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Study of INBRX-106 and Pembrolizumab for First-Line Treatment in Patients with 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 clinical trial is focused on studying a type of cancer called Head and Neck Squamous Cell Carcinoma (HNSCC), which can occur in areas such as the mouth, throat, and voice box. The study is looking at patients whose cancer has come back or spread to other parts of the body and who have a specific protein called PD-L1 present in their tumors. The trial will test the effectiveness of a new treatment combination using two medications: INBRX-106 and Pembrolizumab, also known by its brand name KEYTRUDA. Pembrolizumab is a type of medicine called a monoclonal antibody, which helps the immune system fight cancer. INBRX-106 is another type of antibody that targets a specific part of the immune system to help it work better against cancer.

The purpose of the study is to compare the effectiveness of the combination of INBRX-106 and Pembrolizumab against Pembrolizumab alone. Some patients will receive the combination treatment, while others will receive only Pembrolizumab. A third group will receive a placebo, which looks like the treatment but does not contain any active medicine. The study will help determine if adding INBRX-106 to Pembrolizumab provides better outcomes for patients with this type of cancer.

Participants in the study will receive their assigned treatment through an intravenous infusion, which means the medicine is given directly into a vein. The study will last for a period of up to 105 weeks, during which time patients will be monitored regularly to assess how well the treatment is working and to check for any side effects. The goal is to find out if the new combination treatment can improve the chances of controlling the cancer and extending the lives of patients with recurrent or metastatic HNSCC.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The study involves two main treatments: INBRX-106 and pembrolizumab. Pembrolizumab is administered as a 25 mg/mL concentrate for solution for infusion. INBRX-106 is given as a solution for injection.

    Both medications are administered intravenously, meaning they are given directly into a vein. The specific dosage and frequency will be determined by the study protocol and the healthcare team.

  2. Step 2

    Treatment administration

    The treatment is given in cycles. Each cycle's duration and the number of cycles will be specified by the healthcare team based on the study protocol.

    During each cycle, the patient will receive the assigned treatment, which may include either pembrolizumab alone or a combination of INBRX-106 and pembrolizumab.

  3. Step 3

    Monitoring and assessments

    Regular monitoring will occur to assess the patient's response to the treatment. This includes physical examinations, blood tests, and imaging studies as needed.

    The healthcare team will evaluate the effectiveness of the treatment and monitor for any side effects or adverse reactions.

  4. Step 4

    Follow-up and evaluation

    After completing the treatment cycles, follow-up visits will be scheduled to continue monitoring the patient's health and response to the treatment.

    The study aims to compare the effectiveness of the combination treatment versus pembrolizumab alone in terms of overall response rate, progression-free survival, and overall survival.

Who can join the trial?

22 criteria

  • Able to understand and provide written informed consent.
  • Life expectancy of more than 3 months.
  • **Adequate organ function** based on screening lab tests done within 3 days of starting the study. This includes:
    • **Hematological** (blood-related) function:
      • Enough **neutrophils** (a type of white blood cell) without needing a transfusion or growth factor support.
      • Enough **platelets** (cells that help with blood clotting).
      • Enough **hemoglobin** (a protein in red blood cells that carries oxygen).
      • **Renal** (kidney-related) function:
        • Normal **creatinine** levels (a waste product filtered by the kidneys) or a creatinine clearance rate that meets the study's standards.
        • **Hepatic** (liver-related) function:
          • Enough **albumin** (a protein made by the liver).
          • Normal levels of **AST** and **ALT** (enzymes that indicate liver health).
          • Normal **bilirubin** levels (a substance made during the breakdown of red blood cells).
          • **Coagulation** (blood clotting) function:
            • Normal **INR** or **PT** (tests that measure how well your blood clots), unless on blood thinners.
            • Normal **PTT** (another test for blood clotting), unless on blood thinners.
            • Female patients who can have children must have a negative pregnancy test within 72 hours before starting the study and must not be breastfeeding.
            • Male and female patients who can have children must agree to avoid heterosexual sex or use acceptable birth control methods during the study and for 120 days after the last dose.
            • Willingness and ability to follow the study visit schedule and comply with all study procedures, as judged by the study doctor.
            • Must be at least 18 years old at the time of signing informed consent.
            • Must have a confirmed diagnosis of **Head and Neck Squamous Cell Carcinoma** (HNSCC) that is recurrent or metastatic and cannot be cured by local treatments.
            • The primary tumor must be located in the oral cavity, oropharynx, hypopharynx, or larynx.
            • Consent to provide the most recent tumor tissue sample for testing.
            • Confirmed **PD-L1 CPS** of 20 or more, as tested on the most recent tumor tissue sample.
            • Confirmed **HPV tumor status** for oropharyngeal cancer, as tested on the most recent tumor tissue sample. Testing is not required for oral cavity, hypopharynx, and larynx cancer.
            • Must have measurable disease according to specific guidelines. Tumors previously treated with radiation or other local therapies are considered measurable only if disease progression is clearly documented after treatment.
            • **ECOG PS score** of 0-1, which is a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities.

Who cannot join the trial?

4 criteria

  • Patients with medical conditions other than Head and Neck Squamous Cell Carcinoma cannot participate. This is a type of cancer that affects certain areas of the head and neck.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection, like children or those unable to give consent.
  • Patients who do not meet other specific health criteria set by the study cannot participate. These criteria are usually related to the patient's overall health and medical history.
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Investigated drugs

  • INBRX-106

    is an investigational medication being studied for its potential to help the immune system fight cancer. It is being tested in combination with another medication to see if it can improve treatment outcomes for patients with certain types of head and neck cancer.

  • Pembrolizumab

    is a medication that helps the immune system attack cancer cells. It is already used to treat various types of cancer, including head and neck cancer. In this study, it is being used alone and in combination with another investigational medication to see which approach is more effective.

What is already known about the treatment

  • INBRX-106

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating recurrent or metastatic head and neck squamous cell carcinoma. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication is for cancers expressing PD-L1. INBRX-106 works by targeting specific proteins on cancer cells, enhancing the immune system's ability to attack these cells. It is classified as an immunotherapy agent.

  • Pembrolizumab

    This medication is given through an intravenous infusion and is an established treatment in medicine, particularly for various types of cancer, including head and neck squamous cell carcinoma. It is approved for use in patients with tumors expressing PD-L1. Pembrolizumab functions by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and destroy cancer cells. It belongs to the class of drugs known as immune checkpoint inhibitors.

Investigated diseases

Head and Neck Squamous Cell Carcinoma – This is a type of cancer that originates in the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, nose, and throat. It typically begins as a small, localized growth or sore that does not heal. As the disease progresses, it can invade nearby tissues and spread to lymph nodes in the neck. Symptoms may include a persistent sore throat, difficulty swallowing, and changes in voice. Over time, the cancer can spread to other parts of the body, leading to more complex symptoms. Early detection is crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-515538-34-00Protocol codeINBRX106-01-201Estimated enrolment410 patientsSponsorInhibrx Biosciences Inc.

sourced from the EU Clinical Trials Register and site verification

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