Phase 3 Global Trial for Cholangiocarcinoma Testing a Single Agent is Well Underway

Updates from the Phase 3 clinical trial called FIGHT-302 were just released at the 2021 European Society for Medical Oncology World Congress on Gastrointestinal Cancer.

The trial is comparing two different treatments for cholangiocarcinoma (CCA) in unresectable or metastatic forms. The treatments are a combination therapy of gemcitabine with cisplatin and pemigatinib used as a single agent therapy. The former is the current standard of care for those with advanced stages of CCA who have a FGFR2 fusions or FGFR2 rearrangements. The median progression free survival for these patients is currently 8 months.

But researchers were optimistic about Pemigatinib as a single-agent therapy. It is an oral inhibitor of FGFR1, FGFR2, and FGFR3. The phase 2 results were very promising.

FIGHT-302 (NCT03656536)

This trial is randomizing patients into two groups, each for one of the treatment regimes. In the first group, patients will be given pemigatinib at 13.5mg once each day for 3 weeks. If the patients do not reach hyperphosphatemia, they will receive 18mg in the next 3 week cycle.

In the second group, patients will be given gemcitabine at 1000mg/m2 and cisplatin at 25mg/m2 by IV. They will be given the treatment only on the first day and the 8th day of a 3 week cycle. The cycles will last for up to 8 cycles. Treatment will stop if the disease progresses or if there are concerning levels of toxicity. For patients in the second group, crossover may be permitted if disease progression occurs.

Once patients stop the treatment, they will be followed to monitor status every 12 weeks.

Physical evaluations throughout the trials will include ophthalmic exams, slit-lamp exams, as well as fundoscopy. These will occur once every three cycles as well as at the end of the treatment, and at any other point the researchers feel necessary.

The primary endpoint of this trial is progression free survival. Secondary endpoints are overall response rate, duration of response, and disease control rate. Finally, exploratory end points will include FGFR2 alterations within survival.

Screening Criteria

There are important eligibility requirements for this trial. First and foremost, participants must have a confirmed CCA diagnosis. Further, they must have:

  • No previous treatment of their advanced CCA
  • FGFR2 fusions or FGFR2 rearrangement
  • ECOG performance status between 0 and 1
  • No previous systemic therapy (this does not include nonadjuvant or adjuvant over 6 months prior to the start of the trial)
  • No retinal or corneal disorder
  • No history of any uncontrolled seizures
  • No mestastases in the central nervous system

Participants will be divided by region.

  1. Western ( EU and North America)
  2. Asia Specific
  3. All other areas

They will also be stratified by locally advanced tumor burden.

Other factors that will be documented when patients are screened include-

  • Prior/concomitant medications
  • Physical evaluations
  • Tumor imaging
  • Adverse events
  • Optical examinations
  • ECG
  • Serum hematology
  • ECOG performance status

Additionally, in the first cycle, quality of life will be assessed as will pharmacokinetics. Then, in the second cycle, all previous analyses will be reassessed. Finally, during follow-up, safety evaluations, status of disease, and survival will be documented.

You can read more about this trial and what its success could mean for patients here.

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