OncoMatch/Clinical Trials/NCT06728410
A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement
Is NCT06728410 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Pemigatinib and Durvalumab for intrahepatic cholangiocarcinoma.
Treatment: Pemigatinib · Durvalumab — This is a single arm phase II study of pemigatinib and durvalumab combination in patients with FGFR-2 fusion or rearrangement positive intrahepatic cholangiocarcinoma. Each cycle will be 3 weeks. Pemigatinib is administered at 13.5 mg orally daily 2 weeks on and 1 week off. Durvalumab is administered at 1500 mg intravenously once every 3 weeks. Subjects will require a visit with appropriate laboratory work prior to the start of each cycle. Disease assessment will occur every 9 weeks. Subjects will continue treatment until progression per RECIST 1.1, toxicity or subject/physician decision. A maximum of 24 months (about 35 cycles) of pemigatinib and durvalumab treatment from Cycle 1 Day 1 is allowed.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Cholangiocarcinoma
Biomarker criteria
Required: FGFR2 fusion
Required: FGFR2 rearrangement
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: gemcitabine cisplatin (gemcitabine, cisplatin) — unresectable locally advanced or metastatic cholangiocarcinoma
Have received gemcitabine cisplatin and durvalumab or another anti-PD-1 Ab for unresectable locally advanced or metastatic cholangiocarcinoma with either disease progression, intolerance to cytotoxic chemotherapy, or have received at least 6 months of therapy with stable disease or partial response.
Must have received: anti-PD-1 therapy (durvalumab) — unresectable locally advanced or metastatic cholangiocarcinoma
Have received gemcitabine cisplatin and durvalumab or another anti-PD-1 Ab for unresectable locally advanced or metastatic cholangiocarcinoma with either disease progression, intolerance to cytotoxic chemotherapy, or have received at least 6 months of therapy with stable disease or partial response.
Cannot have received: FGFR inhibitor
Prior therapy with a FGFR inhibitor
Lab requirements
Blood counts
ANC ≥1500/µL; Hgb ≥ 9 g/dL (no erythropoietin dependency or pRBC transfusion within last 2 weeks); Platelet ≥ 100,000/µL
Kidney function
Calculated creatinine clearance >40 mL/min
Liver function
Bilirubin ≤ 1.5 × ULN (except Gilbert's syndrome); AST/ALT ≤ 2.5 × ULN (≤ 5x ULN with liver metastases)
Cardiac function
Mean QTcF <470 ms (from 3 ECGs within 15 minutes at 5 minutes apart)
Demonstrate adequate organ function as defined below ... Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart) [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06728410 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 is a required biomarker for enrollment.
Does this trial require FGFR2?
Yes, FGFR2 rearrangement 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