This is a single-arm, multi-centre, phase II study in biliary tract cancer (BTC) patients.
The main objective is to detect an increase in progression-free survival rate at 6 months
(according to RECIST version 1.1) from 60% in patients with BTC treated with standard
chemotherapy (CT) approach to 75% when treated with CT combined with pembrolizumab.
Secondary objectives are:
- Assess the treatment efficacy in terms of overall survival, immune related
progression-free survival, response rate (according to RECIST version 1.1), safety,
symptom control and quality of life (QoL) (according to EORTC QoL C30 and BIL 21)
- Exploratory objectives include assessment of immunological response (cytokines,
lymphocyte phenotype, immunoglobulins), and evaluation of pathological and clinical
predictive factors for response/toxicity
- Translational research will focus on biomarkers for prediction of response and toxicity.
Phase:
Phase 2
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC