El estudio consistió en una parte abierta de incorporación de seguridad y una parte aleatorizada, doble ciego y controlada con placebo de Fase 2/3. En la parte de Fase 2/3 se evaluó si bintrafusp alfa en combinación con el tratamiento estándar vigente (gemcitabina más cisplatino) mejora la supervivencia global (SG) en participantes con cáncer de vías biliares (CVB) localmente avanzado o metastásico, naïve a quimioterapia e inmunoterapia, en comparación con placebo, gemcitabina y cisplatino.
Participants received intravenous infusion of M7824 at a dose of 2400 milligrams (mg), once every 3 weeks (Q3W) 2 years (in case of Complete Response), otherwise until criterion pre-sepcified in protocol for discontinuation is met, in combination with intravenous infusion of Gemcitabine and Cisplatin at a dose of 1000 milligram per meter square (mg/m\^2) and 25 mg/m\^2 respectively on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks.
Participants received intravenous infusion of M7824 matched placebo, once every 3 weeks (Q3W) until 2 years (in case of CR), otherwise until crtiterion pre-sepcified in protocol for discontinuation is met.
Gemcitabine was received intravenously at a dose of 1000 milligram per meter square (mg/m\^2) on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks (Q3W).
Cisplatin was received intravenously at a dose of 25 mg/m\^2 on Day 1 and Day 8 of 21-day cycle, for 8 cycles every 3 weeks (Q3W).
Ciudad Autonoma Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, Argentina
La Rioja, Argentina
Salta, Argentina
San Miguel de Tucumán, Argentina
San Salvador de Jujuy, Argentina