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Study of petosemtamab compared to standard therapy in previously treated patients with metastatic or recurrent head and neck cancer

Fast replyRegistered drugNo placebo
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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 head and neck squamous cell carcinoma that has spread to other parts of the body (metastatic) or has come back (recurrent) and cannot be cured. The study will test a new medication called petosemtamab and compare it to other standard treatments that may include methotrexate, docetaxel, or cetuximab.

The purpose of this research is to determine if petosemtamab is more effective than currently available treatments in helping patients with head and neck cancer live longer and to see how well tumors respond to the treatment. The study is designed for patients whose cancer has continued to grow despite previous treatment with platinum-containing therapy and immune therapy.

During the study, participants will be randomly assigned to receive either petosemtamab or one of the standard treatments. All medications will be given through an intravenous infusion. The treatment period will last up to 6 months, depending on how well the treatment works and how well it is tolerated. Throughout the study, patients will have regular check-ups to monitor their health and assess how their cancer responds to treatment.

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 assessment

    Your doctor will assess if you have head and neck cancer that has spread or come back after previous treatments.

    The cancer must be in one of these areas: oropharynx, oral cavity, hypopharynx, or larynx.

    You must have previously received platinum therapy and anti-PD-1 treatment.

    Your overall health status will be evaluated, including organ function and physical capability.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either petosemtamab or another treatment chosen by your doctor.

    The other treatment options may include methotrexate, docetaxel, or cetuximab.

    All medications will be given through an intravenous infusion (directly into your vein).

  3. Step 3

    Treatment period

    You will receive regular treatments according to your assigned medication schedule.

    Your doctor will monitor how your cancer responds to treatment using imaging scans.

    Regular health assessments will check for any side effects or complications.

    Treatment will continue as long as it is helping and side effects are manageable.

  4. Step 4

    Follow-up period

    After treatment ends, you will have regular check-ups to monitor your health.

    Doctors will track how long the treatment effects last.

    The study will continue until March 2028.

Who can join the trial?

12 criteria

  • Must be 18 years or older and able to provide informed consent
  • Must have confirmed head and neck squamous cell carcinoma (a type of cancer) that has spread or is locally advanced and cannot be cured with standard therapy
  • Cancer must be located in one of these areas: oropharynx (back of the throat), oral cavity (mouth), hypopharynx (lower throat), or larynx (voice box)
  • Must have previously received and progressed after treatment with anti-PD-1 therapy (a type of immunotherapy) and platinum-containing therapy (a type of chemotherapy)
  • Must have measurable disease that can be evaluated by imaging scans
  • Must have good physical function with an ECOG score of 0 or 1 (able to perform daily activities with minimal assistance)
  • Must have a life expectancy of at least 12 weeks
  • Must have adequate organ function as specified in the protocol
  • Must be willing to provide a new tumor biopsy or existing tumor tissue sample
  • For patients with oropharyngeal cancer, must have documentation of p16 status (a specific tumor marker test)
  • Cannot have had previous anti-EGFR therapies, except if cetuximab was used with radiation therapy more than 1 year ago
  • HIV-positive patients may participate if they have a CD4+ count of 300 or higher, undetectable viral load, and are receiving HIV treatment

Who cannot join the trial?

12 criteria

  • Prior history of squamous cell carcinoma (a type of skin cancer) in areas other than head and neck
  • Active brain or spinal cord metastases (cancer that has spread to these areas) that are untreated or unstable
  • Previous treatment with experimental medications within 28 days before starting this study
  • Known severe allergic reactions to biological treatments or drugs
  • Presence of active, clinically significant infections requiring systemic treatment
  • Major surgery within 28 days before starting the study treatment
  • Significant heart problems including uncontrolled high blood pressure, unstable heart disease, or heart failure
  • Active autoimmune disease requiring systemic treatment
  • Other active cancers requiring treatment (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
  • Pregnant or breastfeeding women
  • Known infection with HIV, Hepatitis B, or Hepatitis C
  • Any medical condition that, in the investigator's opinion, would make participation unsafe
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Investigated drugs

Petosemtamab is an investigational medication being studied for treating head and neck cancer that has spread or come back after previous treatments. It works by targeting specific proteins on cancer cells to help fight the disease. Investigator's choice monotherapy refers to a single medication chosen by the doctor from a set of approved treatment options. This allows the doctor to select the most appropriate standard treatment for each patient based on their individual case. Both treatments are being compared to see which one is more effective at helping patients with head and neck cancer who have already tried other treatments, including platinum chemotherapy and immunotherapy (anti-PD-1 therapy), but whose cancer has continued to grow or spread.

What is already known about the treatment

Petosemtamab - An investigational monotherapy medication being studied in phase 3 clinical trials for the treatment of metastatic and recurrent head and neck squamous cell carcinoma (HNSCC) in patients who have previously undergone anti-PD-1 and platinum-based therapies. This medication is being evaluated against investigator's choice of treatment to assess its impact on overall survival and tumor response rates. Petosemtamab represents a new therapeutic approach in oncology, specifically targeting advanced head and neck cancers that have proven resistant to previous treatment methods. The drug is administered as a monotherapy, meaning it is used as a single agent rather than in combination with other treatments.

Investigated diseases

  • Head and Neck Squamous Cell Carcinoma (HNSCC)

    A type of cancer that begins in the squamous cells that line the moist surfaces inside the head and neck regions. The disease typically develops in the mucous membranes of the mouth, nose, and throat. It can spread (metastasize) to other parts of the body through the lymph system or bloodstream. The cancer can recur after initial treatment, appearing in the same area or spreading to other parts of the body. The condition affects the cells' normal growth and division processes, causing them to multiply uncontrollably and form tumors.

  • Metastatic Cancer

    A condition where cancer cells spread from their original location to other parts of the body. The process occurs when cancer cells break away from the primary tumor and travel through blood vessels or lymph vessels to form new tumors in other organs or tissues. These new tumors, called metastases, are the same type of cancer as the primary tumor. The spread can affect multiple organs simultaneously and represents an advanced stage of cancer development.

  • Recurrent Cancer

    A form of cancer that returns after a period during which the cancer could not be detected. The cancer may come back to the same place as the original tumor or to another place in the body. The reappearance can happen months or years after the initial treatment. The returning cancer cells are the same type as the original cancer.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510322-32-00Protocol codeMCLA-158-CL02Estimated enrolment600 patientsSponsorGenmab A/S

sourced from the EU Clinical Trials Register and site verification

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