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
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
- Age range
- 18–130 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * Histologically/cytologically confirmed hea…
Interventions
- Drugvolrustomig
volrustomig
Locations (305)
- Research SiteBirmingham, Alabama
- Research SitePhoenix, Arizona
- Research SitePrescott Valley, Arizona
- Research SiteSpringdale, Arkansas
- Research SiteFountain Valley, California
- Research SiteLos Angeles, California