A Study of CDX-1127 (Varlilumab) in Patients With Select Solid Tumor Types or Hematologic Cancers

PHASE1CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

December 31, 2015

Study Completion Date

October 16, 2017

Conditions
CD27 Expressing B-cell Malignancies for Example Hodgkin's LymphomaChronic Lymphocytic LeukemiaMantle Cell LymphomaMarginal Zone B Cell Lymphoma)Any T-cell MalignancySolid Tumors (Metastatic Melanoma, Renal (Clear) Cell CarcinomaHormone-refractory Prostate Adenocarcinoma, Ovarian CancerColorectal Adenocarcinoma, Non-small Cell Lung Cancer)Burkett's LymphomaPrimary Lymphoma of the Central Nervous System
Interventions
DRUG

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."

DRUG

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."

DRUG

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."

Trial Locations (10)

10029

Icahn School of Medicine at Mount Sinai Hess Center for Science and Medicine, New York

19104

University of Pennsylvania Abramson Cancer Center, Philadelphia

22908

University of Virginia Health System, Charlottesville

37203

Sarah Cannon Research Institute, Nashville

43210

The Ohio State University Comprehensive Cancer Center, Columbus

55905

Mayo Clinic, Rochester

75230

Mary Crowley Cancer Research Centers - Medical City, Dallas

85259

Mayo Clinic Arizona - Cancer Clinical Research Unit, Scottsdale

94305

Stanford Cancer Center - Stanford University, Stanford

97239

Oregon Health and Science University, Portland

Sponsors
All Listed Sponsors
lead

Celldex Therapeutics

INDUSTRY

NCT01460134 - A Study of CDX-1127 (Varlilumab) in Patients With Select Solid Tumor Types or Hematologic Cancers | Biotech Hunter | Biotech Hunter