A Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combo with Pembrolizumab in HNSCC

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.

• IRAS ID

  1011448

• Contact name

  Regulatory Department Regulatory Department

• Contact email

  Regulatory@Bicara.com

• Sponsor organisation

  Bicara Therapeutics Inc.

• Clinicaltrials.gov Identifier

  NCT06788990

• Research summary

  The main purpose of this study is to find out if the study drug, ficerafusp alfa (BCA101), or placebo (a solution that does not contain the study drug), in combination with pembrolizumab can help patients who have recurrent or metastatic head and neck cancer. The study will investigate the safety of the study drug and the way the body absorbs, distributes and gets rid of this study drug; how the study drug acts on the body and whether it works on this type of cancer. This study drug is experimental meaning it has not been approved by health authorities, such the UK Medicines and Healthcare Products Regulatory Authority (MHRA) for the treatment of cancer. Treating this type of cancer with the study drug in combination with pembrolizumab may better target cancer cells and help to avoid the development of resistance.
  It is estimated that approximately 687 participants will take part in this study globally. The research study procedures include screening for eligibility and study treatment including evaluations and follow-up visits. The study consists of 2 phases, Phase 2 and Phase 3. Phase 2 will look at 2 different doses of the study drug in combination with pembrolizumab. This is being done to determine the best dose of the study drug. Phase 3 will look at the dose of study drug selected from Phase 2 in combination with pembrolizumab as compared to placebo with pembrolizumab. Whether participants are enrolled into Phase 2 or Phase 3 of the study will depend on how many people have taken part in the study already. Participants will be randomised (like flipping a coin) on to the treatment arms mentioned above for Phase 2 and Phase 3. This is a double-blind study meaning neither the participants nor the study doctor will know whether they are receiving the study drug or placebo.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  25/LO/0520

• Date of REC Opinion

  3 Sep 2025

• REC opinion

  Further Information Favourable Opinion