ClinicaliQ Trial Snapshot
- A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma — Recruiting • Phase III • Oncology • NCT06064877.
- What is being tested: Ficlatuzumab (a hepatocyte growth factor inhibitor) combined with cetuximab versus placebo plus cetuximab in patients with recurrent or metastatic HPV-negative head and neck squamous cell carcinoma.
- Patient eligibility overview: Adults with recurrent or metastatic HPV-negative head and neck cancer who are candidates for cetuximab-based treatment, representing a patient population with limited therapeutic options and poor prognosis.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The purpose of this study is to compare the efficacy and safety of ficlatuzumab plus cetuximab compared to placebo plus cetuximab in participants with recurrent/metastatic (R/M) HPV-negative Head and Neck Cancer. The primary hypothesis is that ficlatuzumab combined with cetuximab is superior to cetuximab alone in terms of progression-free survival and/or overall survival.
Eligibility Snapshot
- : * Male or female and ≥ 18 years of age * Histologically and/or cytologically confirmed primary diagnosis of R/M HNSCC * Participants with oropharyngeal cancer will be required to have proof of p16 negative status submitted on the basis of a pathology report * At least 1 measurable lesion by contrast CT or MRI scan according to RECIST v.1.1. Such lesions must not have been previously irradiated; if the measurable lesion(s) has been irradiated, clear progression must be documented * Participants must have failed prior therapy with an anti-PD-1/PD-L1 ICI and with platinum-based chemotherapy administered in combination or sequentially, in either the locally advanced or R/M setting. Failure of prior treatment may be due to progression of disease or intolerance to treatment * Patient's tumor must be considered inoperable and incurable * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with a life expectancy of at least 12 weeks * For women of childbearing potential (WOCBP), documentation of negative serum pregnancy test within 30 days of randomization * For WOCBP and male participants whose sexual partners are of childbearing potential, agreement to use an effective method of contraception during the study and for at least…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.