90
Participants
Start Date
October 31, 2011
Primary Completion Date
December 31, 2015
Study Completion Date
October 16, 2017
CDX-1127
"Patients will initially receive a single dose of CDX-1127, followed by a 28-day observation period and a Multi-Dose Phase (one cycle of 4 weekly doses of CDX-1127). All patients with stable disease who do not experience a DLT or start alternate anti-cancer treatments may then be eligible for a Retreatment Phase (up to 4 additional cycles). Patients with confirmed partial response or complete response will be followed for response duration and may be eligible for additional cycles of treatment at the time of relapse/progression.~The dose of CDX-1127 given for the Dose Escalation phase will depend on the cohort each patient is assigned to, and will range between 0.1 and 10.0 mg/kg of CDX-1127."
CDX-1127
"Patients will receive 4 weekly doses of CDX-1127 followed by an observation period. All patients with stable disease who do not experience a DLT or start alternate anti-cancer treatments may then be eligible for a Retreatment Phase (up to 4 additional cycles). Patients with confirmed partial response or complete response will be followed for response duration and may be eligible for additional cycles of treatment at the time of relapse/progression."
CDX-1127
"Patients will receive four doses of CDX-1127 administered every three weeks followed by an observation period. All patients with stable disease who do not experience a DLT or start alternate anti-cancer treatments may then be eligible for a Retreatment Phase (up to 4 additional cycles). Patients with confirmed partial response or complete response will be followed for response duration and may be eligible for additional cycles of treatment at the time of relapse/progression."
Icahn School of Medicine at Mount Sinai Hess Center for Science and Medicine, New York
University of Pennsylvania Abramson Cancer Center, Philadelphia
University of Virginia Health System, Charlottesville
Sarah Cannon Research Institute, Nashville
The Ohio State University Comprehensive Cancer Center, Columbus
Mayo Clinic, Rochester
Mary Crowley Cancer Research Centers - Medical City, Dallas
Mayo Clinic Arizona - Cancer Clinical Research Unit, Scottsdale
Stanford Cancer Center - Stanford University, Stanford
Oregon Health and Science University, Portland
Lead Sponsor
Celldex Therapeutics
INDUSTRY