updated
January 16, 2018
Record last verified: 2016-08