OncoMatch/Clinical Trials/NCT07780838
Cyclical Gemcitabine, Cisplatin, and Durvalumab Alternating With Pemigatinib for the Treatment of Unresectable, Locally Advanced or Metastatic Biliary Tract Cancers With FGFR2 Alterations
Is NCT07780838 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Durvalumab and Cisplatin for locally advanced ampulla of vater carcinoma.
Treatment: Cisplatin · Durvalumab · Gemcitabine · Pemigatinib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Cancer type
Cholangiocarcinoma
Tumor Agnostic
Biomarker criteria
Required: FGFR2 fusion/rearrangement or other gain-of-function alteration
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
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: FGFR inhibitor
Patients who received prior FGFR-targeted therapy
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L (1500/mm3); Platelets ≥ 75 × 10^9/L; Hemoglobin ≥ 90 g/L (9 g/dL); PT, INR, and APTT ≤ 1.5 × ULN (except for patients on blood thinners)
Kidney function
Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula)
Liver function
Serum bilirubin ≤ 1.5 × ULN (≤ 5 × ULN if the tumor involves the liver), unless associated with patient's primary cancer and/or metastases and with PI approval; AST and ALT ≤ 3 × ULN (≤ 5 × ULN if with liver metastases), unless associated with patient's primary cancer and/or metastases and with PI approval; biliary drains and stents are acceptable
ANC ≥ 1.5 × 10^9/L (1500/mm3); Platelets ≥ 75 × 10^9/L; Hemoglobin ≥ 90 g/dL (9 g/dL); PT, INR, and APTT ≤ 1.5 × ULN; Serum bilirubin ≤ 1.5 × ULN (≤ 5 × ULN if the tumor involves the liver); AST and ALT ≤ 3 × ULN (≤ 5 × ULN if with liver metastases); Creatinine clearance ≥ 50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07780838 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior FGFR inhibitor disqualifies patients from enrollment.
Does this trial require FGFR2?
Yes, FGFR2 fusion/rearrangement or other gain-of-function alteration is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages