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Phase 2 Study of Weekly Ficerafusp Alfa + Pembrolizumab vs Alternative Dosing in First‑Line Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

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What is this trial about?

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

A type of cancer called Head and Neck Squamous Cell Carcinoma that has returned or spread to other parts of the body is being studied. The treatment being tested combines two medicines given through a vein: an investigational drug known as ficerafusp alfa (also called BCA101) and an approved immunotherapy called pembrolizumab. Both medicines are delivered as an infusion, which means the drug is slowly mixed with fluid and placed into a vein over a short period.

The purpose of the study is to see if giving the investigational drug every three weeks works as well as giving it every week when used together with the immunotherapy. Participants will receive the weekly combination at first, then after a set time they will be randomly assigned to continue with the weekly schedule or switch to the three‑week schedule. The study is open‑label, meaning both the doctors and the participants know which schedule is being used.

During the trial, participants will come to the clinic for regular infusion visits, where the medicines are administered and basic health checks are performed. Blood tests and other routine exams will be done to watch for any side effects or changes in health. The treatment period lasts for several months, with follow‑up visits to monitor how the cancer responds and to ensure safety.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Assessments

    After joining the study, you will undergo initial medical examinations, including blood tests, imaging scans, and a review of your medical history to confirm eligibility for the trial.

  2. Step 2

    Randomization to Treatment Arm

    Based on the study design, you will be randomly assigned to one of two treatment groups: the weekly dosing group or the every‑3‑weeks dosing group.

  3. Step 3

    First Intravenous Infusion Session

    On the first treatment day you will receive an intravenous (IV) infusion of ficerafusp alfa at a dose of 2250 mg, followed by an IV infusion of pembrolizumab at a dose of 200 mg. Both medicines are administered through a needle placed in a vein.

    During the infusion you will be monitored for vital signs such as blood pressure, heart rate, and temperature.

  4. Step 4

    Weekly Dosing Schedule (Standard Arm)

    If you are assigned to the weekly arm, you will receive the 2250 mg dose of ficerafusp alfa by IV infusion once every week.

    On the same day, you will also receive the 200 mg dose of pembrolizumab by IV infusion.

    Treatment continues each week until disease progression, unacceptable side effects, or the end of the study period.

  5. Step 5

    Every‑3‑Weeks Dosing Schedule (Alternative Arm)

    If you are assigned to the alternative arm, you will receive the 2250 mg dose of ficerafusp alfa by IV infusion once every three weeks (on day 1 of each 3‑week cycle).

    On the same day, you will also receive the 200 mg dose of pembrolizumab by IV infusion.

    The three‑week cycle repeats until disease progression, unacceptable side effects, or the end of the study period.

  6. Step 6

    Regular Monitoring Visits

    At each infusion visit you will have blood drawn to check laboratory values and to assess the levels of the study drugs.

    You will also be asked about any new symptoms or side effects, which are recorded as treatment‑emergent adverse events.

  7. Step 7

    Imaging Assessments

    Imaging scans (such as CT or MRI) will be performed at scheduled intervals, typically every 6 to 8 weeks, to evaluate the size of the tumor.

    The scans are reviewed by an independent central review team using standard criteria (RECIST 1.1) to determine response.

  8. Step 8

    Maintenance Phase

    If you continue treatment after the initial cycles, you will enter a maintenance phase where the same dosing schedule (weekly or every‑3‑weeks) is maintained.

    The primary goal during this phase is to remain progression‑free and alive after randomization.

  9. Step 9

    End of Treatment and Follow‑Up

    Treatment stops when disease progression is confirmed, side effects become severe, or the study reaches its planned end date.

    After stopping treatment, you will have follow‑up visits every few months to monitor overall health and survival.

Who can join the trial?

