About this trial
This is an open-label, randomized, prospective, multicenter phase III trial to evaluate the efficacy and safety of the combination therapy of cetuximab with either pembrolizumab or finotonlimab, alongside chemotherapy, as a first-line treatment, compared with pembrolizumab or finotonlimab with chemotherapy for R/M HNSCC.
Eligibility criteria
Qualifiers
Age 18-70 years;
ECOG Performance Status 0 or 1;
Histologically confirmed diagnosis of head and neck squamous cell carcinoma;
Subjects with distant metastasis or local recurrence not suitable for curative treatment; local recurrence patients must have previously received radiotherapy (postoperative or radical);
Disqualifiers
Nasopharyngeal carcinoma;
Known allergic reaction against any of the components of the trial treatment;
a. Previous treatment with immune checkpoint inhibitors (ICIs) (Prior receipt of ICIs is allowed if they were given as part of curative-intent neoadjuvant therapy, with more than 6 months between the last dose and disease recurrence, or as adjuvant ICI monotherapy that achieved disease control for over 6 months); b. Previous treatment with cetuximab (Prior receipt of cetuximab is allowed if they were given as part of curative-intent therapy, with more than 6 months between the last dose and disease recurrence); c.Previous treatment with chemotherapy (Prior receipt of chemotherapy is allowed if they were given as part of curative-intent neoadjuvant and adjuvant therapy, with more than 6 months between the last dose and disease recurrence) The end date of the therapies mentioned above is the date of the last administration.
Clinically significant heart disease, including severe heart failure: NYHA heart failure class III~IV, ischemic heart disease (e.g., myocardial infarction or angina), acute myocardial infarction or congestive heart failure or QTc interval greater than 500 ms within the last 6 months;
Trial design
Treatments tested in this trial
- cetuximab+PD-1 mAb(Pembrolizumab/Finotonlimab)+chemotherapy
- PD-1 mAb (Pembrolizumab/Finotonlimab) + chemothearpy
Treatment groups
Sponsors and collaborators
Ji Dongmei
Lead sponsor
Fudan University
Sponsor institution