The LiGeR-HN2 clinical research study is for people with advanced head and neck squamous cell carcinoma (HNSCC), where the cancer has returned (recurrent) or spread to other parts of the body (metastatic).
Treatment for advanced head and neck cancer that has progressed after being treated with immunotherapy and platinum-based chemotherapy often include drugs targeting EGFR such as cetuximab, or chemotherapy such as docetaxel or methotrexate. This study will compare the investigational agent petosemtamab to these commonly used therapies for advanced/metastatic head and neck cancer (cetuximab, methotrexate, or docetaxel).
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) disease
Previously treated with standard therapy including immunotherapy and platinum-based chemotherapy for metastatic or local recurrent 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.
Take the pre-screener now to see if you may qualify!
Take the Pre-ScreenerStudy participants can expect the following
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.
Take the pre-screener now to see if you may qualify!
Take the Pre-Screener
Petosemtamab is an investigational agent (not yet FDA approved) being developed for the treatment of head and neck cancer. It is an antibody, given by IV infusion every 2 weeks. Petosemtamab is designed to help fight cancer cells by targeting proteins that promote head and neck cancer growth, specifically EGFR and LGR5 proteins.
Study participants will be randomly assigned to receive either petosemtamab or one of three treatments commonly used for advanced or metastatic head and neck cancer: cetuximab1, methotrexate2, or docetaxel3. If you are assigned to receive one of the commonly used therapies, you and your study doctor will discuss which of these three options are best for you and your cancer.
Cetuximab, docetaxel, or methotrexate would be administered by IV infusion in accordance with standard of care for head and neck cancer treatment.
You will receive your assigned investigational agent for as long as you are benefiting from it. You will be closely monitored for side effects and response of your cancer whether you receive petosemtemab or one of the three permitted standard of care treatments. The study doctor may interrupt or stop your dosing if side effects occur.
To learn more about the approved treatments commonly used for advanced or metastatic head and neck cancer, please talk to your doctor or visit the following:
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 make cancer cells within HNSCC tumors grow.
Petosemtamab could slow the cancer growth.
2Modulation of stem cell fate in intestinal homeostasis, injury and repair - PubMed (nih.gov)
To learn how well petosemtamab works, study participants will be randomly assigned to a study group to receive either petosemtamab, or one of the approved medicines (cetuximab, methotrexate, or docetaxel). Half of the participants will receive petosemtamab, and the other half will receive one of the approved medicines.
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-HN2.
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 agent, 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.