15 criteria

  • Sign a written informed consent form and agree to follow all study procedures; only participants who can make their own decisions may join.
  • Be at least 18 years old (or meet the minimum age required by local rules).
  • Have a diagnosis of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) confirmed by tissue testing, with the primary tumor in the oral cavity, hypopharynx, larynx, or oropharynx (if in the oropharynx, the cancer must be HPV‑negative).
  • Not have received any cancer‑directed medicines (systemic therapy) for recurrent or metastatic disease; previous systemic treatment given more than 6 months ago for earlier disease is allowed.
  • Agree to give a sample of tumor tissue that was saved from earlier treatment, or allow a new biopsy (a small piece of tissue taken with a needle) if needed.
  • If the cancer started in the oropharynx, provide proof that it is HPV‑negative using a validated test.
  • Be eligible to receive the drug pembrolizumab as the first‑line single treatment, and have a tumor test showing PD‑L1 CPS score of 1 or higher (a measure of a protein that helps select therapy).
  • Have disease that can be measured on scans according to RECIST 1.1 criteria (standard rules for tracking tumor size).
  • Have an ECOG performance status of 0 or 1, meaning you are fully active or able to carry out light work.
  • Show adequate organ function, including:
    • Blood counts: enough white cells (ANC ≥1,500/µL), platelets (≥100,000/µL), and hemoglobin (≥9 g/dL) without a recent blood transfusion.
    • Kidney function: a creatinine clearance within normal limits as measured by the clinic.
    • Liver function: normal bilirubin (≤1.5 × upper limit) and liver enzymes (AST/ALT ≤2.5 × normal, or ≤5 × normal if liver metastases are present).
    • Blood clotting: normal INR/PT/PTT values (≤1.5 × normal) unless you are on blood thinners that are well‑controlled.
    • Women who could become pregnant must have a negative, highly sensitive blood pregnancy test within 7 days before the first dose and must use highly effective birth control, be surgically sterile, or agree to abstain for the study period.
    • Male participants must agree to use a condom or abstain from heterosexual intercourse and must not donate sperm from the first dose until a specified time after the last dose.

Who cannot join the trial?

24 criteria

  • You cannot have had any previous chemotherapy or other whole‑body (systemic) treatment for your recurrent or metastatic head and neck cancer.
  • If you have had a heart attack with ST‑elevation, severe or unstable chest pain (angina), dangerous heart rhythm problems, heart bypass surgery or a heart/stent placed, or a stroke within the past 6 months, you cannot join. Also, if you have very advanced heart failure (New York Heart Association Class III or IV), you are excluded. (Patients with a stable deep‑vein clot who have been on blood‑thinners for at least 3 months may be allowed.)
  • You must wait at least 2 weeks after any major surgery (including eye surgery) or palliative radiation before starting the study, and you must have fully recovered from any surgery or radiation.
  • If you have taken part in another clinical trial or received an experimental drug, you must wait at least 5 half‑lives of that drug or 4 weeks (whichever is shorter) before you can join.
  • If you have an active autoimmune disease that needed strong medicines such as disease‑modifying agents, corticosteroids, or other immune‑suppressing drugs in the past 2 years, you cannot participate. (Routine hormone replacements like insulin or thyroid hormone are not counted as systemic treatment.)
  • You cannot be enrolled if you had a serious bacterial, viral, or fungal infection within 4 weeks before the first dose, or if you have an ongoing infection that required hospitalization or intravenous antibiotics within 2 weeks.
  • Known mental health, behavioral, or substance‑abuse problems that would prevent you from following study rules exclude you.
  • If you have chronic hepatitis B that is active and you are not already on suppressive antiviral therapy, you cannot join. (If you are hepatitis B surface antigen positive, you may join only if you have been on antiviral treatment for at least 4 weeks and have an undetectable viral load.)
  • If you have hepatitis C that has not been cured, or if your hepatitis C viral load is still detectable at screening, you are excluded. (You must have completed curative antiviral therapy at least 4 weeks before enrollment.)
  • Having a known HIV infection (HIV‑1 or HIV‑2 antibodies) makes you ineligible, unless local rules require testing.
  • Anyone who has received an organ transplant, including stem‑cell transplants, is excluded unless the transplant does not require immune‑suppressing medication.
  • If you have been diagnosed or treated for any other cancer within the past 2 years, you cannot join, except for certain skin cancers, in‑situ cervical or breast cancer, or low‑risk early‑stage prostate cancer that meets specific criteria.
  • Using systemic steroids (more than 10 mg of prednisone‑equivalent per day) or other immune‑suppressing drugs within 7 days before the first dose will exclude you, unless the steroids are only topical, nasal, inhaled, or eye drops, or are given as a pre‑medication for allergy prevention.
  • Receiving a live or live‑attenuated vaccine within 4 weeks before screening will exclude you. (Killed or inactivated vaccines are allowed.)
  • Being pregnant or breastfeeding disqualifies you from the study.
  • A past or current history of non‑infectious lung inflammation (pneumonitis or interstitial lung disease) excludes you.
  • If you have ever had a severe skin reaction to a drug, such as Stevens‑Johnson syndrome, toxic epidermal necrolysis, drug‑reaction with eosinophilia and systemic symptoms (DRESS), or other serious immune‑mediated skin problems, you cannot participate.
  • Previous treatment with anti‑transforming growth factor‑beta (TGF‑β) therapy makes you ineligible.
  • Prior therapy with an anti‑EGFR antibody excludes you.
  • If you received an immune‑checkpoint inhibitor (a type of cancer immunotherapy) as neoadjuvant or adjuvant treatment within the last 6 months, you cannot join.
  • If it has been less than 6 months since you finished curative‑intent platinum‑based chemotherapy for locally advanced head and neck cancer, you are excluded.
  • If your doctor believes you have less than 3 months of expected life left or that your disease is progressing very quickly, you cannot be enrolled.
  • Active cancer spread to the brain or spinal cord, a history of spinal cord compression from tumor, cancer involving the protective membranes of the brain (carcinomatous meningitis) or leptomeningeal disease excludes you, unless treated brain lesions have been stable for at least 4 weeks and you have not needed steroids for at least 14 days.
  • Being at high risk for bleeding, having a known bleeding disorder, active major bleeding, or a major bleeding event within the past 4 weeks excludes you. (Major bleeding includes life‑threatening bleeding, bleeding in a critical organ, a drop in hemoglobin of 2 g/dL or more, or needing two or more units of blood.)
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Investigated drugs

