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Study of ficerafusp alfa and pembrolizumab as first treatment for patients with PD-L1-positive recurrent or metastatic head and neck cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating recurrent or metastatic head and neck squamous cell carcinoma, a type of cancer that has either come back after initial treatment or spread to other parts of the body. The research evaluates a combination treatment using two medications: ficerafusp alfa (also known as BCA101) and pembrolizumab (KEYTRUDA). These medications are given through intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to determine if adding ficerafusp alfa to pembrolizumab works better than pembrolizumab with placebo for patients who have not received previous treatment for their advanced cancer. The study will test two different doses of ficerafusp alfa (750 mg and 1500 mg) to find the most effective and safest dose when combined with pembrolizumab.

During the treatment, participants will receive regular doses of the study medications for up to 24 months. The study will track how well the treatment works by measuring if the cancer shrinks or disappears (tumor response), how long patients live (overall survival), and how long patients live without their cancer getting worse (progression-free survival). The study will also monitor any side effects that participants may experience during treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment assignment

    After joining the study, you will be randomly assigned to one of three treatment groups:

    - Group A: ficerafusp alfa 1500 mg with pembrolizumab

    - Group B: ficerafusp alfa 750 mg with pembrolizumab

    - Group C: placebo with pembrolizumab

  2. Step 2

    Treatment administration

    You will receive medication through intravenous infusion (directly into your vein)

    The treatment will be given once weekly

    Both medications (ficerafusp alfa and pembrolizumab) will be administered as a solution for infusion

  3. Step 3

    Medical monitoring

    Your health will be regularly monitored through:

    - Blood tests to check organ function

    - Imaging scans to measure tumor response

    - Assessment of any side effects

    Your doctor will track if the cancer is responding to treatment using standardized measurement criteria (RECIST 1.1)

  4. Step 4

    Quality of life assessment

    You will complete questionnaires about:

    - Your overall health status

    - Quality of life

    - Pain levels related to head and neck cancer

  5. Step 5

    Study duration

    The study is expected to run from November 2025 to July 2029

    Your participation length will depend on how your cancer responds to treatment

    Treatment will continue until either your disease progresses or you experience unacceptable side effects

Who can join the trial?

11 criteria

  • Must be at least 18 years old when signing the consent form
  • Must have confirmed cancer that has spread or come back in specific areas of the head and neck (oral cavity, hypopharynx, larynx, or oropharynx)
  • Must have adequate organ function, including: - Sufficient blood cell counts - Good kidney function - Proper liver function - Normal blood clotting
  • Must not have received any previous treatment for cancer that has spread, or must have completed previous treatment at least 6 months ago
  • Must be willing to provide a tumor tissue sample or undergo a biopsy if needed
  • Must have a performance status of 0 or 1 (able to perform daily activities with minimal assistance)
  • Must sign an informed consent form and agree to follow study procedures
  • For women who can become pregnant: - Must have a negative pregnancy test - Must use effective birth control during the study
  • For men: - Must agree to use condoms during the study - Must not donate sperm during the study
  • Must have specific tumor characteristics that make them eligible for the study medication (pembrolizumab)
  • Must have measurable disease that can be evaluated by scans

Who cannot join the trial?

13 criteria

  • Prior treatment with any PD-1/PD-L1 inhibitor (a type of immunotherapy drug)
  • Active brain metastases (cancer that has spread to the brain) or spinal cord compression
  • History of autoimmune disease requiring systemic treatment in the past 2 years
  • Active or history of pneumonitis (inflammation of lung tissue)
  • Uncontrolled heart disease or high blood pressure
  • Active infection requiring systemic therapy
  • Known HIV, active hepatitis B, or active hepatitis C infection
  • History of other cancer within 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Pregnancy or breastfeeding
  • Current participation in other clinical trials
  • Major surgery within 4 weeks before starting the study treatment
  • Any condition that could interfere with study procedures or interpretation of results
  • Known allergies or sensitivity to study medications or their components
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Investigated drugs

  • Ficerafusp alfa

    is a new investigational medication being studied for treating head and neck cancer. It is designed to work together with another medication to help fight cancer cells. It is administered once weekly through an intravenous infusion.

  • Pembrolizumab

    is an immunotherapy medication that helps the body's immune system detect and fight cancer cells. It works by blocking a protein called PD-L1 that cancer cells use to hide from the immune system. It is given through an intravenous infusion.

What is already known about the treatment

  • Ficerafusp alfa (BCA101)

    An investigational biologic medication administered intravenously once weekly, currently being studied in clinical trials for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in combination with pembrolizumab. This drug is being evaluated at two dose levels (750mg and 1500mg) to determine the optimal biological dose for treatment effectiveness and safety. The medication is undergoing Phase 2/3 clinical trials to assess its efficacy when combined with pembrolizumab as a first-line treatment for PD-L1-positive cancer patients.

  • Pembrolizumab

    A well-established immunotherapy medication administered intravenously that belongs to the class of PD-1 inhibitors, which helps the immune system detect and fight cancer cells. This medication works by blocking the PD-1 pathway, which cancer cells often use to hide from immune system attacks, and is currently approved for treating various types of cancer, including head and neck squamous cell carcinoma. Pembrolizumab has demonstrated significant clinical benefits in treating multiple cancer types and serves as the backbone therapy in this clinical trial.

Investigated diseases

Head and Neck Squamous Cell Carcinoma - A type of cancer that begins in the squamous cells lining the moist surfaces inside the head and neck regions. It typically starts in the mouth, throat, or voice box and can spread to nearby tissues. The cancer forms when squamous cells develop genetic changes, causing them to grow uncontrollably and form tumors. When described as recurrent, it means the cancer has returned after treatment, while metastatic indicates the cancer has spread to other parts of the body beyond its original location.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-519654-37-00Protocol codeBCA101X301Estimated enrolment676 patientsSponsorBicara Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

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