The purpose of this study is to test the efficacy and safety of an experimental drug, demcizumab, when given in combination with pembrolizumab. Demcizumab is a humanized monoclonal antibody and was developed to target cancer stem cells. Demcizumab may block the growth of cancer stem cells, the remaining cancer cells, and it may also impair the productive growth of new blood vessels, which tumors need to grow and spread. This study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the Sponsor in this consent form.
This is an open-label, Phase 1b dose escalation and expansion study of demcizumab plus pembrolizumab designed to evaluate the safety, efficacy and pharmacokinetics of demcizumab in combination with pembrolizumab in patients with advanced or metastatic solid tumors. This study consists of a screening period, a treatment period and a post-treatment follow up period in which patients will be followed for survival for approximately 12 months. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase. Approximately 42 patients will be enrolled in this study at approximately 10 study centers in the United States (U.S) and Europe.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Drug: Demcizumab at starting dose of 2.5mg/kg administered intravenously (IV).
Drug: Pembrolizumab administered 2mg/kg IV every 3 weeks
Rocky Mountain Cancer Center
Denver, Colorado, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Columbia University Medical Center
New York, New York, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
The START Center for Cancer Care
San Antonio, Texas, United States
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Dose limiting toxicities (DLT) of demcizumab given in combination with pembrolizumab
The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with demcizumab in combination with pembrolizumab
Time frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 1-22)
Pharmacokinetics (PK) of demcizumab and pembrolizumab
peak plasma concentration
Time frame: Plasma sample for Pharmacokinetics (PK) analysis to be obtained on Days 1, 22, 43 then at every other cycle (each cycle is 21 days) until 12 weeks post treatment termination, an average of 1 year
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