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About
This is a Phase II treatment, non-randomized, open label clinical trial to study the efficacy of the Cetuximab when administered as single agent in recurrent/ metastatic head and neck squamous cell carcinoma after the failure or intolerance of immuno-oncology or immuno-oncology combined with chemotherapy.
Full description
Primary Objective:
• To measure Overall Response Rate to treatment with Cetuximab as single agent in patients with recurrent or metastatic head and neck squamous cell cancer who failed PD-1 inhibitors alone or in combination with chemotherapy.
Secondary Objective(s):
OUTLINE: Patients receive cetuximab intravenously (IV) over 60-120 minutes once every week in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 week and then every 6-8 weeks thereafter.
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
Any of the following conditions:
Pregnancy, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment.
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
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Study Nurse
Data sourced from clinicaltrials.gov
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