Ohio State University Comprehensive Cancer Center
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.
PRIMARY OBJECTIVE: I. To evaluate the efficacy of cyclical therapy alternating with chemoimmunotherapy and pemigatinib in patients with advanced cholangiocarcinoma and FGFR2 fusions and rearrangements, or other gain-of function alterations involved in FGFR. SECONDARY OBJECTIVES: I. To further evaluate the tumor response and other clinical benefits of cyclical therapy alternating with chemoimmunotherapy and pemigatinib. II. To characterize the safety and tolerability of cyclical therapy alternating with chemoimmunotherapy and pemigatinib. EXPLORATORY OBJECTIVES: I. To evaluate liquid biop…
Inclusion Criteria: * Adults 18 years of age or older with histologically or cytologically confirmed unresectable locally advanced or metastatic carcinoma of the biliary tract, including intrahepatic and extrahepatic cholangiocarcinoma, gallbladder, and ampulla of Vater, at the time of diagnosis * Patients must have tumors classified as having FGFR2 gene fusion/rearrangements or other gain-of function alterations involved in FGFR as detected by any analytically validated, Clinical Laboratory Improvement Act (CLIA)-certified molecular testing, including commercial tests (Foundation Medicine, C…
Undergo blood sample collection
Given IV
Undergo CT scan
Given IV
Given IV
Undergo MRI
Given PO
Ancillary studies