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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT07780838
Phase
PHASE2
Status
Not Yet Recruiting

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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Cisplatin — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Durvalumab — BIOLOGICAL
    Given IV
  • Gemcitabine — DRUG
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Pemigatinib — DRUG
    Given PO
  • Survey Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

First listed
Aug 24, 2026
Start date
Nov 1, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (chemoimmunotherapy, FGFRi cycles)
    See Detailed Description

Primary Outcome Measure

Overall survival (OS) [ Time Frame: At 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Sameek Roychowdhury, MD, PhD
[email protected]
614-685-5842
Sameek Roychowdhury, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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