CDX-110 : Phase II Extension

A Complementary Trial of an Immunotherapy Vaccine Against Tumor-Specific EGFRvIII (Activate Trial)

About the Clinical Trial

This is an ongoing investigator-initiated trial being conducted at the Brain Tumor Center at the Duke Comprehensive Cancer Center and at the M.D. Anderson Cancer Center in Houston, Texas.  This trial is evaluating the safety, immune response, anticancer activity, and impact on survival of the addition of CDX-110 vaccine to standard of care in patients with glioblastoma multiforme.

Twenty three patients have previously been enrolled in the first stage of this trial, with encouraging results. CDX-110 was well tolerated and immune responses were generated. Median time to disease progression was 12.8 months, comparing favorably with a matched historical cohort (7.1 months) and published reports using standard of care temozolomide chemotherapy (6.9 months). Median survival in this trial has not yet been reached at 18 months, again comparing favorably to the matched historical cohort (13 months) and the standard of care therapy group (14.6 months). 

In the ongoing second stage of this study, a total of 22 patients will receive maintenance chemotherapy (with temozolomide) plus intradermal injections of CDX-110 on a biweekly to monthly basis, continuing until progression of disease.

Patient Eligibility

Major entry criteria include:

• Newly diagnosed glioblastoma multiforme which expresses EGFRvIII (screening is included in pre-study evaluation)
• Previous successful gross tumor resection (less than 1 cm² residual disease)
• Eligible for or have received standard chemoradiation with temozolomide without progression of disease

For more information on enrollment, please contact:
Dr. John Sampson, Duke University Medical Center - Telephone: (919) 684-9041
The MD Anderson Information Line at 713-792-3245