90TiP FRAIL-IMMUNE: A multicenter, prospective, single arm phase II of the combination of durvalumab with carboplatin and paclitaxel as first-line treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck not eligible to standard chemotherapy (GORTEC 2018-03)

AbstractBackgroundOne third of patients with (R/M SCCHN) are not eligible to receive the standard first-line chemotherapy EXTREME (cisplatin, fluorouracile and cetuximab). In this population, the weekly scheme of carboplatin-paclitaxel demonstrated clinical efficacy an overall survival (OS) of 4.9-12.8 months and a response rate of 20-52%. In a study conducted in our center, patients ineligible to EXTREME due to performance status (PS) 2 or other reasons (excluding PS2) reached a median OS of 3.6 months and 11.5 months, respectively.Trial DesignA prospective, multicenter, single-arm phase II trial to study the efficacy and safety of durvalumab (anti-PD-L1) combined with carboplatin-paclitaxel in patients with R/M SCCHN ineligible to cisplatin. A first cohort of patients (n  = 64) with PS0-1 will be accrued, then a cohort of patients with PS2 (n = 38) if results of the cohort PS0-1 are positive. Patients will receive four 28-day cycles (carboplatin AUC2 and paclitaxel 80mg/m², D1, D8, D15) with 4-weekly infusions of 1500mg durvalumab (pursued for a maximum of 12 months). An initial safety run-in step with predefined stopping rules is being conducted in the first 6 patients of the cohort PS0-1. The primary objective will be to determine the efficacy (12-month OS rate) of the combination. The treatment will be considered for further investigations, if at l east 38 successes and 10 successes are observed in cohorts PS0-1 and PS2, respectively. Secondary endpoints will al...
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research