Phase II Study of Oral Pemigatinib and Intravenous Durvalumab for Advanced Intrahepatic Cholangiocarcinoma with FGFR-2 Fusion or Rearrangement after Prior Treatment

What this Trial Is About

Researchers are evaluating the combination of pemigatinib and durvalumab in adults with advanced intrahepatic cholangiocarcinoma who have FGFR-2 fusion or rearrangement. This single-arm phase II study focuses on patients previously treated for this condition to understand how this combination therapy affects tumor response over time. Participants will receive pemigatinib orally at 13.5 mg daily for two weeks followed by one week off in each 21-day cycle. Durvalumab is given intravenously at 1500 mg every three weeks on the first day of each cycle. Treatment continues until disease progression, unacceptable side effects, or a decision by the patient or physician, for up to 24 months or about 35 cycles. Before each cycle, participants will have lab tests and clinical visits to monitor health and treatment effects. Disease response will be assessed every 9 weeks using imaging and criteria known as RECIST 1.1. Researchers will track tumor response, survival, disease control, duration of response, and side effects throughout the study period.

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