75
Participants
Start Date
June 30, 2025
Primary Completion Date
June 30, 2028
Study Completion Date
June 30, 2029
MP0317 + Gemcitabine + Cisplatine + Durvalumab
"* MP0317: 3 mg/kg IV(intraveinous), day 1, every 3 weeks for a maximum of 5 administrations~* Immuno-chemotherapy (ICT): cycle 1-5~ * Durvalumab 1500 mg IV, day 8 every 3 weeks~ * Gemcitabine 1000 mg/m² IV, days 8 and 15 every 3 weeks~ * Cisplatin 25 mg/m² IV, days 8 and 15 every 3 weeks~* Immuno-chemotherapy (ICT): cycle 6-8~ * Durvalumab 1500 mg IV every 3 weeks~ * Gemcitabine 1000 mg/m² at day 1, 8 every 21 days~ * Cisplatin 25 mg/m² at day 1, 8 every 21 days~* Then durvalumab (1500 mg IV) will be administrated in monotherapy maintenance every 4 weeks until progression or unacceptable toxicity."
CT-Scan
at baseline, every 6 weeks (± 1 week) for the first 24 weeks and then every 8 weeks until progression, at end of treatment visit, At each follow-up visit : Only for patients who have not progressed during treatment phase
Gemcitabine + Cisplatin + Durvalumab
"* Immuno-chemotherapy (ICT) for 8 cycles :~ * Durvalumab 1500 mg IV, day 1 every 3 weeks~ * Gemcitabine 1000 mg/m² IV, days 1 and 8 every 3 weeks~ * Cisplatin 25 mg/m² IV, days 1 and 8 every 3 weeks~* Then durvalumab (1500 mg IV) will be administrated in monotherapy maintenance every 4 weeks until progression or unacceptable toxicity."
CHU de Besançon, Besançon
Centre georges-François Leclerc, Dijon
CHU de Grenoble, Grenoble
Centre Léon Bérard, Lyon
CHU de Montpellier, Montpellier
Hôpital Beaujon, Paris
Hôpital La Pitié-Salpétrière, Paris
Institut Curie, Paris
Centre Eugène Marquis, Rennes
CHU de Tours, Tours
Institut Gustave Roussy, Villejuif
Collaborators (1)
Molecular Partners AG
INDUSTRY
Centre Hospitalier Universitaire de Besancon
OTHER