A Phase I/II, Open-Label, Dose-Escalation Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Occurrence of adverse events (side effects)
12 weeks (1 cycle of study treatment)
Yes
United States: Food and Drug Administration
CDX1401-01
NCT00948961
September 2009
September 2014
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
Mount Sinai Comprehensive Cancer Center | Miami Beach, Florida 33140 |
Henry Ford Health System | Detroit, Michigan 48202 |
Carolina BioOncology Institute, PLLC | Huntersville, North Carolina 28078 |
Providence Portland Cancer Center | Portland, Oregon 97213 |
Weill Cornell Cancer Center | New York, New York 10065 |