44
Participants
Start Date
June 30, 2016
Primary Completion Date
July 31, 2020
Study Completion Date
July 31, 2020
Part 1: BO-112
Cohorts of three patients per dose level will be treated consecutively in the absence of Dose Limiting Toxicity (DLT).
Part 2: BO-112
"BO-112 at a fixed dose will be administered as an intratumoral injection for up to 5 doses over 12 weeks and continue as long as there is benefit.~Nivolumab will be administered as an intravenous infusion every 2 weeks at a dose of 3 mg/kg for up to a total period of one year.~OR Pembrolizumab will be administered as an intravenous infusion every 3 weeks at either 200 mg or at 2 mg/kg depending on the indication, for up to a total period of one year."
Hospital General Universitario Gregorio Marañón, Madrid
Hospital Universitario Ramon y Cajal, Madrid
Hospital Universitario 12 de Octubre, Madrid
Hospital Universitario Quiron Madrid, Madrid
Hospital Universitario Virgen de la Victoria, Málaga
Clínica Universitaria Navarra, Pamplona
ICO Hospital Duran i Reynals, Barcelona
Lead Sponsor
Pivotal S.L.
INDUSTRY
Highlight Therapeutics
INDUSTRY