A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy
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)
AstraZeneca
1,145 participants
Dec 14, 2023
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria7
- 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.
- Participants with any of the following:
- 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.
Interventions
volrustomig
Locations(305)
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NCT06129864