121
Participants
Start Date
April 15, 2015
Primary Completion Date
May 3, 2021
Study Completion Date
November 4, 2022
Viagenpumatucel-L
Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
Nivolumab
Nivolumab 240mg IV q2weeks for 18 weeks or until disease progression or unacceptable toxicity. After the completion of 18 weeks of combination therapy, patients may receive either nivolumab dosing schedule listed in the current approved package insert (every 2 weeks or every 4 weeks) per Investigator discretion.
Pembrolizumab
The recommended dose of KEYTRUDA (pembrolizumab) is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
Pemetrexed
The recommended dose of ALIMTA (pemetrexed) when administered with carboplatin and pembrolizumab for the initial treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m2 administered as an intravenous infusion over 10 minutes prior to carboplatin on Day 1 of each 21-day cycle for 4 cycles. Pembrolizumab should be administered prior to ALIMTA when given on the same day.
Winthrop Hospital, Mineola
New York Oncology Hematology, Albany
University of Pennsylvania, Philadelphia
Virginia Cancer Specialists, Fairfax
Memorial Cancer Institute, Pembroke Pines
BRRH Lynn Cancer Institute, Boca Raton
Baptist Health Louisville, Louisville
Ashland-Bellefonte Cancer Center, Ashland
Cleveland Clinic, Cleveland
Oncology Hematology Care, Inc., Cincinnati
Horizon Oncology Research, Lafayette
Washington University School of Medicine, St Louis
University of Arizona Cancer Center, Tucson
UC San Diego, La Jolla
Providence Portland Medical Center, Portland
Rhode Island Hospital, Providence
Lead Sponsor
Heat Biologics
INDUSTRY