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A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement

StatusRecruiting
PhasePhase 2
Started2026-01-27
View on ClinicalTrials.gov ↗
This is a single arm phase II study of pemigatinib and durvalumab combination in patients with FGFR-2 fusion or rearrangement positive intrahepatic cholangiocarcinoma. Each cycle will be 3 weeks. Pemigatinib is administered at 13.5 mg orally daily 2 weeks on and 1 week off. Durvalumab is administered at 1500 mg intravenously once every 3 weeks. Subjects will require a visit with appropriate laboratory work prior to the start of each cycle. Disease assessment will occur every 9 weeks. Subjects will continue treatment until progression per RECIST 1.1, toxicity or subject/physician decision. A maximum of 24 months (about 35 cycles) of pemigatinib and durvalumab treatment from Cycle 1 Day 1 is allowed.

Amendment history 2 changes detected by DataLookout

2026-09-03
critical
Primary completion pushed: 2026-07 → 2027-07
2026-09-03
minor
Completion pushed: 2027-07 → 2028-07
Trial Details
NCT Number NCT06728410
Lead Sponsor Mehmet Akce
Collaborators: AstraZeneca, Incyte Corporation, University of Alabama at Birmingham
Conditions Intrahepatic Cholangiocarcinoma, FGFR2 Gene Rearrangement, FGFR2 Gene Mutation
Enrollment 38 participants
Start Date 2026-01-27
Primary Completion 2027-07 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-09-02