33
Participants
Start Date
April 19, 2016
Primary Completion Date
May 8, 2018
Study Completion Date
March 3, 2023
Axitinib
5 mg tablets twice daily oral dose administered for 7 consecutive weeks on Cycle 1. A safety lead-in consisting of the initial five patients, intrapatient dose escalation of Axitinib will be permitted based on the absence of predefined toxicities. Twice daily oral dose between 2 mg to 10 mg Axitinib tablets will be administered on subsequent 6 week cycles until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Pembrolizumab
200 mg intravenous infusion administered every 21 weeks beginning week 2 of Cycle 1 for a maximum of up to 2 years or until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
University of Miami, Miami
Collaborators (1)
Merck Sharp & Dohme LLC
INDUSTRY
Pfizer
INDUSTRY
Jonathan Trent, MD, PhD
OTHER