Phase II Study of Pemigatinib and Durvalumab for Advanced Intrahepatic Cholangiocarcinoma with FGFR-2 Fusion or Rearrangement

Sponsor: Mehmet Akce

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06728410

Provider View

This clinical trial is testing a combination of two drugs, pemigatinib and durvalumab, to see if they can help treat patients with a specific type of liver cancer that has a genetic change called FGFR-2 fusion or rearrangement. The study aims to find out if this treatment can control the cancer in patients who have already received other treatments.

Patient Parameters

Program Overview

This study is for patients with advanced intrahepatic cholangiocarcinoma, a type of liver cancer, who have a genetic change known as FGFR-2 fusion or rearrangement. The trial will test a combination of two drugs: pemigatinib, taken orally, and durvalumab, given through an IV. Each treatment cycle lasts three weeks, with pemigatinib taken for two weeks followed by a one-week break, and durvalumab given once every three weeks. Patients will have regular check-ups and lab tests before each cycle, and their cancer will be assessed every nine weeks. Treatment will continue until the cancer progresses, side effects become too severe, or the patient or doctor decides to stop, with a maximum treatment period of 24 months.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a specific type of liver cancer with FGFR-2 fusion or rearrangement.
  • Must have previously received certain cancer treatments and either not responded, had side effects, or had stable disease for at least six months.
  • Must have measurable cancer that can be tracked.
  • Must have good organ function and meet specific blood test criteria.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Must be willing to follow the study protocol and attend all visits and tests.
  • Must have a life expectancy of at least 12 weeks.

Exclusion Criteria

  • Previous treatment with FGFR inhibitors.
  • Eye or vision problems that are significant.
  • Disorders affecting calcium or phosphate levels in the body.
  • Use of certain medications that affect liver enzymes within 14 days before starting the study.
  • Vitamin D deficiency requiring high doses of supplements.
  • Participation in another clinical trial within the last 3 months.
  • Recent cancer treatment within 28 days before starting the study.
  • Unresolved side effects from previous cancer treatments.
  • Active or untreated brain metastases.
  • Significant heart, lung, or other medical conditions that are not controlled.
  • Active infections like hepatitis or HIV.
  • Use of immunosuppressive medications within 14 days before starting the study.
  • Recent vaccination with live vaccines.
  • Pregnant or breastfeeding women, or those not using effective birth control.
  • Known allergies to study drugs.
  • Previous participation in a durvalumab study.
  • Severe side effects from previous immunotherapy treatments.

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