The LiGeR-HN1 study is a phase 3 clinical research study for people who have head and neck squamous cell carcinoma (HNSCC), where the cancer has returned (recurrent) or spread to other parts of the body (metastatic).
The study will test an investigational agent, petosemtamab, to see if it works better against head and neck cancer when used with pembrolizumab, compared to using pembrolizumab only, which is an approved treatment for patients with this type of disease.
Study participants may be able to join the study if they meet the following requirements:
18 years of age or older
History of head and neck squamous cell carcinoma (HNSCC) with evidence of metastatic (spreading) or locally recurrent (returning) incurable disease
No previous therapy for recurrent incurable or metastatic HNSCC
Primary tumor locations in oropharynx (middle of throat), oral cavity (mouth), hypopharynx (bottom of throat), and larynx (voicebox)
*Other study requirements will apply. Ask your doctor if the study may be a good option for you.
Study participants can expect the following:
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Receive study health assessments to confirm if you qualify for the study. These tests include an ECHO/MUGA, ECG, blood and urine tests, CT/MRI, as well as a bone scan and a tumor biopsy if necessary.
The study doctor will review the test results and let you know if you are able to join the study.
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You will receive the study drug(s) based on your group assignment.
While receiving your assigned study drugs), complete regular study procedures (like those at Screening) every 2 weeks. The procedures will help the study doctor monitor your health and the effects of study drug(s).
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If you stop taking the study drug (s), the study team will ask you to complete more study procedures to monitor the effect of the study drugs (s). The study team will explain which procedures you will receive and the schedule.
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Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
The investigational agent being researched in the study is called petosemtamab, and it is given through IV infusion every 2 weeks.
Petosemtamab is a type of antibody designed to help fight cancer cells by targeting EGFR and LGR5 proteins. The purpose of the study is to test petosemtamab to see if it works better against advanced head and neck cancer when used in combination with pembrolizumab versus pembrolizumab alone.
To participate in this Study, your HNSCC needs to express a protein called programmed death-ligand 1 (PD-L1). PD-L1 is a protein on cancer cells that can stop the body's immune system from attacking and killing cancer cells.1
Pembrolizumab is an approved treatment that blocks the effects of PD-L1 and helps your immune system recognize and kill cancer cells. It is given through IV infusion every 6 weeks.
The combination of petosemtamab with pembrolizumab is being tested to determine whether it might lower the chance of cancer returning or spreading.
EGFR in our body plays a crucial role in cell growth1, and LGR5 is important for replacing damaged cells2. However, too much EFGR3 and LGR54 can drive HNSCC tumor growth.
Petosemtamab could potentially slow or stop the cancer growth and shrink HNSCC tumors.
2Modulation of stem cell fate in intestinal homeostasis, injury and repair - PubMed (nih.gov)
To learn if the combination of petosemtamab and pembrolizumab works better than pembrolizumab alone, everyone will receive pembrolizumab, an approved product for head and neck cancer, and half will also receive petosemtamab. You will be randomly assigned to one of these 2 groups, and treatment will last while you benefit from it:
*You have a 50 percent chance of being in either group. Neither you or your doctor can choose which treatment group you are assigned.
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), and it can only be used in clinical research studies like LiGeR-HN1.
Petosemtamab is an investigational agent and is not yet approved for marketing by any regulatory authority, nor demonstrated to be safe or effective for its intended use.
HNSCC, also known as head and neck cancer, is classified by its location: it can occur in the mouth (oral cavity), the middle part of the throat near the mouth (oropharynx), the space behind the nose (nasal cavity and paranasal sinuses), the upper part of the throat near the nasal cavity (nasopharynx), the voicebox (larynx), or the lower part of the throat near the larynx (hypopharynx). Depending on the location, the cancer can cause abnormal patches or open sores (ulcers) in the mouth and throat, unusual bleeding or pain in the mouth, sinus congestion that does not clear, sore throat, earache, pain when swallowing or difficulty swallowing, a hoarse voice, difficulty breathing, or enlarged lymph nodes.1
HNSCC can spread (metastasize) to other parts of the body, such as the lymph nodes or lungs.1
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or investigational agent is safe and effective for people. Before any investigational agent can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational drug, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical research study, contact a study clinic near you.
Use the filters, map, and listing to find the study clinic closest to you.