drugset / Trial / NCT03478488

Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC

NCT03478488

Phase 3 Active not recruiting 480 enrolled 3D Medicines (Sichuan) Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, open-label, parallel-group multi-center study of Phase 3 study to assess the efficacy and safety of KN035 compared to standard of care (SOC) Gemcitabine-based chemotherapies in the treatment of participants with previously untreated locally advanced or metastatic biliary tract cancer. The primary hypothesis of this study is that participants will have a longer overall Survival (OS) when treated with combined therapy than SOC.

Timeline

Start
2018-04-16
Primary completion
2024-09-10
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Envafolimab Monoclonal antibody 2.5 mg/kg Subcutaneous
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous
Comparator Oxaliplatin Small molecule 85 mg/m2 Intravenous