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• W2890121225 abstract "6037 Background: Pembrolizumab (a humanized monoclonal antibody blocking programmed death receptor-1), and cetuximab (a chimeric monoclonal antibody inhibiting epidermal growth factor receptor) are both FDA-approved as single agents for second-line R/M HNSCC treatment. This is the first trial to combine pembrolizumab with cetuximab to evaluate anti-tumor synergy. As this specific drug combination has not been previously tested, an interim safety analysis was completed per protocol. Methods: Patients (pts) with R/M HNSCC were treated with pembrolizumab at a fixed dose of 200mg IV on day 1 with cetuximab 400mg/m2 loading dose followed by 250mg/m2 weekly (21-day cycle). The first 10 pts who enrolled and completed at least 1 cycle of therapy were included in the safety analysis. A mandatory study hold and Data Safety Monitoring Committee (DSMC) review were required if at least 4 of the 10 pts developed any grade (G) 3-4 non-hematologic toxicity. Results: Of the 10 patients included in the analysis, median age 58y (range 47-79y), M: F 5:5. 8 pts had mucosal (6 oral cavity, 1 oropharynx, 1 nasopharynx) and 2 had cutaneous HNSCC primaries. 65 adverse events (AEs) were reported in 9 pts; G1: 39, G2: 15, ≥G3: 11. Of the 11 ≥G3 AEs, only 1 was treatment-related (see Table). There were no treatment-related deaths or dose-limiting toxicities (DLTs). 3 pts discontinued treatment, none of which were due to toxicity (2 had disease progression, 1 withdrew from study). DSMC reviewed the safety data and permitted resumption of trial accrual. Of 7 evaluable pts, 4 partial responses were noted at first radiographic assessment. Clinical trial information: NCT03082534. Conclusions: Pembrolizumab combined with cetuximab has a very tolerable safety profile, with no DLTs. Efficacy analysis of this combination will be performed. Grade AE Frequency Description Related? Serious? 3 1 Acneiform rash Definite N 3 1 Hypotension Unlikely Y 3 1 Febrile neutropenia Unlikely Y 3 1 Fatigue Unlikely N 3 1 Dysphagia N Y 3 1 Aspiration N Y 3 1 Skin ulceration N Y 3 1 Lung infection N Y 4 1 Sepsis N Y 5 1 Death N Y 5 1 Death N Y" @default.
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• W2890121225 date "2018-05-20" @default.
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• W2890121225 title "An open-label, non-randomized, multi-arm, phase II trial evaluating pembrolizumab combined with cetuximab in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): Results of the interim safety analysis." @default.
• W2890121225 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.6037" @default.
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