refractory, advanced gastro-oesophageal cancer
Conditions
Brief summary
Overall survival (OS) (death from any cause) in the overall study population
Detailed description
Overall survival (death from any cause) in the Asian sub-population, Progression free survival (PFS) (disease progression or death), Objective tumour response rate (OTRR) (partial or complete response (PR or CR)) according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, and immune-related iRECIST, Quality of life (QoL) (scores from participant-completed questionnaires), Safety (rates of adverse events), Translational Research: prognostic and predictive biomarkers (tissue and circulating) for study endpoints (relating to survival, response and safety), Translational Research: regorafenib PK in patient populations from different geographical regions (PK levels)
Interventions
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGBAY 734506
Sponsors
Institut fuer Klinische Krebsforschung IKF GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) (death from any cause) in the overall study population | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (death from any cause) in the Asian sub-population, Progression free survival (PFS) (disease progression or death), Objective tumour response rate (OTRR) (partial or complete response (PR or CR)) according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, and immune-related iRECIST, Quality of life (QoL) (scores from participant-completed questionnaires), Safety (rates of adverse events), Translational Research: prognostic and predictive biomarkers (tissue and circulating) for study endpoints (relating to survival, response and safety), Translational Research: regorafenib PK in patient populations from different geographical regions (PK levels) | — |
Countries
Austria, Germany, Italy, Spain
Outcome results
None listed