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).
Histologically or cytologically documented locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of metastatic disease (i.e. M0).
Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of the American Joint Committee on Cancer (AJCC) staging manual (tumor, node, metastasis (TNM) staging system).
Participants will have completed definitive concurrent chemoradiotherapy (cCRT) with curative intent prior to randomization.
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.
LA-HNSCC that was resected before definitive cCRT
LA-HNSCC that was treated and is recurrent at the time of screening
Participants who have received radiotherapy (RT) alone as definitive local therapy for LA-HNSCC.
Parallel
volrustomig
Drugvolrustomig
Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors
PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause (in the absence of progression). The analysis will include all randomized participants with PD-L1 expressing tumors.
Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population
PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). The analysis will include all randomized participants.
Landmark Progression-Free Survival (PFS) Rates
PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). These analyses will include participants with PD-L1 expressing tumors and all randomized participants.
Overall Survival (OS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors
Overall survival (OS) is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants with PD-L1 expressing tumors.
Landmark Overall Survival (OS) Rates
OS is defined as the time from randomization until the date of death due to any cause. These analyses will include participants with PD-L1 expressing tumors as randomized and all randomized participants.
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