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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506294-36-00

Acronym

D798EC00001

Enrollment

359

Registered

2024-04-17

Start date

2024-10-01

Completion date

Unknown

Last updated

2025-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresected Locally advanced Head and Neck Squamous Cell Carcinoma

Brief summary

Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors

Detailed description

Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population, Landmark Progression-Free Survival (PFS) Rates, Overall Survival (OS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors, Landmark Overall Survival (OS) Rates, Overall Survival (OS) in the unresected LA-HNSCC ITT population, Progression Free Survival 2 (PFS2), Concentration of volrustomig in serum and pharmacokinetic (PK) parameters, Presence of Anti-Drug-Antibodies (ADAs) against volrustomig in serum, Participant-reported physical functioning, Participant-reported global health status (GHS)/quality of life (QoL), Percentage of participants with Adverse Events

Interventions

DRUGvolrustomig

DRUGMYCOPHENOLATE MOFETIL

DRUGINFLIXIMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors	—

Secondary

Measure	Time frame
Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population, Landmark Progression-Free Survival (PFS) Rates, Overall Survival (OS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors, Landmark Overall Survival (OS) Rates, Overall Survival (OS) in the unresected LA-HNSCC ITT population, Progression Free Survival 2 (PFS2), Concentration of volrustomig in serum and pharmacokinetic (PK) parameters, Presence of Anti-Drug-Antibodies (ADAs) against volrustomig in serum, Participant-reported physical functioning, Participant-reported global health status (GHS)/quality of life (QoL), Percentage of participants with Adverse Events	—

Measure

Time frame

—

Countries

Austria, Belgium, France, Germany, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026