A Phase 1b Study of Demcizumab Plus Pembrolizumab in Locally Advanced or Metastatic Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02722954|
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : April 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced or Metastatic Solid Tumors||Drug: Demcizumab Drug: Pembrolizumab||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b, Open-Label, Dose Escalation and Expansion Study of Demcizumab Plus Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||May 10, 2017|
|Actual Study Completion Date :||May 19, 2017|
Experimental: Demcizumab and Pembrolizumab
Demcizumab will be administered prior to pembrolizumab
Drug: Demcizumab at starting dose of 2.5mg/kg administered intravenously (IV).
Other Name: OMP-21M18
Drug: Pembrolizumab administered 2mg/kg IV every 3 weeks
- Dose limiting toxicities (DLT) of demcizumab given in combination with pembrolizumab [ Time Frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 1-22) ]The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with demcizumab in combination with pembrolizumab
- Pharmacokinetics (PK) of demcizumab and pembrolizumab [ 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 ]peak plasma concentration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722954
|United States, Colorado|
|Rocky Mountain Cancer Center|
|Denver, Colorado, United States, 80218|
|United States, Michigan|
|University of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109-5848|
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|United States, Tennessee|
|Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|The START Center for Cancer Care|
|San Antonio, Texas, United States, 78229|
|The Royal Marsden NHS Foundation Trust|
|Sutton, Surrey, United Kingdom, SM2 5PT|