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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Mehmet Akce
Study ID
NCT06728410
Phase
PHASE2
Status
Recruiting
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Conditions

  • FGFR2 Gene Mutation
  • FGFR2 Gene Rearrangement
  • Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pemigatinib — DRUG
    Pemigatinib 13.5 mg
  • Durvalumab — DRUG
    Durvalumab 1500 mg IV

Study Details

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.

Key Dates

Start date
Jan 27, 2026
Status verified
May 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pemigatinib + Durvalumab
    Pemigatinib 13.5 mg will be taken orally at the same time each day for 14 days (Day 1 through Day 14), followed by 7 days off treatment (Day 15 through Day 21) of each 21 day cycle. Durvalumab 1500 mg IV will be administered every 3 weeks on Day 1 of each 21-day cycle.

Primary Outcome Measure

Confirmed objective response rate (ORR) [ Time Frame: 24 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Margaret (Meg) Thomas, MPH
[email protected]
(205) 895-1802
Mehmet Akce, MD (PRINCIPAL_INVESTIGATOR)
Roswell Park Cancer InstituteBuffaloNew York14263
Kayla Pham
[email protected]
1-800-767-9355
Kannan Thanikachalam, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Alabama at Birmingham· Birmingham, ALRoswell Park Cancer Institute· Buffalo, NY

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