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NCT07780838 · ClinicalTrials.gov record · last posted 2026-08-24

Cyclical Gemcitabine, Cisplatin, and Durvalumab Alternating With Pemigatinib for the Treatment of Unresectable, Locally Advanced or Metastatic Biliary Tract Cancers With FGFR2 Alterations

StatusNot Yet Recruiting
PhasePhase 2
Started2026-11-01
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from the ClinicalTrials.gov record
This phase II trial tests how well giving gemcitabine, cisplatin and durvalumab alternating with pemigatinib for the treatment of biliary tract cancer with FGFR2 alterations that cannot be removed by surgery (unresectable), that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pemigatinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein that signals cancer cells to multiply. This may help keep cancer cells from growing and may kill them. Giving gemcitabine, cisplatin and durvalumab alternating with pemigatinib may work well for the treatment of unresectable, locally advanced or metastatic biliary tract cancer with FGFR2 alterations.
Trial Details
NCT Number NCT07780838
Lead Sponsor Ohio State University Comprehensive Cancer Center
Collaborators: Incyte Corporation
Conditions Locally Advanced Ampulla of Vater Carcinoma, Locally Advanced Biliary Tract Carcinoma, Locally Advanced Extrahepatic Cholangiocarcinoma, Locally Advanced Gallbladder Carcinoma, Locally Advanced Intrahepatic Cholangiocarcinoma, Metastatic Ampulla of Vater Carcinoma, Metastatic Biliary Tract Carcinoma, Metastatic Extrahepatic Cholangiocarcinoma +15 more
Enrollment 29 participants
Start Date 2026-11-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-24