A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)
A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)
The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).
Inclusion Criteria:
Exclusion Criteria:
Histologically/cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including participants with squamous cell carcinoma of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland). Participants with >1 primary tumors are not eligible for the study.
Participants with any of the following:
Participants who have received radiotherapy (RT) alone as definitive local therapy for LA-HNSCC.
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Hidaka-shi, 350-1298, Japan
Osakasayama-shi, 589-8511, Japan
Sagamihara-shi, 252-0375, Japan
Shinjuku-ku, 160-0023, Japan
Shiwa-gun, 028-3695, Japan
Sunto-gun, 411-8777, Japan
West San Juan City, 1502, Philippines
Chaing Mai, 50200, Thailand
Muang, 22000, Thailand
Mueang, 20000, Thailand
Hampshire, SO16 6YD, United Kingdom