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| ID | Type | Description | Link |
|---|---|---|---|
| CDX110-003 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDX-110 with GM-CSF | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDX-110 with GM-CSF | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival status | 5.5mo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability characterized by adverse events (term, grade, frequency). | 2 years | |
| Safety and tolerability characterized by physical examinations. | 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celldex Investigational Site | Orange | California | 92868 | United States | ||
| Celldex Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25586468 | Result | 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. |
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|
| Temozolomide | Drug | 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. |
|
|
| 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 |
| Immune response; T-cell response to vaccine. | 2 years |
| Immune response; antibody response to vaccine. | 2 years |
| Immune response; HLA typing. | 2 years |
| Overall survival. | indeterminate |
| 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 |
| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C558237 | rindopepimut |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| C081222 | sargramostim |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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