Advanced Malignancies Clinical Trial
Official title:
A Phase I/II, Open-Label, Dose-Escalation Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1
The main purpose of this study is to examine the safety and tolerability of CDX-1401 when given in combination with an immune stimulant (resiquimod) to patients with advanced cancers that are known to express the NY-ESO-1 protein.
NY-ESO-1 is a protein that is often made by some types of tumor cells, but only made by a
few types of normal cells. Because it is primarily made by cancer cells, the NY-ESO-1
protein is a promising target against which to stimulate an immune response that may destroy
cancer cells. CDX-1401 is a cancer vaccine that is specially designed to create this type of
immune response. To enhance the immune response, CDX-1401 will be given with 1 or 2 immune
stimulants called Resiquimod and poly-ICLC (Hiltonol).
This clinical trial includes Phase 1 and Phase 2 segments. During the Phase 1 segment, six
groups of 6 to 24 patients will be treated with different dose levels of CDX-1401 in
combination with either one or both of the immune stimulants (Resiquimod and/or poly-ICLC).
This phase of the study will test the safety profile of the vaccine treatment, and will
assess which dose to test in future studies. During the Phase 2 segment, 14 patients whose
cancer tested positive for the NY-ESO-1 protein in laboratory testing, will receive the
study treatment to determine if it has an effect on their cancer. All patients enrolled in
either part of the study may continue to receive study treatment until their disease has
progressed or until it is necessary to stop the treatment for safety or other reasons. In
addition, all patients will be "followed" for 24 months after enrollment in order to collect
survival information.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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