Squamous Cell Carcinoma of Head and Neck Clinical Trial
Official title:
A Phase II Trial Assessing Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in a Pre-operative Setting for Resectable and Untreated Head and Neck Squamous Cell Carcinoma
This study is a prospective open label, multicenter, phase II, window-of-opportunity preoperative, single-agent trial. This study aims to evaluate the efficacy, the safety and tolerability profile of bintrafusp alfa in patients with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, previously untreated, with indication of primary surgery. Patients with a diagnosis of head and neck squamous cell carcinoma (HNSCC) from unknown primary will not be enrolled.
The study plans to enrol up to 59 patients in total. Eligible patients who have provided their written informed consent for study participation will be assigned to one the 2 cohorts described below: Cohort A (43 patients): Non-oropharyngeal HNSCC, or Oropharyngeal squamous cell carcinoma (SCC) that are human papillomavirus (HPV) negative, or Oropharyngeal SCC that are HPV positive and smoker ≥20 pack year (PY). A Minimax two-stage Simon design will be used with an unacceptable rate of pathological response of 30% or less and a hypothesized actual pathological response rate of 50% or more. In the first stage, 28 patients will be accrued. If the observed number of patients with a pathological response is 7 or less, then the study for the cohort A will conclude to inefficacy and patient recruitment in this cohort will be stopped. Cohort B (16 patients): Oropharyngeal SCC that are HPV positive and non-smoker or smoker <20 PY (former or active). The design for this cohort will be a single-stage design. All trial-related interventions will be strictly similar for these 2 cohorts. ;
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