4
Participants
Start Date
December 1, 2016
Primary Completion Date
September 22, 2017
Study Completion Date
September 22, 2017
DS-8273a + nivolumab
Nivolumab will be administered at 240 mg intravenously (IV) once every two weeks (Q2W) over 30 (± 5) minutes (on Days 1 and 15 of each cycle of 28 days). DS-8273a will be administered \[90 (± 15) minutes on Day 1 of Cycle 1, and 60 (± 15) minutes in subsequent infusions\] after the end of the nivolumab infusion in ascending doses up to 1200 mg IV Q2W. The regimen is adjusted based on injection site reactions or adverse events. Additional dose combinations may be considered based on the assessment of safety, primary pharmacodynamic (PDy) effects, and preliminary anti-tumor activities.
Georgetown University Medical Center, Washington D.C.
South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids
South Texas Accelerated Research Therapeutics, LLC (START), San Antonio
MD Anderson Cancer Center, Houston
Lead Sponsor
Collaborators (1)
Bristol-Myers Squibb
INDUSTRY
Daiichi Sankyo
INDUSTRY