Unresectable CholangiocarcinomaPhase 2FIGHT-214NCT07862998
A Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma With FGFR2 Fusion or Rearrangements After at Least 1 Prior Line of Systemic Therapy
A Phase 2 study testing Pemigatinib in people with Unresectable Cholangiocarcinoma and Advanced/Metastatic Cholangiocarcinoma, run by Incyte Corporation.
Trial summary
The purpose of this study is to confirm the efficacy and safety of pemigatinib in participants with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 fusion or rearrangements after at least 1 prior line of systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Cholangiocarcinoma, Advanced/Metastatic Cholangiocarcinoma
- What is being tested?
- Pemigatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2026to 27 Mar 2031
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed unresectable, locally advanced or metastatic cholangiocarcinoma (CCA).
- Documented FGFR2 fusion or rearrangement
- Documented disease progression after at least 1 prior line of systemic chemotherapy, with or without immune checkpoint inhibitors (ICI).
- Life expectancy ≥ 12 weeks.
- An ECOG performance status of 0 to 1.
- Measurable disease by CT or MRI based on RECIST v1.1 as determined by site radiology.
- Willingness to avoid pregnancy or fathering children.
Who cannot join
- Prior treatment with any FGFR inhibitor for any indication.
- Liver cirrhosis, Child-Pugh B and C.
- Known CNS metastases or history of uncontrolled seizures, except participants with treated brain metastases and no evidence of progression for => 4 weeks and on stable or decreasing dose of corticosteroids for management of CNS metastases for =>1 week.
- Current evidence of clinically significant corneal or retinal as confirmed by ophthalmologic examination.
- History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.
- History of hypovitaminosis D requiring supraphysiologic doses (eg, 50,000 UI/week) to replenish the deficiency.
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- Clinically significant or uncontrolled cardiac disease or history or presence of an abnormal ECG, which, in the investigator's opinion, is clinically meaningful.
- Use of strong CYP3A4 inhibitors and inducers, moderate CYP3A4 inducers, and concomitant FGFR inhibitor, investigational drug and anticancer medication other than pemigatinib.
- Women who are pregnant or breastfeeding.
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma With FGFR2 Fusion or Rearrangements After at Least 1 Prior Line of Systemic Therapy (FIGHT-214)
The purpose of this study is to confirm the efficacy and safety of pemigatinib in participants with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 fusion or rearrangements after at least 1 prior line of systemic therapy.
- Being tested
- Pemigatinib
- Keywords
- Cholangiocarcinoma, FGFR inhibitor, FGFR, FGFR rearrangement
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemigatinibDrug
Also called Pemazyre
Pemigatinib at the protocol-defined dose administered orally once daily in 21-day cycles with 14 days on therapy followed by 7 days off therapy.
| Study group | Role | What they receive |
|---|---|---|
| Pemigatinib | Experimental | Not described Receives: Drug: Pemigatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response
Defined as having a confirmed best response of complete response (CR) or partial response (PR), as determined by an independent central review (ICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Up to approximately 18 months
Secondary outcomes (4)
Duration of Response (DoR)
Determined from earliest date of CR or PR until the earliest date of progressive disease (PD) as determined by an ICR per RECIST v1.1 or death due to any cause.
Measured: Up to approximately 18 months
Progression-free survival (PFS)
Determined from start of therapy until the earliest date of PD as determined by an ICR per RECIST v1.1 or death due to any cause.
Measured: Up to approximately 18 months
Overall Survival (OS)
Determined from the start of therapy until death due to any cause.
Measured: Up to approximately 18 months
Number of treatment-emergent adverse events
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug until up to 30 days after the last dose of study drug.
Measured: Up to approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start15 Dec 2026 (estimated)
- Primary completion25 Feb 2031 (estimated)
- Study completion27 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862998
- Sponsor's protocol ID
- INCB054828-214
- Other IDs
- 2025-523761-13-00, 2025
- Acronym
- FIGHT-214
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency