FIERCE-HN

• Research type

  Research Study

• Full title

  A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 STUDY OF FICLATUZUMAB IN COMBINATION WITH CETUXIMAB IN PARTICIPANTS WITH RECURRENT OR METASTATIC (R/M) HPV-NEGATIVE HEAD AND NECK SQUAMOUS CELL CARCINOMA (FIERCE-HN)

• IRAS ID

  1008912

• Contact name

  Mark Hegarty

• Sponsor organisation

  AVEO Pharmaceuticals, Inc.

• Eudract number

  2023-505606-42

• Clinicaltrials.gov Identifier

  NCT06064877

• Research summary

  The main purpose of this study is to investigate the safety, effectiveness, and tolerability of ficlatuzumab at two different doses when given with the established dose of cetuximab. The study will also investigate the pharmacokinetics, pharmacodynamics, and immunogenicity of ficlatuzumab. Pharmacokinetics is how the body absorbs, distributes, and eventually gets rid of a medication. Pharmacodynamics is how a medication affects the body, which is measured using markers in blood or tumour tissue. Immunogenicity is how the body’s immune system (the body’s natural defence against disease) responds, for example, if it reacts to a medication in the same way it reacts to infections.
  This study will include about 410 participants across 120 study centres all over the world. and will be done in 2 parts.
  At first, there will be 3 study treatment groups, called Arm 1, Arm 2, and Arm 3.
  • Participants in Arm 1 will be given ficlatuzumab (10 mg/kg) and cetuximab. There will be at least 70 and up to 163 participants in Arm 1.
  • Participants in Arm 2 will be given ficlatuzumab (20 mg/kg) and cetuximab. There will be at least 70 and up to 163 participants in Arm 2.
  • Participants in Arm 3 will be given placebo and cetuximab. There will be 163 participants in Arm 3.
  After 70 participants in Arm 1 and 70 participants in Arm 2 have had their first on-study scan to check for any change in the spread of their cancer (restaging), the effectiveness of the two different ficlatuzumab groups (Arm 1 and Arm 2) will be compared.
  After this point, only 1 of the ficlatuzumab groups (Arm 1 or Arm 2) will have more participants added to it.
  The study includes: Screening period, Study Treatment period, Follow-up visits and Long-term Survival Follow-up period:

• REC name

  Wales REC 5

• REC reference

  23/WA/0353

• Date of REC Opinion

  7 Feb 2024

• REC opinion

  Further Information Favourable Opinion