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Brief Title: A Study Evaluating Efficacy and Safety of Multiple Treatment Combinations in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (Morpheus-Head and Neck Cancer)
Official Title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy and Safety of Multiple Treatment Combinations in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (Morpheus-Head and Neck Cancer)
Study ID: NCT05459129
Brief Summary: This is a Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with locally advanced squamous cell carcinoma of the head and neck (SCCHN). The study will enroll treatment-naive participants with resectable Stage III-IVA human papillomavirus (HPV)-negative, programmed death-ligand 1 (PD-L1)-positive SCCHN with measurable disease, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) who have not received systemic treatment for their disease.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, United States
UCLA Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
The George Washington Cancer Center, Washington, District of Columbia, United States
Winship Cancer Institute, Atlanta, Georgia, United States
N.C. Cancer Hospital, Chapel Hill, North Carolina, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Cancer Research SA, Adelaide, South Australia, Australia
Sir Charles Gairdner Hospital; Medical Oncology, Perth, Western Australia, Australia
Centre Francois Baclesse, Caen, , France
CHU Hopitaux de Bordeaux, CHU Hopitaux De Bordeaux, , France
Centre Léon Bérard, Lyon, , France
Institut de Cancérologie de Lorraine, Vandoeuvre-Les-Nancy, , France
Rambam Medical Center, Haifa, , Israel
Hadassah University Hospital - Ein Kerem; Oncology, Jerusalem, , Israel
Asan Medical Center, Seoul, , Korea, Republic of
Severance Hospital - Yonsei Cancer Center, Seoul, , Korea, Republic of
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR