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

Summary

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.

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
• Metastatic Gallbladder Carcinoma
• Metastatic Intrahepatic Cholangiocarcinoma
• Stage III Ampulla of Vater Cancer AJCC v8
• Stage III Distal Bile Duct Cancer AJCC v8
• Stage III Gallbladder Cancer AJCC v8
• Stage III Intrahepatic Cholangiocarcinoma AJCC v8
• Stage IV Ampulla of Vater Cancer AJCC v8
• Stage IV Distal Bile Duct Cancer AJCC v8
• Stage IV Gallbladder Cancer AJCC v8
• Stage IV Intrahepatic Cholangiocarcinoma AJCC v8
• Unresectable Ampulla of Vater Carcinoma
• Unresectable Biliary Tract Carcinoma
• Unresectable Extrahepatic Cholangiocarcinoma
• Unresectable Gallbladder Carcinoma
• Unresectable Intrahepatic Cholangiocarcinoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

BIOLOGICAL

Durvalumab

Given IV

DRUG

Gemcitabine

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Pemigatinib

Given PO

OTHER

Survey Administration

Ancillary studies

Sponsors & Collaborators

• Incyte Corporation

  collaborator INDUSTRY

• Ohio State University Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Sameek Roychowdhury, MD, PhD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-11-01

Primary Completion

2027-12-31

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States

Study Locations