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Brief Title: A Study of NG-641 and Pembrolizumab in Squamous Cell Carcinoma of the Head and Neck
Official Title: A Multicentre, Open-label, Dose-escalating, Phase Ib, Study of Intravenous Dosing of NG-641, as Monotherapy or in Combination With Pembrolizumab in Patients With Surgically Resectable Squamous Cell Carcinoma of the Head and Neck
Study ID: NCT04830592
Brief Summary: A multicentre, open-label, non-randomized, phase Ib neoadjuvant study of intravenous NG-641, as monotherapy or in combination with pembrolizumab, in patients with surgically resectable squamous cell carcinoma of the head and neck (SCCHN).
Detailed Description: Part A (NG-641 monotherapy): Approximately 16 evaluable patients will receive three doses of IV NG-641 in Part A. Patients will then proceed to planned surgical resection. Part B (NG-641 and pembrolizumab): Up to 20 evaluable patients will receive three doses of IV NG-641 and one dose of pembrolizumab. Patients will then proceed to planned surgical resection.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cardiff & Vale University LHB, Cardiff, , United Kingdom
The Clatterbridge Cancer Centre, Liverpool, , United Kingdom
The Royal Marsden Hospital, London, , United Kingdom
University Hospital Southampton NHS Foundation Trust, Southampton, , United Kingdom
Name: Christian Ottensmeier, Prof.
Affiliation: The Clatterbridge Cancer Centre
Role: PRINCIPAL_INVESTIGATOR