Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation

NCT06501625 · clinicaltrials.gov ↗

PHASE1,PHASE2

Phase

RECRUITING

Status

52

Enrollment

OTHER

Sponsor class

Conditions

Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation

Interventions

DRUG: Ivosidenib
DRUG: Durvalumab (for the first 8, 21-day, cycles)
DRUG: Gemcitabine (for the first 8, 21-day, cycles)
DRUG: Cisplatin (for the first 8, 21-day, cycles)
DRUG: Durvalumab (starting from cycle 9)
DRUG: Ivosidenib Recommended Combination Dose (RCD)

Sponsor

Institut de Recherches Internationales Servier