17
Participants
Start Date
May 31, 2015
Primary Completion Date
August 31, 2017
Study Completion Date
November 3, 2017
Combination of varlilumab and sunitinib
"During the treatment phase of the study, eligible patients will receive varlilumab for up to 8 cycles. Treatment cycles are 6 weeks each with varlilumab administered once every 3 weeks and sunitinib administered daily for 4 weeks followed by a 2 week rest. There is no limit on the number of cycles of sunitinib. Patients may be discontinued from receiving study treatment (sunitinib or varlilumab) based on the results of disease assessments or if experiencing side effects that make study therapy intolerable.~Phase l Dose: The planned dose of varlilumab will be dependent on the cohort assigned at enrollment. Varlilumab doses are 0.3 mg/kg, 1 mg/kg or 3 mg/kg.~The Study was terminated prior to initiation of Phase II.~All patients will receive sunitinib at a dose of 50 mg."
Mount Sinai Medical Center, New York
Thomas Jefferson University, Philadelphia
George Washington University-Medical Faculty Associates, Washington D.C.
University of Alabama at Birmingham, Birmingham
University of Michigan, Ann Arbor
Barbara Ann Karmanos Cancer Institute, Detroit
Nebraska Cancer Specialists, Omaha
UCSF Helen Diller Comprehensive Cancer Center, San Francisco
UC Davis Comprehensive Cancer Center, Sacramento
Lead Sponsor
Celldex Therapeutics
INDUSTRY