ActiveCancerNIHR-supported projectDigestion, Kidneys & Other Organs
A phase 3 open-label, randomized, controlled study to evaluate the efficacy and safety of petosemtamab compared with investigator’s choice monotherapy treatment in previously treated patients with incurable, metastatic/recurrent head and neck squamous cell carcinoma
Recipient organisationNIHR Cambridge Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodFeb 2025 — Jun 2027
In plain English
AI plain-English summary
A new antibody drug, petosemtamab, is being tested against standard chemotherapy in patients with advanced head and neck cancer that has stopped responding to immunotherapy and chemotherapy. This matters because head and neck squamous cell carcinoma that has spread or recurred is incurable, and treatment options after first-line therapy fail are limited. Current standard-of-care drugs—cetuximab, docetaxel, or methotrexate—offer modest benefit with significant side effects. Petosemtamab targets two proteins, EGFR and LGR5, on cancer cells to help the immune system attack the tumour, potentially offering a more effective alternative. If the trial shows petosemtamab improves survival or tumour shrinkage compared to standard care, it could become a new treatment option for patients with few remaining choices. The study is a phase 3 open-label randomised controlled trial enrolling adults aged 18 and over. Participants receive either petosemtamab intravenously every two weeks or a standard drug weekly, continuing until the cancer progresses or side effects become intolerable. Follow-up lasts at least 18 months, with total participation around two years. Common side effects of petosemtamab include infusion reactions, rash, diarrhoea, and electrolyte imbalances.
View original technical description
Trial Population and RationaleThis is a study of the investigational medicine petosemtamab in participants, aged 18 and over, with advanced head and neck cancer who have failed immunotherapy and one line of chemotherapy. Petosemtamab is an antibody treatment designed to interact with proteins called EGFR and LGR5. These interactions may help the immune system fight cancer.ObjectiveThe purpose of this study is to compare how well petosemtamab works and how safe it is compared to standard of care (SoC) treatment in advanced head and neck cancer.Trial designParticipants will be assigned randomly to receive either petosemtamab or the SoC treatment (cetuximab, docetaxel, or methotrexate). This is an open-label study, which means that study teams, Sponsor, and participants will know the study treatment received. Participants will receive petosemtamab or SoC treatment until the cancer worsens, they have any intolerable side effects, or they withdraw. Then, participants will be followed for at least 18 months for long term effects. Total participation in the study will last about 2 years.InterventionsParticipants will receive treatments by intravenous (IV) infusion (slow injection), once every 2 weeks for participants assigned to petosemtamab, and once weekly for participants assigned to the SoC treatment. Risks/BenefitsPetosemtamab is designed to help the immune system to kill cancer cells and reduce tumour size.Participants may benefit from the study treatment but there is no guarantee. Although there may not be direct benefits to study participants, information from the study may benefit others in the future. The main side effects that occurred in participants receiving petosemtamab were infusion related reactions (symptoms can include fever, chills, shaking, low blood pressure, shortness of breath, headache, skin rash, abdominal pain, nausea and/or vomiting), rash, diarrhoea, and electrolyte imbalance.
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