CDX-110 : Clinical Program

Clinical Program for Malignant Glioblastoma (GBM)

CDX-110 is an immunotherapy that targets the tumor specific molecule called EGFRvIII, a functional variant of the epidermal growth factor receptor (EGFR), a protein that has been well validated as a target for cancer therapy. Unlike EGFR, EGFRvIII is not present in normal tissues, suggesting this target will enable the development of a tumor-specific therapy for cancer patients. Furthermore, EGFRvIII is a transforming oncogene that can directly contribute to the cancer cell growth. While originally discovered in glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer, the expression of EGFRvIII has also been observed in various other cancers such as breast, ovarian, metastatic prostate, colorectal, and head & neck cancers.

ACTIVATE and ACT II Clinical Trials

The initial clinical development of EGFRvIII immunotherapy was led by collaborating investigators at the Brain Tumor Center at the Duke Comprehensive Cancer Center (Durham, NC) and at the M.D. Anderson Cancer Center (Houston, Texas). The investigators enrolled patients with newly diagnosed GBM into 2 studies: CDX-110 vaccine alone (the “ACTIVATE” study) or CDX-110 plus temozolomide (the “ACT II” study). The results of these studies have demonstrated a significant increase in the time to disease progression and overall survival relative to appropriately matched historical controls. The therapy has been well tolerated and significant immune responses to EGFRvIII were generated. The only frequently observed side effect was inflammation at the injection site. Importantly, 21/24 relapsed tumors that were biopsied or resected were found to no longer have significant EGFRvIII expression, suggesting a potent immune rejection of EGFRvIII expressing tumor cells. Click here for a summary of updated data from these studies.

ACT III Clinical Trial

In collaboration with our partner, Pfizer, Celldex is currently performing a Phase 2 study (the “ACT III” study) of CDX-110 in patients with newly diagnosed GBM. Objectives of the study are to investigate the anticancer activity, impact on survival, and safety of CDX-110 when administered during a 12 month course of maintenance temozolomide chemotherapy and then continuing until disease progression. Approximately 60 patients will receive CDX-110 as part of this study.



A Phase 2 Open-label Study of CDX-110 with Radiation and Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme

Currently Enrolling
Phase 2: Newly Diagnosed Glioblastoma Multiforme (GBM) with EGFRvIII Expression
Design: Open-label, multi-institution study of CDX-110 with radiation and standard of care treatment (maintenance temozolomide therapy)
Status: Currently enrolling at multiple centers across North America


Patient Eligibility

Major entry criteria include:

  • Newly diagnosed glioblastoma multiforme that expresses EGFRvIII (screening is included in pre-study evaluation) in patients 18 years of age or older
  • Previous successful gross tumor resection (less than 1 cm2 residual disease) followed by standard radiotherapy with concurrent temozolomide
  • No evidence of disease progression

Please click here for more information about this trial, including a list of clinical trial sites and contact information for prospective patients.

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