A phase 3 study of the safety and efficacy of petosemtamab compared to investigator's choice
Research type
Research Study
Full title
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
IRAS ID
1009629
Contact name
Barbara Richard
Contact email
Sponsor organisation
Merus N.V.
Clinicaltrials.gov Identifier
Research summary
Trial Population and Rationale
This 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.Objective
The 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 design
Participants 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.Interventions
Participants 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/Benefits
Petosemtamab 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.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
24/EE/0242
Date of REC Opinion
17 Sep 2024
REC opinion
Further Information Favourable Opinion