Status:
RECRUITING
A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy
Lead Sponsor:
AstraZeneca
Conditions:
Locally Advanced Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18-130 years
Phase:
PHASE3
Brief 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-HN...
Eligibility Criteria
Inclusion
- 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
- 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:
- 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.
Key Trial Info
Start Date :
December 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 12 2030
Estimated Enrollment :
1145 Patients enrolled
Trial Details
Trial ID
NCT06129864
Start Date
December 14 2023
End Date
September 12 2030
Last Update
November 26 2025
Active Locations (300)
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1
Research Site
Birmingham, Alabama, United States, 35233
2
Research Site
Phoenix, Arizona, United States, 85028
3
Research Site
Prescott Valley, Arizona, United States, 86314
4
Research Site
Springdale, Arkansas, United States, 72762