LIGUFALIMAB

LIGUFALIMAB is being studied in clinical trials for people with recurrent and/or metastatic squamous cell carcinoma of the head and neck. These trials look at whether it can help improve survival, especially in first-line treatment, and compare it with standard treatment. The main focus is on safety and how well the treatment works in the study population.

Table of contents

Trial overview

One authorised Phase 3 trial is studying LIGUFALIMAB in people with recurrent and/or metastatic squamous cell carcinoma of the head and neck.[1] This is an interventional study, which means the researchers give study treatment and then measure the results.[1]

Study design and treatment groups

The trial compares ivonescimab plus LIGUFALIMAB with pembrolizumab, and also compares ivonescimab alone with pembrolizumab.[1] The study summary says this is for first-line treatment, meaning the first treatment given for this cancer.[1]

The trial includes a treatment group with LIGUFALIMAB given as an intravenous infusion, which means it is given through a vein.[1] The source also lists pembrolizumab and ivonescimab as the other study treatments.[1]

Who can participate

The study is aimed at patients with recurrent and/or metastatic head and neck squamous cell carcinoma.[1] The brief summary also says the population is PD-L1 positive with CPS 1 or higher.[1] PD-L1 positive means the tumor has a marker that can help guide treatment choice, and CPS is a score used to measure that marker.[1]

What is being measured

The main outcome is overall survival.[1] Overall survival means how long patients live after starting treatment, and it is a key way to see whether a cancer treatment helps people live longer.[1]

Trial status and size

The trial status is Authorised.[1] The planned enrollment is 700 participants, showing that this is a large study.[1]

Trial ID Phase Condition studied Status Enrollment
2025-522996-27-00 Phase 3 Recurrent and/or metastatic squamous cell carcinoma of the head and neck Authorised 700

Ongoing Clinical Trials on LIGUFALIMAB

  • Study of ivonescimab alone or with ligufalimab versus pembrolizumab for patients with recurrent or metastatic head and neck squamous cell cancer

    Recruiting

    3 1 1 1
    Belgium France Spain

Glossary

  • Recurrent cancer: Cancer that has come back after treatment.
  • Metastatic cancer: Cancer that has spread to other parts of the body.
  • Squamous cell carcinoma: A cancer that starts in flat cells that line many parts of the body, including the head and neck area.
  • Head and neck cancer: Cancer that begins in the mouth, throat, voice box, nose, or nearby areas.
  • First-line treatment: The first treatment given for a disease.
  • PD-L1 positive: A test result showing that a tumor has PD-L1, a marker used to help choose some cancer treatments.
  • CPS: Combined Positive Score. This is a way to measure PD-L1 in the tumor and nearby immune cells.
  • Phase 3 trial: A later-stage study that compares treatments in a larger group of patients.
  • Interventional study: A study where patients receive a treatment being tested.
  • Overall survival: The length of time patients live after treatment starts.

References

  1. https://clinicaltrials.gov/study/2025-522996-27-00