315
Participants
Start Date
August 28, 2017
Primary Completion Date
February 13, 2023
Study Completion Date
February 14, 2023
NIR178
"NIR178, a new, non-xanthine based compound, is a potent oral adenosine A2a receptor against antagonist being developed by Novartis.~NIR178 was administered orally twice daily (BID) as a capsule (Part 1, Part 2 and Japanese safety run-in) and as a film-coated table (Part 3). There were up to 3 dose levels assessed: 80, 160 and 240 mg. Three alternative dosing schedules were evaluated: continuous (Part 1, Part 2, Part 3, Japanese safety run-in), 2 weeks on/2 weeks off (Part 2) and 1 week on/1 week off (Part 2).~Each cycle consisted of 28 days."
PDR001
PDR001 is a human monoclonal antibody (MAb) administered on Day 1 of each cycle. PDR001 400 mg was administered via intravenous (i.v.) infusion over 30 minutes every 4 weeks (Q4W).
Novartis Investigative Site, Blacktown
Novartis Investigative Site, Liège
Novartis Investigative Site, Salzburg
Novartis Investigative Site, Sankt Gallen
Novartis Investigative Site, Taipei
Novartis Investigative Site, Marseille
Novartis Investigative Site, Milan
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore
H Lee Moffitt Cancer Center and Research Institute ., Tampa
Novartis Investigative Site, Essen
Novartis Investigative Site, Cologne
The University of Wisconsin, Madison
MD Anderson Cancer Center/University of Texas, Houston
Novartis Investigative Site, Napoli
University of California, Los Angeles, Santa Monica
Novartis Investigative Site, Singapore
Novartis Investigative Site, CABA
Novartis Investigative Site, Brno
Novartis Investigative Site, Koto Ku
Novartis Investigative Site, Rotterdam
Novartis Investigative Site, Barcelona
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY