A global study of volrustomig (MEDI5752) for participants with unresected locally advanced head and neck squamous cell carcinoma following definitive concurrent chemoradiotherapy - eVOLVE-HNSCC

Study identifier:D798EC00001

ClinicalTrials.gov identifier:NCT06129864

EudraCT identifier:N/A

CTIS identifier:2023-506294-36

Recruiting

Official Title

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)

Medical condition

Locally advanced head and neck squamous cell carcinoma

Phase

Phase 3

Healthy volunteers

No

Study drug

volrustomig

Sex

All

Estimated Enrollment

1145

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 14 Dec 2023
Estimated Primary Completion Date: 19 Jan 2029
Estimated Study Completion Date: 17 Jun 2030

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria