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A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement

NCT06728410 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-05-08

No results posted yet for this study

Summary

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.

Conditions

  • Intrahepatic Cholangiocarcinoma
  • FGFR2 Gene Rearrangement
  • FGFR2 Gene Mutation

Interventions

DRUG

Pemigatinib

Pemigatinib 13.5 mg

DRUG

Durvalumab

Durvalumab 1500 mg IV

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Incyte Corporation

    collaborator INDUSTRY

  • University of Alabama at Birmingham

    collaborator OTHER

  • Mehmet Akce

    lead OTHER

Principal Investigators

  • Mehmet Akce, MD · Sponsor-Investigator

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-27
Primary Completion
2026-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06728410 on ClinicalTrials.gov