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 (May 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
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
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