  • Ficerafusp Alfa

    is an investigational medicine being tested for the first time in this study. It is given through an IV infusion, meaning it is delivered directly into a vein. In the trial, it is combined with another drug to see if giving it every week can keep the cancer under control in patients with head and neck cancer that has come back or spread. Researchers are looking at how well it works to shrink or stop tumor growth when used continuously each week.

  • Pembrolizumab

    (known by the brand name KEYTRUDA) is an already approved immunotherapy that helps the body’s immune system recognize and attack cancer cells. It is also given by IV infusion. In this study, it is used together with ficerafusp alfa as part of the standard treatment plan. The purpose is to see if the combination improves the anti‑cancer effect compared with a different dosing schedule of ficerafusp alfa.

What is already known about the treatment

  • Ficerafusp Alfa

    This drug is given as a powder that is mixed with liquid and infused into a vein once a week. It is still being studied in clinical trials and is not yet approved for general medical use. In this trial it is used for patients with recurrent or metastatic head and neck squamous cell carcinoma. It works by attaching to a protein on tumor cells and then alerting the immune system to attack the cancer, and it belongs to the class of targeted immunotherapy agents.

  • KEYTRUDA

    KEYTRUDA (pembrolizumab) is supplied as a ready‑to‑use liquid that is infused into a vein, usually every three weeks. It is an approved medication that is already used to treat several cancers, including head and neck squamous cell carcinoma. In this study it is combined with ficerafusp alfa for the same type of head and neck cancer. It blocks a “brake” called PD‑1 on immune cells, allowing them to better recognize and destroy cancer cells, and it is classified as a checkpoint inhibitor monoclonal antibody.

Investigated diseases

Recurrent or metastatic head and neck squamous cell carcinoma - It is a cancer that begins in the flat cells lining the mouth, throat, or voice box and has either returned after prior treatment or spread to other parts of the body. The tumor may grow at the original site or appear in distant organs such as the lungs or bones. As the disease progresses, new lesions can develop and existing ones can enlarge, leading to worsening symptoms. Monitoring focuses on whether the cancer continues to grow or remains stable.
Trial detailsLast updated 2 Nov 2026
Age18+ yearsPhasePhase IITrial ID2026-526741-10-00Protocol codeBCA101X201Estimated enrolment89 patientsSponsorBicara Therapeutics Inc.

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