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A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy

Study acronym: eVOLVE-HNSCC
StatusRecruiting
PhasePhase 3
Started2023-12-14
View on ClinicalTrials.gov ↗

Amendment history

2026-09-02
Study Status, Contacts/Locations v16
Study sites306→305
2026-08-05
Study Status, Contacts/Locations v15
Study sitesdetails revised at 8 of 306 sites
2026-06-23
Study Status, Contacts/Locations v14
Primary completion pushed: 2028-04-18 → 2030-04-17
Completion pushed: 2030-09-12 → 2031-02-28
Study sites305→306
2026-05-12
Study Status, Contacts/Locations v13
Study sitesdetails revised at 15 of 305 sites
2026-03-13
Study Status, Contacts/Locations v12
Study sites304→305
Show 11 earlier versions
2026-02-02
Study Status, Contacts/Locations v11
Study sites300→304
2025-11-25
Study Status, Contacts/Locations v10
Study sites295→300
2025-10-23
Study Status, Contacts/Locations v9
Study sites294→295
2025-09-22
Study Status, Contacts/Locations v8
Study sites291→294
2025-08-25
Study Status, Contacts/Locations v7
Study sitesdetails revised at 10 of 291 sites
2025-07-29
Study Status, Outcome Measures, Eligibility, Contacts/Locations v6
Primary completion date2029-01-19→2028-04-18
Completion date2030-05-23→2030-09-12
Study sites253→291
Eligibility criteria-238 characters
[...] ve concurrent chemoradiotherapy (cCRT) with curative intent within 12 weeks prior to randomization. Exclusion Criteria: Histologically/c [...] ible for the study. Participants with any of the following: Residual disease that needs further treatment with curative intent after definitive cCRT administration; LA-HNSCC that was resected before definitive cCRT LA-HNSCC t [...] therapy (RT) alone as definitive local therapy for LA-HNSCC. Receipt of the last dose of anticancer therapy (chemotherapy and/or RT) > 12 weeks (84 days) prior to randomization.
Secondary endpointsdetails revised at 13 of 13 entries
2024-10-02
Study Status, Contacts/Locations v5
Completion date2030-06-17→2030-05-23
Study sites209→253
2024-05-24
Study Status, Contacts/Locations v4
Study sites195→209
2024-04-05
Study Status, Contacts/Locations v3
Study sites192→195
2024-02-28
Study Status, Contacts/Locations v2
Study sites161→192
2024-01-12
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-11-21→confirmed 2023-12-14
Study sites72→161
2023-11-10
Original filing
AstraZeneca
725 trials monitored
See 68 trials at risk
Head & Neck Cancer
2,051 trials monitored
See 116 trials at risk
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).
Trial Details
NCT Number NCT06129864
Lead Sponsor AstraZeneca
Conditions Locally Advanced Head and Neck Squamous Cell Carcinoma
Enrollment 1,145 participants
Start Date 2023-12-14
Primary Completion 2030-04-17 (estimated)
Study Completion 2031-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-09-30