Trials / Recruiting
RecruitingNCT06728410
A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement
A Phase II Study of Pemigatinib Plus Durvalumab (MEDI4736) in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- Sponsor
- Mehmet Akce · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pemigatinib | Pemigatinib 13.5 mg |
| DRUG | Durvalumab | Durvalumab 1500 mg IV |
Timeline
- Start date
- 2026-01-27
- Primary completion
- 2026-07-01
- Completion
- 2027-07-01
- First posted
- 2024-12-11
- Last updated
- 2026-04-08
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06728410. Inclusion in this directory is not an endorsement.